Manufacturing & Production

Amgen

Associate Manufacturing - Solution Prep (Nights)

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Associate Manufacturing - Nights**

**What you will do**

Lets do this. Lets change the world. In this vital role you will perform operations within the Manufacturing area, specifically solutions, at Amgen's innovative Rhode Island facility. You will be required to know, comprehend, and apply Good Manufacturing Practices (GMP), as well as understand, follow, and document in batch records.

Responsibilities Include:

- Perform batching and transfer of Buffers and Media in appropriate areas according to Standard Operating Procedures (SOPs).
- Follow and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
- Conduct basic troubleshooting and assist in the review of documentation for assigned functions.
- May also have the responsibility of initiating and owning area Deviations, revising SOP's and performing LEAN functions.
- Identify, recommend, and implement improvements related to routine functions.

In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule. This includes extra benefits such as **receiving an added 15% shift differential, and also getting premium pay for any Sundays worked.**  The schedule during the initial on-boarding/training phase (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The driven professional we seek is a self-starter with these qualifications.

**Basic Qualifications:**

- High school/GED + 2 years of manufacturing or operations work experience OR
- Associates + 6 months of manufacturing or operations work experience OR
- Bachelors Degree in a related field

**Preferred Qualifications:**

- Bachelors degree in Science or Engineering
- Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
- Knowledge of Single-use-Systems
- CFR and Regulatory knowledge
- Mechanical ability/expertise
- Basic statistical mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for manufacturing area
- Demonstrated technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on production equipment
- Experience with Delta V
- Experience with lab equipment/testing

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Rhode Island

Associate Manufacturing

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Associate Manufacturing**

**What you will do**

Lets do this! Lets change the world! The Associate of Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant, supporting development, clinical, and launch activities. Under general supervision, this role performs manufacturing operations within Building 23 in accordance with Standard Operating Procedures (SOPs).

This position is responsible for hands-on manufacturing operations, including setup, cleaning, sanitization, media and buffer preparation, and analytical testing.

Key Responsibilities:

- Perform and monitor critical manufacturing processes
- Execute routine validation protocols
- Comply with GMP requirements and all safety and compliance expectations
- Draft and revise routine documents such as MPs, SOPs, and technical reports
- Initiate and own quality records, including CAPA and CAPA-EV
- Identify and recommend improvements to routine functions and implement approved changes
- Perform basic troubleshooting and accurately recognize and report problems
- Direct operators on critical processes
- Assist in the review of documentation for assigned functions, including routine area audits and batch records
- Perform activities that may include rigorous and repetitive work
- Work around high-pressure systems and occasionally around heavy equipment
- Train staff on hands-on tasks, as needed
- Serve as a safety representative, as needed
- Participate on cross-functional teams and represent Manufacturing, as needed
- Apply technical, scientific, operational, and compliance knowledge to support implementation of new technologies into the plant
- Demonstrate strategic problem-solving skills and champion continuous improvement

**Work Environment:**

Must be available to work onsite

Must be able to work in a clean room environment wearing steel-toe shoes, full clean room gowning, hairnet, and gloves while following GMP documentation with strict adherence to safety and compliance

Must be available to work various shifts, including day, swing, graves, weekends, holidays, 5x8-hour shifts, 4x10-hour shifts, and 3x12- or 4x12-hour shifts, as dictated by the production schedule

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications:

**Basic Qualifications:**

- High school diploma / GED and 2 years of manufacturing or operations work experience, or
- Associate degree and 6 months of manufacturing or operations work experience, or
- Bachelors degree

**Preferred Qualifications:**

- Bachelors degree in science or engineering
- Knowledge of large-scale biotechnology operations such as purification, cell culture, and aseptic processing
- Knowledge of single-use systems
- CFR and regulatory knowledge
- Mechanical aptitude
- Basic statistical and mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods used in a manufacturing environment
- Demonstrated technical writing capability
- Project management and presentation skills
- Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles
- Basic troubleshooting skills for production equipment
- Experience with Delta V
- Experience with lab equipment and testing

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

California

Process Development Associate Scientist

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Process Development Associate Scientist**

**What you will do**

Lets do this. Lets change the world. As a Process Development Associate Scientist, you will play an integral part in Amgens Late-Stage Synthetics and Commercial Drug Product team within the Drug Product Technologies department. Your responsibilities will center around gaining practical experience and offering hands-on expertise in formulation and process development for Amgens synthetics pipeline. The core activities of this group involve developing clinical, robust commercial formulations and life cycle management initiatives for a wide array of Amgens synthetic assets.

This position provides the unique opportunity to collaborate with skilled scientists and contribute to the advancement and launch of innovative synthetic drug products across a variety of oral or parenteral dosage forms. Through your work, you will support both the development and commercialization phases, ensuring that Amgen continues to deliver cutting-edge solutions for patients worldwide.

- Hands-on experience in spray-drying formulation and process development, including experimental design, process optimization, data analysis, and characterization of spray-dried materials.

- Understanding of spray-drying process scale-up from laboratory to manufacturing scale, including equipment considerations, technology transfer, process troubleshooting, and identification of critical process parameters and quality attributes.

- Interface within the Drug Product Technologies Department as a team member to support programs and initiatives.

- Contribute to the completion of experimental design and execution and assist in the analysis and interpretation of data.

- Utilize digital tools and emerging AI-enabled solutions to improve experimental efficiency, data analysis, and scientific insight generation.

- Contribute to technical problem-solving efforts and identify opportunities for automation and digital solutions to improve efficiency and reduce repetitive manual tasks.

- Actively contribute to process improvements, strategy development, and cross-functional partnerships that promote consistent and efficient practices across late-stage clinical and commercial synthetic programs.

- Organize and communicate information within the team to help lead to the best possible formulation and processes.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

**Basic Qualifications:**

- Masters degree and 1 years of scientific experience

- OR

- Bachelors degree and 3 years of scientific experience

**Preferred Qualifications:**

- Masters degree in Pharmaceutical Sciences, Chemical or Pharmaceutical Engineering, Chemistry, or a life sciences-related field, with relevant industry experience.

- Understanding of the typical unit operations for the manufacture of oral solid dosage forms (i.e., granulation, roller compaction, drying, milling, blending, compression, film coating, etc.).

- Basic understanding of the physical and chemical stability of synthetic molecules, enabling formulations, amorphous solid dispersions, and how manufacturing processes, including spray drying, HME, roller compaction, and compression, impact product quality.

- Ability to design, execute, and interpret experimental results.

- Strong problem-solving skills applied to the formulation and characterization of parenteral and oral synthetic molecules.

- Excellent written and verbal communication skills for presenting scientific results in a fast-paced, multi-disciplinary environment.

- Proven ability to work effectively in collaborative, team-based settings.

