Engineering

Amgen

Senior Manufacturing Systems Engineer: Building Automation Systems (BAS)

**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. 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.

**HOW MIGHT YOU DEFY IMAGINATION?**

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be 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.

**Senior Manufacturing Systems Engineer: Automation - BAS / PLC**

**Live**

**What you will do**

Lets do this. Lets change the world. As a Senior Manufacturing Systems Engineer, you will provideautomationtechnical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP DrugSubstancePlant Operations.

In this vital roleas a member of the Facilities & Engineering (F&E) Automation teamyou will work hand in hand with the capital project team to deliver robust **building automation systems (BAS) and PLC based process and utility skid equipment** to operate the new plant.

**Job responsibilities include:**

- **Site design, construction, start-up, and operational readiness:**
  - Collaborate with key stakeholders to understand key process requirements and synthesize feedback from clients, customers or end-users to develop the best automation solutions using Amgen standard automation platform for building automation systems and process and utility skid equipment.
  - Develop and maintain engineering and maintenance documentation and associated procedures for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and industry standards.
  - Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
  - Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy for the building automation systems and process and utility skid equipment in support of the project delivery.
  - Work with platform leads to ensure standalone PLC based systems are designed with the proper network connectivity to enable centralized monitoring and alarming.
  - Support design phases to ensure equipment aligns with Amgens specifications, incorporates the latest technology and meets safety requirements.
  - Lead vendors FAT (for the automation testing) and ensure that control strategy and software code meet Amgens requirements. Emphasize on understand the benefits of a complete and successful FAT will be a contributive factor to successful and on time project delivery.
  - Understand the manufacturing operation and ensure the control strategy aligns with existing manufacturing operations to facilitate release and operation of equipment, especially applicable for retrofit type of projects adding to an existing control system.

- **Site Operations:**
  - Act as system owner for building automation system and standalone PLC based systems responsible for System Administration, maintenance procedures and job plans, spare parts and engineering documentation.
  - Responsible for owning and driving to completion Change Controls, CAPAs, and Deviations as applicable to the assigned automation system to ensure reliability and compliance.
  - Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
  - Drive continuous improvement for utility and building equipment systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
  - Lead/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation systems.
  - Provide day-to-day Operational Support including:rotational on call operational Support for building automation systems and process and utility skid equipment.
  - Perform and maintain data integrity assessments in accordance with the current Amgen Global Standard procedures and applicable standards.

**Win**

**What we expect of you**

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

**Basic Qualifications:**

- High School Diploma / GED and 10 years of Engineering experience OR
- Associates Degree and 8 years of Engineering experience OR
- Bachelors Degree and 4 years of Engineering experience OR
- Masters Degree and 2 years of Engineering experience OR
- Doctorate Degree

**Preferred Qualifications:**

- Degree in Electrical Engineering or Computer Science, Chemical Engineering,Biotech Engineering, or related field.
- Direct knowledge of BMS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software.
- Experience with building automation systems and process and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies.
- Knowledgeable of industry standards such as 21 CFR Part 11, ASTM 2500, S95, GAMP 5, and GDP.
- Experience in programming, design, installation and lifecycle management of building automation controls, PLC and field device/instrumentation technologies.
- Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, and S95.
- The ideal individual must be a self-directed team player able to work cross-functionally.
- Strong leadership, technical writing, and communication/presentation skills.
- Ability for domestic/international travel as needed.

**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, including remote and hybrid 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**

**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.

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. 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

Software 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.

**Software Engineer**

**What you will do**

Lets do this. Lets change the world. In this vital role you will contribute to the development and maintenance of our web applications by working on both front-end and back-end technologies. This role is ideal for early-career professionals looking to take on challenges in software development.

- Develop and maintain front-end applications using HTML, CSS, and JavaScript frameworks, preferably ReactJS.
- Develop and manage back-end services using languages such as Python or Node.js, leveraging AWS cloud infrastructure.
- Experience building or integrating applications with generative AI, LLMs, agentic workflows, RAG patterns, or AI orchestration frameworks.
- Create innovative solutions leveraging the latest technologies.
- Collaborate with the design and product teams to understand user needs and translate them into technical requirements.
- Write clean, efficient, and well-tested code.
- Participate in code reviews and provide constructive feedback.
- Maintain system uptime and optimal performance
- Learn and adapt to new technologies and industry trends

**What we expect of you**

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

**Basic Qualifications:**

Masters degree

OR

Bachelors degree and 2 years of software development experience

Or

Associates degree and 6 years of software development experience

Or

High school diploma / GED and 8 years of software development experience

**Preferred Qualifications:**

Functional Skills:

**Must-Have Skills:**

- Hands on experience with web development, proficient with HTML, CSS, JavaScript
- Hands on experience with backend development, proficient with SQL/NoSQL database, proficient in Python and SQL
- Ability to learn new technologies quickly. Strong problem-solving and analytical skills. Excellent communication and teamwork skills.