- A proactive, curious, and innovative mindset, with enthusiasm for applying digital solutions to scientific challenges

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Strategic Planning and Operations Manager

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Strategic Planning and Operations Manager - Business Cases**

**Live**

**What you will do**

Lets do this! Lets change the world! In this vital role you will report into the Amgen Ohio (AOH) Portfolio Management Office (PMO) under Business Performance (BP), developing business cases for new product introduction (NPI) and product lifecycle (LCM)/ Patient Impact Extension (PIE) projects.

This role requires an individual who has a deep, end-to-end understanding of multiple business functions, and will play a critical role in advancing the business needs and strategic success of AOH. The successful candidate for this role will be required to develop a very strong network and working relationship with several cross-functional stakeholders, including Operations Strategy & Business Resilience (OSBR), Global Operations Leads (GOLs), Product Delivery Teams (PDTs), Finance, Supply Chain and Corporate Engineering, as well as all site functional teams at AOH. The selected candidate will be expected to adapt to different roles and responsibilities. They should be able to work independently as an individual contributor and take on managerial responsibilities if required. This flexibility is important in ensuring that the candidate can effectively contribute to the team and organization in various capacities.

**The main responsibilities of the role include:**

- Under supervision of the BP/ PMO leader, **lead business cases for the site**, including, but not limited to, product lifecycle projects portfolio, continuous improvement projects portfolio, digital technologies projects portfolio, capital projects portfolio, etc., identify competing priorities and resource constraints for prompt decision making.
- Represent AOH in interactions with Process Development, Global Supply Chain, OSBR, GOLs, Engineering Capital team, Finance, PDTs, etc. for product strategies impacting Amgen Ohio and support the business case process to ensure holistic impact assessments for the site.
- Manage all aspects of business case(s), to include planning, implementation, monitoring, completion, and follow-up, as well as technical and financial requirements.
- Manage competing timelines and prioritize critical tasks.
- Establish and achieve standards for work quality and quantity.
- Assess business case issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
- Assist in technical, financial, and organizational issues by researching issues, providing recommendations, and maintaining document archives.
- Identify and anticipate schedule slips or changes and analyze the costs and resource impact.
- Develop and implement tools, techniques, and processes to provide or create information to enable informed decision making within the teams.
- Actively participate in directing the evolution and defining the role of the business case.
- Ensure the business case goals and objects are well understood by the various functional areas.
- Engage with AOH SLT, functional leaders, sub team leaders and other members of management at AOH to obtain their continued input and feedback on the benefits, needs, and issues associated with the business case portfolio.
- Recommend and develop operational or process improvements for the performance and successful functioning of the team.
- Ensure work complies with regulatory requirements and approved guidelines relevant to area of responsibility.
- Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
- Anticipate resource needs and timely communicate to management sponsors.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a dynamic leader with these qualifications.

**Basic Qualifications:**

Doctorate Degree

Or

Masters degree and 2 years of Project Management and/or Operations and/or Business experience

Or

Bachelors degree and 5 years of Project Management and/or Operations and/or Business experience

OR

Associates degree and 8 years of Project Management and/or Operations and/or Business experience

OR

High school diploma / GED and 10 years of Project Management and/or Operations and/or Business experience

**Beyond that, preferred qualifications are:**

- Experience managing programs and/or project portfolios.
- Experience in developing and successfully implementing cross-functional strategic programs across a network of operational sites.
- Experience working in a global environment, with the demonstrated ability to collaborate closely/communicate effectively at different management levels.
- Executive presence with a strategic thinking skill set and continuous improvement mentality.
- Proficient user of software applications (AI, Excel, PowerPoint, Smartsheet).
- Excellent organizational, leadership, team building and change management skills. This may include negotiating, budgeting, goal setting, resource planning and decision-making.
- Excellent written and verbal communication skills.
- Self-motivated, proactive, independent and adaptable. Flexible to adjust workload based on changing priorities.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Ohio

Grad Co-op Computational Safety Modeling for Small Molecules

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Grad Co-op Computational Safety Modeling for Small Molecules**

**What You Will Do**

Lets do this. Lets change the world. We are seeking a graduate co-op to help expand our computational toolbox for assessing the safety of small molecule drug candidates and potentially other modalities. Working with computational scientists and nonclinical safety experts, you will contribute to a strategy that provides useful predictions early in drug discovery and brings experimental evidence into the assessment as it becomes available.

This role combines scientific data assessment, model development, and collaboration with the researchers who use safety information to guide compound design and testing. The specific toxicity endpoints will be selected with the team based on scientific need and the quality of available data.

**What you will do**

- Identify, curate, and compare relevant external and internal data, including chemical structures, assay results, and exposure information where available
- Develop and evaluate approaches suited to each question. These may include structural alerts, analogue-based read-across, machine learning, and models that integrate experimental results with other safety evidence
- Evaluate performance on compounds relevant to the intended use, and document context of use, uncertainty, applicability, and important limitations
- Work with computational scientists, medicinal chemists, and toxicologists to explore how model outputs can guide compound prioritization and follow-up experiments
- Present results and deliver reproducible analyses, documented model prototypes, and recommendations for further development
- Provide mechanisms for retraining as additional data is generated over time

**Program Eligibility Requirements**

- Must be available to work a part-time schedule.
- Expected continued enrollment in an accredited college or university following the internship program / co-op
- Student must be located in the United States for the duration of the internship program

**What We Expect of You**

We are all different, yet we all use our unique contributions to serve patients. The individual we seek is a team player with these qualifications:

**Basic Qualifications:**

Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria:

- 18 years or older
- Graduated with a bachelors degree from an accredited college or university
- Currently enrolled in an MBA program for an MBA internship OR a Masters program for a Masters internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Masters OR Pharm D OR Ph.D. program before the internship starts

**Preferred Qualifications:**

- Currently pursuing a graduate degree in cheminformatics, bioinformatics, computational chemistry or biology, data science, statistics, toxicology, or a related field
- Experience using Python to analyze scientific data
- Familiarity with statistical modeling and machine learning including the principles of model evaluation
- Ability to communicate technical findings clearly and work with scientists from different disciplines
- Experience with cheminformatics, predictive toxicology, or analysis of in vitro assay data
- Familiarity with small molecule drug discovery or nonclinical safety assessment
- Experience combining data from multiple sources and documenting reproducible computational workflows
- Familiarity with version control and collaborative software development

**What You Can Expect of Us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The base pay range for this opportunity in the U.S. is $35.34 - $41.20 per hour.

- Build a network of colleagues that will endure and grow throughout your time with us and beyond.
- Bring your authentic self to the table and become the professional youre inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
- Participate in executive and social networking events, as well as community volunteer projects.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com - Please search for Keyword R-257124**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

District of Columbia

Process Development Scientist

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Process Development Scientist**

**What you will do**

Lets do this. Lets change the world. In this vital role you will join the Drug Product Technologies (DPT) in Thousand Oaks, California, is seeking a Process Development Scientist to support early clinical development of oral drug products for synthetic molecules. This hands-on laboratory position will focus on formulation and process development for platform immediate-release (IR) tablets and enabling formulations, including amorphous solid dispersions (ASDs). Process characterization will support early clinical supply across these formulations. GMP manufacturing will focus primarily on enabling formulations, particularly ASDs, while also supporting platform IR tablets as needed.

**Key Responsibilities**

Develop and optimize oral drug product formulations and processes for early clinical studies, including platform IR tablets and enabling formulations.

Conduct laboratory studies to characterize materials and formulations, assess process performance, and establish manufacturable approaches.

Collaborate with colleagues across DPT and partner functions, including Drug Substance Technologies, Attribute Sciences, Regulatory Affairs, Supply Chain, Pharmacokinetics and Drug Metabolism, Clinical Pharmacology, and Biostatistics, as well as external manufacturing partners and academic groups.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

**Basic Qualifications:**

- Doctorate degree
- OR
- Masters degree and 2 years of Scientific experience
- OR
- Bachelors degree and 4 years of Scientific experience

**Preferred Qualifications:**

Hands-on GMP manufacturing experience with amorphous solid dispersions (ASDs) produced by hot-melt extrusion (HME) and/or spray-dried dispersion (SDD), including development of manufacturing procedures.

Hands-on GMP experience with roller compaction and tablet compression for immediate-release (IR) tablets.

Experience identifying and troubleshooting issues during GMP processing.

Academic or professional background in pharmaceutical sciences, materials science, bioengineering, or an engineering discipline.

In-depth understanding of pharmaceutical material science and how material properties affect formulation development, process performance, and manufacturability for early clinical programs.

Experience supporting FIH drug product development, including formulation and process development for immediate-release (IR) tablets.

Experience working with contract research or manufacturing organizations.

Experience preparing or contributing to regulatory documentation, such as IND CMC sections, and interacting with regulatory authorities.

Strong communication and collaboration skills, including the ability to work across functions and resolve project-related issues.

Experience with physiologically based biopharmaceutics modeling tools such as GastroPlus or Simcyp.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Process Development Scientist**

**What you will do**

Lets do this. Lets change the world. In this vital role you will join Amgens Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Cambridge, MA, is seeking a highly motivated and team-oriented individual for the position of Process Development Scientist. SET is a key Drug Product Technology interface with partners in Process Development and Research & Discovery. This individual will provide solid state characterization, with a strong focus on solid state NMR (ssNMR) spectroscopy, for drug substance and drug product process development for synthetics and biologics programs in support of SETs key responsibilities which include:

Utilize advanced solid-state characterization methods (e.g. ssNMR) to support drug substance and drug product process development for synthetics and biologics programs.

Drive lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).

Perform synthetics molecule assessment (developability assessment) and preclinical formulation support.

Perform biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.

Provide early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP).

This individual will carry out solid-state analysis and physicochemical characterization to aid solid form and formulation development of drug substances and drug products. The primary responsibilities will include developing, implementing, and applying advanced ssNMR techniques to characterize the structures and interactions of small and large drug molecules. The role will leverage these techniques to investigate and resolve complex scientific questions in pharmaceutical materials science.

Responsibilities:

- Explore and implement ssNMR techniques to enhance productivity, robustness and efficiency of small molecules and biologics development.

- Take a proactive role in developing and applying innovative ssNMR approaches, demonstrating creativity in solving complex technical problems, for example understanding excipient-drug interactions and quantitative analysis of heterogeneous mixtures.

- Provide solid state characterization support to biopharmaceutics assessment, form screening/selection, and drug substance and drug product process development for synthetics and biologics programs.

- Interface with partners in Process Development and Research and Development.

- Support departmental activities including training staff and presenting scientific results at internal/external meetings.

- Build and maintain strong working relationships with key stakeholders internally and externally.

- Contributes to regulatory filings including IND and NDA as needed and assists in answering questions from regulatory authorities. Contributes to Amgens intellectual property and patent filings

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

**Basic Qualifications:**

- Doctorate degree
- OR
- Masters degree and 2 years of Scientific experience
- OR
- Bachelors degree and 4 years of Scientific experience

**Preferred Qualifications:**

- Masters degree in one of the following areas: Physics, Materials Science, Pharmaceutical
- Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline
- Strong background in ssNMR spectroscopy method development and theory with a record of scientific presentations, such as, peer-reviewed publications
- Experience in ssNMR instrumentation, operation, and maintenance is beneficial
- Specific experience developing ssNMR methods to characterize small and large molecule drug substances and drug products, such as solid form analysis, impurity phase/amorphous content detection and physical stability assessment
- Experience in solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.) is desired
- Working knowledge of solid form development such as polymorphism, solvates/hydrates and salt/co-crystal characterization is beneficial
- Good informatics skills and experience with molecular modelling calculations to study molecular interactions and simulate NMR experimental observables is beneficial
- Excellent written, verbal, and presentation skills - ability to distill, craft and present key
- messages relative to diverse audience requirements
- Problem solver with a proactive attitude and ability to collaborate and work in a cross-functional and multidisciplinary environment
- Abilities to take initiatives, work independently, and be flexible in responsibilities

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Massachusetts

Specialist - Manufacturing - Engineering Support

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**What you will do**

Lets do this. Lets change the world! In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), Work Instructions (WI), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

This role will also lead and own quality records such as deviations, CAPAs, Change Controls, and Quality Risk Management and provide expertise in Amgens Quality Management System (QMS).

**Responsibilities may include, but are not limited to:**

- Develop, review, and update technical content including but not limited to SOPs, WIs, risk assessments, protocols & reports for manufacturing team.
- Generate, own, and provide subject matter expertise to Quality System records as minor/major deviations, CAPA and change control records.
- Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents.
- Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.
- Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.
- Support process owners and participate in continuous process improvement and / or troubleshooting projects.
- Support manufacturing team in reducing document turnaround times.
- Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.
- Develop protocols for execution in Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.
- Track pending activities required to support change control implementations.
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
- Share knowledge with members of the manufacturing team.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

**Basic Qualifications:**

Doctorate degree

**Or**

Masters degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

**Or**

Bachelors degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

**Or**

Associates degree and 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

**Or**

High school diploma / GED and 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

**Preferred Qualifications:**

- Educational Background in Science and/or Engineering.
- Experience working in GMP pharma and/or biotechnology industry.
- Experience in a Good Manufacturing Practices (GMP) environment and solid background in technical writing.
- Experience with device assembly and packaging of final product.
- Ability to translate highly technical information into easily understandable information for manufacturing operators.
- Creative skills and usage of photographs, drawings, diagrams, animation, and charts that increase users understanding.
- Experience supporting deviations, investigations, CAPAs and change controls.
- A fact-based problem solver with strong troubleshooting and problem-solving skills.
- Pro-active, result driven, and ability to prioritize work to meet deadlines.
- Good documentation and communication skills.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Associate Manufacturing - Bulk Drug Substance Downstream - Days

**HOW MIGHT YOU DEFY IMAGINATION?**

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Associate Manufacturing - Bulk Drug Substance Downstream - Days**

**Live**

**What you will do**

Lets do this! Lets change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. Thisessentialrole will be part of a team responsible for manufacturingdownstream purification operations including column packing,columnchromatography, TFF,viralfiltration,viralinactivation, conjugation, and final fill,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility.