**Good-to-Have Skills:**

- Experienced with API integration, serverless, microservices architecture.
- Experience building or integrating applications with generative AI, LLMs, agentic workflows, RAG patterns, or AI orchestration frameworks.
- Experience in SQL/NOSQL database, vector database for large language models
- Experience with popular large language models
- Experience with various frameworks like Langchain or llamaIndex for developing applications
- Experience with prompt engineering, model fine tuning
- Experience with DevOps CICD build and deployment pipeline
- Experience with design patterns, data structures, test-driven development.

**Education and Professional Certifications:**

- Bachelors degree in computer science and engineering preferred, other Engineering field is considered.
- Cloud Computing certificate preferred

**Soft Skills:**

- Excellent analytical and troubleshooting skills.
- Strong verbal and written communication skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals
- Strong presentation and public speaking 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.

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

Manufacturing Process Technician - Bulk Drug Substance Manufacturing Services - Night Shift

**HOWMIGHT 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 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 Process Technician - Bulk Drug Substance Manufacturing Services - Night Shift**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be a Mfg. Process Technician in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations,works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. Mfg. Process Technician will complete operations on the floor in the Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substances.

With general direction for routine work and detailed instructions for new assignments, the Mfg. Process Technician will support all floor operations in accordance withcGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.

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.

- Ensure proper gowning and aseptic techniques are always followed

Process/Equipment/ Facilities:

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

- Buffer and Media preparation and transfer

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

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

- Run and monitor critical process per assigned procedures

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

- Maintain an organized, clean, and workable space

**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 diploma / GED + 1 year of manufacturing and/or other regulated experience

Or

- Associates degree

**Preferred Qualifications:**

- Completion of NC BioWorks Certificate Program

- Experience in a regulated industry such as biotechnology or pharmaceutical

- Basic understanding of GMP principles

- Strong verbal and written communication skills

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

- Ability to perform assignments with a high degree of focus/attention to detail.

**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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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.

Director, Bioprocess / Process Development Pivotal Drug Substance

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.

**Director, Bioprocess / Process Development Pivotal Drug Substance**

**What you will do**

In this leadership role, you will be responsible for the development, characterization, scaleup, and support of drug substance cell culture and purification processes to enable commercial advancement of programs from Phase II/III through marketing applications. Located in Cambridge, MA and/or Thousand Oaks, CA, you will lead and develop a multisite organization of 30+ scientists and engineers while driving program success, safety culture, technical excellence, innovation, automation, and digital strategies.

You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel proteinbased modalities, and play a key role in advancing latestage and commercial drug substance strategies across Amgens manufacturing network.

**Key Responsibilities**

- Lead a highimpact, multifunctional drug substance organization integrating cell culture and purification disciplines across multiple sites.
- Recruit, develop, and retain a strong and diverse team; manage portfolio prioritization and organizational resourcing.
- Advance integrated drug substance processes through commercial process development, process characterization, lifecycle management, and control strategy development.
- Partner with engineering, manufacturing, and external network collaborators to enable successful process transfer and commercialization.
- Author and review global regulatory filings (IND/INDa/MA) and respond to regulatory agency questions.
- Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies.
- Contribute to Amgens scientific and regulatory eminence through publications, patents, and participation in external conferences and forums.
- Serve as a member of the Drug Substance Technology extended leadership team and contribute to business, organizational, and changemanagement strategies.