This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.

During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steadystate operations, the role will shift toward routine manufacturing execution and continuous improvement.

With general direction, the Associate will support all floor operations in accordance withcGMP practices.

**Key Responsibilities:**

**Compliance & Quality**

- Execute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRs

- Ensure proper gowning and aseptic techniques are consistently followed

- Initiate and document manufacturingrelated deviations and quality events as trained

- Support investigations and corrective actions under guidance

- Maintain a strong culture of safety, quality, and compliance

**Operational Readiness & Facility Startup**

- Support operational readiness and facility startup activities as part of the expansion program

- Participate in training, equipment familiarization, and procedure execution to enable startup

- Execute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operations

- Follow defined workflows and procedures to support safe and compliant startup activities

- Provide operational feedback and escalate issues observed during startup execution

**Manufacturing Operations**

- Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas

- Run and monitor critical process tasks per approved procedures

- Perform inprocess sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs)

- Complete washroom activities for small to largescale manufacturing equipment

- Identify and escalate operational issues impacting safety, quality, or schedule

- Maintain an organized, clean, and compliant manufacturing environment

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seekare team players with these qualifications.

**Basic Qualifications:**

- High School/GED + 2 years manufacturing and/or other regulated environment experience

Or

- Associates Degree + 6 months manufacturing and/or other regulated environment experience

Or

- Bachelors Degree

**Preferred Qualifications:**

- Completion of NC BioWorks Certification Program

- Experience in a regulated industry such as biotechnology or pharmaceutical

- Basic understanding and process experience in a cGMP manufacturing facility

- Strong verbal and written communication

- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

- An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

- Ability to work effectively in a team-based manufacturing environment

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

North Carolina

Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days

**Join Amgens Mission of Serving Patients**

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days**

**Live**

**What you will do**

Lets do this. Lets change the world! In this dynamic role, you will be an Associate in the Manufacturing organization at Amgen North Carolina (ANC), supporting the ANC2 facility expansion and startup program. This essential role will be part of the Services team responsible for enabling manufacturing operations through weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation activities, including parts washing and autoclave operations. You will also partner across functions to support successful operational readiness, technology transfer, facility startup, and the ramp-up of manufacturing operations within the new facility.

This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of startup, you will be expected to work a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. As the business transitions from C&Q to manufacturing operations, this essential position will move to a 12-hour, 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., supporting critical 24/7 manufacturing operations.

Because Amgen relies on the regular attendance of all staff members to meet legitimate business needs, individuals in this role must be able to work their assigned 12-hour shift, including during inclement weather, on some holidays, and during requested overtime in support of operations.

During the early phases of the project, this role will focus on operational readiness, training, procedure development, equipment and process familiarization, and startup execution. As the facility transitions to steady-state operations, the role will shift toward routine manufacturing execution, reliable delivery of materials and prepared solutions, equipment operation, cGMP documentation, and continuous improvement.

With general direction, the Associate will support Services floor operations in accordance with current Good Manufacturing Practices (cGMP), applicable procedures, safety requirements, and established production schedules.

**Responsibilities will include...**

**Compliance:**

- Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures \[SOPs\], Manufacturing Procedures \[MPs\], Job Hazard Analysis \[JHAs\], Code of Federal Regulations \[CFR\]) with strict adherence to safety and compliance

- Assure proper gowning and aseptic techniques are always followed

**Process/Equipment/Facilities:**

- Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment in assigned area

- Run and monitor critical process tasks per assigned procedures

- Buffer and Media preparation and transfer

- Weigh and dispense of materials to be used in the preparation of Buffers and Medias

- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records \[EBRs\])

- Complete washroom activities: cleaning equipment, small to large scale, used in production activities

- Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions

- Perform documentation for assigned functions (i.e., equipment logs, EBRs)

- Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities

- Maintain an organized, clean, and workable space

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.

**Basic Qualifications:**

- High School/GED + 2 years manufacturing and/or other regulated environment experience

Or

- Associates Degree + 6 months manufacturing and/or other regulated environment experience

Or

- Bachelors Degree

**Preferred Qualifications:**

- Completion of NC BioWork Certificate Program

- Experience in a regulated industry such as biotechnology or pharmaceutical

- Basic understanding and process experience in a cGMP manufacturing facility

- Excellent verbal and written communication

- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

- An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

- No relocation assistance will be provided for these positions

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Associate Manufacturing**

**What you will do**

Lets do this. Lets change the world. In this vital role you will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs)

Responsibilities:

- Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
- Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
- Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
- Performing and monitoring critical processes with the ability to perform basic troubleshooting
- Performing in-process sampling of equipment and operating analytical equipment
- Performing washroom activities: clean small-scale and large-scale equipment used in production activities
- Maintaining an organized and clean workspace
- Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet, and gloves when performing all work
- Initiating quality deviation records
- Drafting and revising documents (SOPs, MPs)
- Identifying, recommending, and implementing improvements related to routine functions
- Assisting in the review of documentation for assigned functions (example: batch records)
- Performing activities that include periods of rigorous, repetitive work
- Working around high-pressure systems and occasionally working around heavy equipment
- Available to work various shifts (Days, Swings, Graves, Weekends, Holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a go getter with these qualifications

**Basic Qualifications:**

- High school/GED + 2 years of Manufacturing /Operations experience OR
- Associates + 6 months Manufacturing /Operations experience OR
- Bachelors

**Preferred Qualifications:**

- Bachelors Degree in Biology and/or Life Sciences
- Mechanically inclined
- Able to work in teams to complete operational tasks
- Ability to take direction well, follow documents and policies at all times
- Ability to take initiative
- Create a positive work environment through interactions with team members
- Person will have strong capability of scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem solving skills
- Ability to develop and follow detailed protocols
- Independently motivated with ability to multi-task and work in teams

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Global Patient Safety Business Excellence, Senior Manager

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Global Patient Safety Business Excellence, Sr Manager**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will drive business excellence initiatives across Global Patient Safety (GPS), providing leadership in project management, organizational change management, governance, compliance oversight, and operational effectiveness. You will partner across GPS and key cross-functional stakeholders to enable successful delivery of business-critical initiatives, strengthen inspection readiness, and advance a culture of continuous improvement.

**Responsibilities**

- Lead the development, implementation, and continuous improvement of project management and change management standards, methodologies, and best practices across GPS.
- Drive and sustain GPS governance frameworks, ensuring effective oversight, decision-making, and alignment with organizational objectives.
- Lead and deliver business-critical initiatives within Global Patient Safety and represent GPS on enterprise-wide cross-functional programs.
- Provide strategic leadership and oversight for pharmacovigilance activities related to mergers, acquisitions, licensing agreements, and divestitures.
- Contribute to the advancement and effectiveness of the GPS Quality Management System, ensuring compliance with global regulatory requirements.
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Support Health Authority Inspection, Business Partner audits and Internal Process Audits within the remit of role and responsibility, including logistics and operational support
- Develop, monitor, and report key performance and compliance metrics to support management review, strategic decision-making, and continuous improvement.
- Facilitate cross-functional management of deviations, CAPAs, and quality improvement initiatives to ensure sustainable compliance outcomes.
- Build and maintain strong partnerships with internal and external stakeholders, influencing decisions and driving alignment across complex organizational initiatives.
- Champion digital transformation opportunities, including the adoption of automation, analytics, and emerging technologies to enhance Global Patient Safety.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The safety business excellence professional we seek has these qualifications.

**Basic Qualifications:**

Doctorate degree & 2 years ofSafety Project Management experience

OR

Masters degree & 4 years ofSafety Project Management experience

OR

Bachelors degree & 6 years ofSafety Project Management experience

OR

Associates degree & 10 years ofSafety Project Management experience

OR

High school diploma / GED & 12 years ofSafety Project Management experience

**Preferred Qualifications:**

- Demonstrated expertise in project management, change management, and organizational transformation.
- Strong leadership acumen and the ability to influence without authority
- Able to comprehend pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills
- Critical thinking and decision-making skills; comfort with ambiguity and able to work independently as needed
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Demonstrated ability to leverage digital technologies, automation, and data-driven insights to improve operational effectiveness and business outcomes.
- Strength in facilitation, both virtual and in person (including with executive leadership)
- PMP certificationor equivalent in Change or Project Management
- A history of successful execution of major projects in regulatory or safety environment
- Experience of mergers, acquisitions and divestitures in Life Sciences
- Strong leadership experience, ideally with fully remote teams across time zones
- Significant experience within pharmacovigilance, drug safety, regulatory affairs, quality, or related life sciences functions.
- Proven experience establishing governance frameworks and leading complex, enterprise-wide initiatives.
- Experience presenting to and influencing senior leadership and executive stakeholders.
- Strong analytical skills with the ability to translate data into actionable business recommendations.
- Experience leading process improvement initiatives using Lean, Six Sigma, Agile, or similar methodologies.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Process Development Associate - Biological and Structural Characterization

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Process Development Associate Biological and Structural Characterization**

**What you will do**

Lets do this. Lets change the world. In this vital role you will help make a lasting impact on the lives of patients.

- Implementing state-of-the-art and fit-for-purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
- Assisting in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions
- Generating and analyzing analytical data to support: product development and regulatory submissions
- May contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation and data interpretation. Keeps current in analytical development field including literature and technology development. Supports analytical projects involving method development, qualification, and transfer

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Bachelors degree

OR

Associates degree and 2 years of Operations experience

OR

High school diploma / GED and 4 years of Operations experience

**Preferred Qualifications:**

- Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
- Experience in cell-based bioassay development (characterization methods, qualification, validation, technical transfer)
- Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies
- Innovation supports new ideas and initiatives
- Detail oriented and excellent documentation skills
- Experience with automated liquid handling preferred
- Client orientation establishes effective and responsive relationships with all clients; ensures value is delivered
- Communication and Interpersonal skills communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Sr. Process Development Engineer Combination Products & Device Engineer

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Sr. Process Development Engineer Combination Products & Device Engineer**

**What you will do**

Let's do this. Let's change the world. In this role, the Sr. Process Development Engineer reports to the Associate Director of Process Development and serves as the technical leader and Subject Matter Expert (SME) for combination products, drug delivery devices, and automated assembly technologies supporting commercial Combination Product and Final Drug Product (FDP) operations at the Amgen Ohio site.

This position combines advanced device engineering expertise with process development leadership to support the development, commercialization, technology transfer, lifecycle management, and continuous improvement of auto-injectors and other combination products. Working in a highly collaborative cross-functional environment, you will lead initiatives spanning device engineering, manufacturing process development, equipment implementation, validation, and regulatory compliance to ensure reliable, compliant, and efficient commercial manufacturing.

**Process Development & Manufacturing Support**

The Sr. Engineer applies advanced engineering and scientific principles to support the development, commercialization, and lifecycle management of combination products and manufacturing technologies. This role provides technical leadership for process development, technology transfer, equipment implementation, and manufacturing support to ensure safe, reliable, and compliant commercial operations.

**Key Responsibilities**

- Serve as the site Subject Matter Expert (SME) for combination products, auto-injectors, and device assembly technologies.
- Lead the development, implementation, and optimization of automated and semi-automated combination product assembly equipment.
- Support product commercialization, design transfer, and technology transfer into commercial manufacturing.
- Develop and execute engineering studies, characterization plans, test methods, protocols, and reports supporting product development and manufacturing.
- Analyze engineering and manufacturing data to evaluate product performance, process capability, and manufacturing robustness.
- Provide technical support for device assembly, labeling, packaging, manufacturing scale-up, and commercial product launches.
- Characterize manufacturing equipment/processes and implement engineering solutions to improve throughput, quality, equipment reliability, and operational efficiency.
- Travel up to 20% domestically and internationally as required to support project execution, technology transfer, equipment suppliers, and manufacturing sites.

**Technical Leadership & Equipment Validation**

As the technical leader for device assembly technologies, you will provide engineering expertise throughout the equipment and product lifecyclefrom concept and qualification through commercial manufacturing. This role ensures compliance with design controls, GMP requirements, and global regulatory standards while resolving complex technical challenges.

**Key Responsibilities**

- Lead product verification, characterization, and performance testing to demonstrate product safety, functionality, and design robustness.
- Translate user needs and design requirements into technical documentation, manufacturing specifications, and engineering deliverables.
- Author and provide technical leadership for regulatory submissions, technical reports, Design History File documentation, and quality records.
- Lead root cause investigations and provide technical oversight for deviations, change controls, CAPAs, and implementation of sustainable corrective actions.
- Support equipment lifecycle management, process monitoring, and continuous process verification while coordinating technical activities with internal engineering teams and equipment suppliers.

**Project Leadership & Cross-Functional Collaboration**

The Sr. Engineer leads complex technical projects and collaborates across the Amgen network to successfully deliver innovative device and manufacturing solutions. This role provides technical direction, manages project execution, and builds strong partnerships with internal and external stakeholders.