**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:**

- Doctorate degree and 4 years of scientific process development experience, OR
- Masters degree and 8 years of scientific process development experience, OR
- Bachelors degree and 10 years of scientific process development experience And

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
- 10+ years of experience in biopharmaceutical process development
- Minimum of 4 years of experience directly managing people
- Deep expertise in either cell culture bioreactor processes OR downstream purification processes
- Strong understanding of latestage biologics development including process design, characterization, validation (PPQ), and regulatory interactions
- Proven ability to provide scientific and engineering leadership on complex crossfunctional programs
- Demonstrated experience in statistical data analysis, technical decisionmaking, and seniorlevel communication
- Track record of developing talent through coaching, mentoring, and feedback
- Active engagement in the scientific community (publications, patents, industry forums)

**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

Process Development Sr Principal 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 Sr Principal Scientist**

**What you will do**

In this vital role, you will lead a team of analytical scientists responsible for developing, transferring, validating, and implementing analytical methods to support late-phase oligonucleotide programs through commercialization. As the Attribute Sciences Team Lead (ASTL), you will provide scientific, technical, and strategic leadership, driving the development and application of analytical tools to characterize critical quality attributes and advance product and process understanding. You will leverage platform expertise and deep product attribute knowledge to shape analytical control strategies and enable successful process performance qualification (PPQ), regulatory submissions, marketing authorization, and commercial launch. In close collaboration with Process Development, Manufacturing, Quality, Regulatory, and external partners, you will influence cross-functional decisions, resolve complex technical challenges, and ensure successful execution of commercialization strategies.

- Lead and mentor a group of analysts in supporting process development. Provide career development guidance to the team members.
- Lead analytical method development for synthetic small molecules, synthetic peptide, and/or SiRNA manufacturing, release testing and characterization.
- Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
- Define analytical control strategies and implement methodologies for development of late phase clinical programs.
- Provide concise summary to cross-functional leadership for endorsement of key decisions.
- Oversee activities at contract manufacturing and testing sites.
- Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Address analytical and product quality inquiries from health authorities.

**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:**

Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience

OR

Masters degree and 5 years of Scientific experience

OR

Bachelors degree and 7 years of Scientific experience

**Preferred Qualifications:**

- PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
- Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for small molecule, peptide, and/or oligonucleotide drug substances and products.
- Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
- Strong understanding of peptide and/or oligonucleotide structural elucidation and characteristics that relate to quality of peptide and/or oligonucleotide.
- Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
- Strong experience in oligonucleotide method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
- Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
- Excellent communication skills and ability to provide concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
- Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
- Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents

**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.

Associate Mfg. Systems Engineer 1 (Automation Technician) Night Shift 12 Hours (6PM to 6AM)

**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.

Automation Maintenance Technician (6PM to 6AM)

**What you will do**

Lets do this. Lets change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery, and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps drive scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

Based in New Albany, Ohio, the site of Amgens new advanced product assembly and packaging plant. In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

The work schedule for this role will be a first shift schedule (Monday through Friday, approximately 6:30 am to 3:00 pm) for 1-2 months and then move to a 12 hour PM 2-2-3 shift schedule. As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across Amgens 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.

**Responsibilities:**

- Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies. Investigate complex issues or problems through the mentorship of experienced staff.
- Use PLC and HMI software tools to diagnose and troubleshoot complex, automated manufacturing equipment and systems.
- Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
- Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
- Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
- Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
- Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&IDs.
- Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.

**What we expect of you**

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

**Basic Qualifications:**

Bachelors degree

Or

Associates degree and 4 years of Technical Engineering experience

Or

High school diploma / GED and 6 years of Technical Engineering experience

**Preferred Qualifications:**

- Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
- Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
- SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
- Other Automated Control Systems to be supported are: Siemens and Rockwell HMIs, Cognex Vision System, Sensor and Systech Serialization
- Experience with automation system hardware and software support, including installation
- Excellent organizational, project management, problem solving and technical writing capability
- Strong communication: verbal / written, collaboration, influencing and facilitation
- MS Office: Word, Excel, Power Point

**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.

Ohio

Process Development Senior 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 Senior Scientist**.

**What you will do**

Lets do this. Lets change the world. In this vital role you will join our Drug Substance Technologies - Synthetics (DSTS) group at either our Thousand Oaks, California or Cambridge, Massachusetts campus. In this dynamic role, the individual will drive innovative solutions to support manufacturing of therapeutic peptides at various stages of development; pre-IND through commercial production. The successful candidate will have a strong background and experience in industrialization of solid phase peptide synthesis, ideally complemented with experience in peptide purification, isolation, and characterization techniques. The individual will be highly motivated and team-oriented with a proven track record of scientific innovation and achievement.

**Responsibilities:**

- Work effectively with a diverse team of synthetic chemists, chemical engineers and analytical