**Key Responsibilities**

- Site SME collaborating with cross-functional engineering teams supporting combination product and device technology programs.
- Manage project scope, schedules, technical deliverables, risks, budgets, and resource planning.
- Provide technical leadership across Process Development, Manufacturing, Quality, Regulatory Affairs, Device Engineering, and external partners.
- Coordinate technical activities with equipment suppliers and development partners to support equipment implementation, component qualification, and commercialization.
- Communicate project status, technical recommendations, and business impacts to leadership and key stakeholders.
- Build technical partnerships across Amgen's commercial manufacturing network to leverage best practices, standardize manufacturing approaches, and support future product introductions.

**Operational Excellence & Continuous Improvement**

The Sr. Engineer champions Operational Excellence by applying data-driven engineering principles to improve manufacturing performance, equipment reliability, product quality, and process capability. This role identifies and implements sustainable improvements that enhance operational efficiency and reduce manufacturing risk.

**Key Responsibilities**

- Lead continuous improvement initiatives for device assembly, packaging, and manufacturing operations.
- Troubleshoot complex manufacturing and equipment issues using structured engineering and statistical problem-solving methodologies.
- Apply statistical tools including Design of Experiments (DOE), Statistical Process Control (SPC), capability analysis, and data trending to optimize process performance.
- Support risk assessments, Failure Mode and Effects Analysis (FMEA), and process optimization activities to improve product quality and manufacturing robustness.
- Develop standardized engineering practices, equipment strategies, and technical solutions that improve productivity, capacity, and operational performance across the manufacturing network.
- Mentor engineers and contribute to the development of technical capabilities and engineering best practices.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The process development professional we seek will possess these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of Engineering/Operation in GMP regulated environment experience

Or

Bachelors degree and 4 years of Engineering/Operation in GMP regulated environment experience

Or

Associates degree and 8 years of Engineering/Operation in GMP regulated environment experience

Or

High school diploma / GED and 10 years of Engineering/Operation in GMP regulated environment experience

**Preferred Qualifications:**

- Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or another engineering or science-related discipline.
- Experience supporting manufacturing, operations, process development, device engineering, or combination product development within a regulated industry.
- Experience in the development, commercialization, lifecycle management, and manufacturing support of medical devices, combination products, drug delivery systems, auto-injectors, prefilled syringes, or related technologies.
- Demonstrated expertise with combination product assembly equipment, automated and semi-automated manufacturing systems, and applicable product testing methodologies.

Strong understanding of medical device and combination product regulations, including:

- FDA Quality System Regulation (21 CFR Part 820)
- Combination Product Regulations (21 CFR Part 4)
- ISO 13485 Quality Management Systems for Medical Devices
- ISO 14971 Risk Management for Medical Devices
- EU Medical Device Regulation (EU MDR 2017/745)
- Applicable ASTM, ISO, and compendial standards

- Working knowledge of Design Controls, including Design Planning, Design Verification, Design Validation, Design Transfer, Design History Files (DHF), and Risk Management.
- Experience supporting device assembly, final drug product (FDP) manufacturing, labeling, packaging operations, technology transfer, process validation, and commercial manufacturing.
- Experience leading commissioning, qualification, and validation (CQV) of manufacturing equipment and supporting GMP manufacturing operations.
- Demonstrated experience working with device, equipment, and component suppliers to support equipment design, qualification, technology transfer, and commercialization.
- Proficiency with CAD software (SolidWorks preferred), engineering drawings, assemblies, and technical documentation.
- Experience applying statistical engineering tools including Design of Experiments (DOE), Statistical Process Control (SPC), capability analysis, data trending, and engineering data analysis.
- Demonstrated expertise in structured problem solving, root cause analysis, risk assessments, Failure Mode and Effects Analysis (FMEA), and implementation of corrective and preventive actions (CAPA).
- Proven track record of leading complex cross-functional engineering projects from concept through commercialization while managing multiple priorities, timelines, and technical deliverables.
- Excellent project management, organizational, and technical leadership skills with the ability to influence decisions across a matrix organization.
- Exceptional written, verbal, and technical communication skills, including experience authoring engineering documentation, validation protocols, technical reports, and regulatory submissions.
- Strong interpersonal skills with the ability to collaborate effectively across Process Development, Device Engineering, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external partners.
- Demonstrated ability to work independently, adapt to changing business priorities, and thrive in a fast-paced, highly regulated manufacturing environment.
- Passion for Operational Excellence, continuous improvement, innovation, and mentoring others while fostering a collaborative, patient-focused culture.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Senior Process Engineer

**HOW MIGHT YOU DEFY IMAGINATION?**

Youveworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experienceand passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over10 million patientsworldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility not only featuresthe best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integratessustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company.

**Senior Process Engineer**

**Live**

**What you will do**

Letsdo this.Letschange the world. In this vital role youwill be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production.This role will develop domainexpertiseand system ownershipto supportprocessoperations, focusing onDownstream Process engineering.

**Responsibilities include:**

- Provide system ownership forBiopharmaceutical process equipment.Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

- Effectively collaborate with key customers and support groups (e.g.Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.

- Develop equipment maintenance programs, ensure the availability of spare parts, andcoordinatingmaintenance activities to ensure systems are in proper working order.

- Ensure systems are installed and operatingsafetyand stayin syncwith pertinent environmental health/safetypractice,rulesand regulations.

- Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.

- System guidance toidentifyperformance risks and implement risk reduction strategies.

- Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.

- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

- Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.

- Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.

- Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for theprocessequipment.

- Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments,identifyinggaps and owning their remediation, implementing equipment modifications, and supporting engineering runs.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. Theengineeringprofessional weseekenjoys challenges and is motivated to help serve patientswith these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and2years of Engineering experience

OR

Bachelors degree and4years of Engineering experience

OR

Associates degree and8years of Engineering experience

Or

High school diploma / GED and10 years of Engineering experience

**Preferred Qualifications:**

- Bachelors degree in Chemical or Mechanical Engineering

- 6+years'of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environmentwith a focus onDownstreamunit operations

- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.

- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

- Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation

- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects

- Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation

- Understanding ofsafety requirements working in a GMP Biopharmaceutical Production facility.

- Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork

- Collaborative teammate prepared to work in and embrace ateam-basedenvironment that relies on communication for effective decision-making

- Strong leadership, technical writing, and communication/presentation skills

- Work schedule flexibility asrequiredto support 24/7 operations, requiring occasional after-hours engineering coverage

- Ability for domestic/international travel(~10%)

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

\#AmgenNorthCarolina

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Global Process Owner - Warehousing, Distribution & Supply Chain Security

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Global Process Owner - Warehousing, Distribution & Supply Chain Security**

**What you will do**

Lets do this. Lets change the world. In this vital role you will own global QMS processes for Warehousing & Distribution (W&D) and Supply Chain Security (SCS), ensuring standardization and consistency across the network.

**Responsibilities:**

Define, maintain and continuously improve global QMS processes and standards for W&D/SCS.

Lead in shaping the strategic direction and future-state roadmap for W&D/SCS QMS processes, in partnership with key stakeholders.

Monitor regulatory developments and interpret their potential impact on global processes, standards and controls.

Provide strategic guidance for risk-based assessments, ensuring quality and compliance risks appropriately inform global priorities and actions.

Establish and maintain process governance, including performance metrics, risk indicators, escalation mechanisms and management reporting.

Lead cross-functional initiatives to strengthen global process effectiveness and compliance.

Partner closely with Quality and the broader GMP/GDP network to align standards, expectations and implementation.

Provide leadership and subject-matter expertise in audit and inspection response strategies and management reviews.

Lead change management associated with QMS process and regulatory changes.

Build and leverage a global network of SMEs and stakeholders to drive alignment, informed decision-making and effective execution.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Supply Chain professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Doctorate degree and 2 years of Supply Chain experience

OR

Masters degree and 4 years of Supply Chain experience

OR

Bachelors degree and 6 years of Supply Chain experience

OR

Associates degree and 10 years of Supply Chain experience

OR

High school diploma / GED and 12 years of Supply Chain experience

**Preferred Qualifications:**

Minimum 2 years leadership experience.

Strong knowledge and demonstrated application of GMP/GDP regulations and Quality Management Systems within a pharmaceutical or similarly regulated environment.

Demonstrated ability to interpret regulatory requirements and translate them into pragmatic, risk-based processes and controls.

Strong understanding and application of quality/compliance risk management principles.

Experience leading global processes, governance or significant cross-functional initiatives.

Experience supporting and/or leading regulatory inspections and audits.

Strong understanding of warehousing, distribution and supply chain processes.

Demonstrated ability to lead and influence across a complex, global matrix.

Operational Excellence / continuous improvement and process performance management experience.

Experience as a Global Process Owner or in comparable global process leadership.

Pharmaceutical warehousing/distribution and cold-chain experience.

Experienced with AI-enabled tools or technologies (e.g. machine learning, automation, advanced analytics)

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

AbbVie

Distribution Analyst

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Position Summary:**

We are looking for a highly motivated and analytical Senior Distribution Analyst to serve as the primary owner for customer-facing distribution execution and outbound operations across key US distribution centers.

This role will support the US Distribution Manager by leading day-to-day outbound execution across the distribution network, including delivery monitoring, open delivery review, delivery block resolution, delivery push requests, zero-pick investigations, warehouse cancellations, export coordination, LTL and partial shipment management, HVR/LVR management, VAS support, product complaint returns/OZ requests, outbound IDOC monitoring and resolution, distribution process optimization, logistics data analysis, and investigation of shipment delays, damages, discrepancies, and other operational inefficiencies. The Senior Distribution Analyst will partner closely with distribution centers, Customer Service, Quality, BTS, Transportation, Trade Compliance, Planning, and other cross-functional stakeholders to drive timely issue resolution, improve operational flow, strengthen warehousing and delivery performance, and ensure service commitments are met for customers and patients.

**Position Responsibilities:**

- Own day-to-day outbound operational support across all US/PR distribution centers, ensuring consistent execution of order fulfillment, shipment readiness, dock activity, carrier handoffs, and issue escalation in alignment with service, compliance, and customer commitments.
- Perform daily delivery monitoring and open delivery reviews across the outbound network to identify aging deliveries, delayed pick/pack activity, blocked orders, shipment discrepancies, and other risks requiring cross-functional follow-up.
- Lead resolution of delivery blocks, delivery push requests, zero-pick investigations, and warehouse cancellations by identifying root cause, aligning owners, documenting actions, and driving timely closure with distribution centers, Customer Service, Planning, Quality, Transportation, and BTS as needed.
- Serve as a key operational escalation point for Customer Service by investigating order fulfillment issues, delivery status concerns, partial shipment impacts, cancellation requests, and urgent customer needs while ensuring clear communication of status, next steps, and ownership.
- Monitor and resolve outbound SAP IDOC issues by partnering with BTS, 3PL partners, and internal operations teams to troubleshoot failures, validate corrections, reduce recurring errors, and support accurate system-to-system transaction flow.
- Support Value Added Services operations by coordinating VAS readiness, execution timing, inventory availability, labeling or packaging requirements, exception management, and post-activity reconciliation to ensure compliant and on-time customer fulfillment.
- Support HVR/LVR processes by monitoring order/release activity, coordinating with distribution centers and cross-functional partners, resolving exceptions, and ensuring appropriate prioritization, documentation, and timely execution in support of customer and business requirements.
- Support product complaint return activity, including OZ requests, by coordinating return authorization needs, partnering with Customer Service, Quality, distribution centers, and transportation teams, tracking status through closure, and escalating delays or documentation gaps as needed.
- Optimize distribution processes: Analyzing and improving the efficiency and effectiveness of the physical movement of goods.
- Analyze data: Interpreting data related to warehousing and delivery performance.
- Identify and resolve distribution inefficiencies: Investigating and addressing issues such as delays, damages, or discrepancies in shipments.

Qualifications

**Education:**

- Preferred Bachelor’s degree or below equivalent experience, preferably in business or supply chain

**Skills and Competencies:**

- Experience with fulfillment services, warehouse operations, warehouse design, and system configuration support
- Familiarity with warehouse management systems, including WMS platforms used by external 3PL partners
- 5 years’ experience in warehousing, distribution, and/or supply chain management
- Hands-on experience applying basic to advanced analytics tools and techniques to monitor operational performance and support issue resolution
- Ability to analyze and interpret data to identify trends, assess root causes, and support timely operational decisions
- Strong analytical mindset with demonstrated ability to use data-driven decision making to prioritize operational issues, support root cause analysis, and drive continuous improvement across distribution execution.
- Demonstrated ability to identify distribution inefficiencies, evaluate shipment delays, damages, and discrepancies, and coordinate corrective actions that improve physical goods movement, warehousing performance, and delivery reliability.
- Strong cross-functional collaboration skills with Information Technology/BTS, Commercial, Finance, Supply Chain, distribution centers, external 3PL partners, and stakeholders at varying levels of the organization
- Extensive knowledge of SAP, S/4, JDA, external 3PL WMS platforms, and/or other similar distribution and supply chain systems.
- Well-developed interpersonal skills including strong presentation, verbal, and written communication skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Eli Lilly and Company

Lead Operator - Aseptic Filling (Night Shift)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Lead Operator - Aseptic Filling (Day Shift)**

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Company Overview**

At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

**Responsibilities**

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company’s capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.

If you ever wanted to have a direct impact building a team’s culture and in how the team operates, now is the perfect opportunity!

During the project phase, the Parenteral (PAR) Lead Operator will support start up activities required to bring the aseptic isolator barrier filling area into service. They will become the experts within their assigned area and educate their team in the proper operation of the facility. The Lead roles are expected to become the leaders for the PAR equipment and process and will lead the training of new staff.

After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Lead Operators will coordinate daily activities to meet capacity plans while developing their own and our team’s capabilities.

As a site leader and expert at our growing site, you’ll have significant opportunities for growth into future leadership and technical roles.

**Integrity**

- Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
- Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
- Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.

**Excellence**

- Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
- Responsible for administering technical training and ensuring all operators are trained to perform tasks.
- Operate the equipment and perform activities as required to meet production schedule.
- Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
- Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.

**Respect for People**

- Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
- (Lead role) Assist Supervisor in development and performance evaluations of shift operators. Act as backup for Supervisor.
- Key liaison between operations and support functions.

**Basic Qualifications/Requirements**

- High School Diploma/GED
- Minimum 5 years of experience working with automated equipment in a GMP/cleanroom environment
- Minimum 3 months leadership experience and the ability to train / educate team members
- Minimum 3 months experience working with computers (desktop software, MS office, HMI's, electronic batch records/systems).
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

**Additional Preferences**

- STEM degree or certification
- Ability to effectively communicate (electronically, written and verbal)
- Flexibility - the ability to troubleshoot and triage challenges
- Knowledge of aseptic filling, single use assemblies, isolator technology.
- Automated, semi-automated, and/or manual inspection experience.
- Knowledge of current Good Manufacturing Practices (cGMPs)
- Experience in operations or manufacturing environments.
- Pharmaceutical, medical device or food processing industries
- Manufacturing Execution Systems and electronic batch release.
- Continuous improvement (Lean, Six Sigma methodologies)
- Highly automated equipment (inspection, packaging, filling, assembly, etc.)
- SAP, Electronic Batch Records

**Additional Information**

- Must be able to work B shift (6pm to 6am on 2-2-3 schedule)
- Must Pass a “fitness for duty” physical exam
- Ability to work overtime as required
- Ability to wear safety equipment (glasses, shoes, gloves, etc)
- Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
- Ability to participate in professional development opportunities (team coursework such as classes through RCCC).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$27.40 - $40.19

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Sr. Advisor - Engineering Design Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through partnerships with design, construction and qualification contractors.

Many of the assets delivered focus on manufacturing of medical innovations and delivering innovative solutions to patients and support an expansion in supply of existing medicines.

Responsibilities for a Sr. Advisor - level DL (Design Lead) include:

- Overall design delivery for capital project(s) for a complex project node or workstream and is internally/externally recognized as a SME in node platform technology.
- DL teams will be a mixture of Lilly team members and external partners fully accountable in the project location for project technical success.
- Directly influences Sr. Management on asset design and/or delivery approaches.
- Lead the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
- Actively leads delivery team to expand on their knowledge of design processes based on a history of project delivery.
- Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
- Direct the development of the design requirements.
- Command of the design schedule to meet the project needs.
- Often participate in the selection of the A/E firms.
- Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
- Own design decisions and coordinate information flow between the design team and system owners.
- Responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer. Clear articulation of want vs need for asset and facility requirements.
- Responsible for design activities and governance, resolving design-related problems.
- Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
- Instruct the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices. Influences the network in the adoption of those industry best practices.
- Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
- Work with Engineering Tech Center resources and other key project team technical/constructability resources to address and resolve design issues, and issue formal reports accordingly. Influences key technical decision makers on issues of corporate significance.
- Ensures replication is achieved during design when applicable, even in new situations.
- Support the Project Manager for value engineering exercises efforts to maximize project opportunities and deliver significant site impact and directly contribute meaningful ways to reduce cost through design.
- Participate in KPI reviews/assessments.
- Participate in the selection of the verification professional services.
- Accountable for the development of the Project Verification Plan, Traceability Matrix, and risk assessments (not necessarily lead the execution).
- Coordinate verification for the Project Manager during the verification phase of the project.
- Accountable for the discrepancy tracking and management in the Verification phase and uses root cause investigation techniques to resolve problems.

Basic Qualifications:

- BS in Engineering (Chemical or Mechanical strongly preferred)
- Minimum of 15 years manufacturing and/or engineering in support of pharmaceutical or API networks

Additional Preferences:

- Strong manufacturing and engineering background.

Additional Information:

- Travel is required for this role (20%, 1-2 weeks/month until relocation to project site)
- Ability to work at the site of the project on a weekly basis. This position reports through Indianapolis but is located at site of the supported project.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$130,500 - $211,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Alabama

Advisor - TS/MS - Oligonucleotides Technical Steward

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, Texas. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations.

**Main Purpose and Objectives:**

This position is part of the Technical Services & Manufacturing Sciences (TSMS) function and is responsible for Oligonucleotide stewardship and site transfer of commercial molecules, as well as commercialization support for new molecules. This position will interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments. Interaction may be required with other Lilly site/contract producers of Lilly products.

This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas in oligonucleotides.

**Key Responsibilities:**

- Provides technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility. If necessary, leads the technical transfer of processes from one production facility to another, anticipating and addressing complex scale-up issues.

- Provides mentorship and scientific expertise to Process Team members monitoring, trending, and analyzing production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. May present process data and analyses with Process Team members at Manufacturing Process Team meetings. Drives solutions impacting results across sites or function.

- Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies. Reviews/approves Annual Product Review and presents annual Global Product Assessment for stewarded molecule(s).

- Leads resolution of technical issues including those related to control strategy and manufacturing

- Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves key technical or operational problems that impact function or geography. Communicates issues in a timely manner. May lead process-related investigations and assess technical impact. Influences complex regulatory or technical issues within the TSMS area/function. Influences others to adopt a different point of view on difficult concepts.

- Writes standard operating procedures as they relate to the activities of the TSMS group. Reviews and approves manufacturing batch records and other manufacturing documentation.

- Works with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor. Assists in process-related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.

- As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement medium to large continuous improvements to manufacturing processes.

- Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. Helps to define and implement control strategies for Lilly Houston processes.

- Leads post launch technical agendas and delivers projects that drive substantial step changes in Manufacturing.

- As required, may lead, or assist in the planning and execution of process validation activities.

- As required, may own, or assist in the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity.

- Makes decisions that impact a function or geography. Builds relationships with internal and external partners.

- Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.

**Minimum Requirements:**

- Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biochemical engineering or related science field.
- Minimum of 10 years of experience in cGMP oligonucleotide, peptide, or small molecule API commercial-scale manufacturing.

**Additional Preferences:**

- Masters or PhD preferred.
- Process validation, cleaning validation, and commercialization experience a plus.
- Demonstrated leadership skills.

- Excellent communication skills, both oral and written.
- Process and equipment knowledge of chemical synthesis active pharmaceutical ingredients.

- Thorough understanding of cGMP requirements for a large-scale manufacturing facility.

**Additional Information:**

- Off-hours support may be needed, by request.
- Required to respond, off shift, to operational issues.
- Minimal travel required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$130,500 - $211,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly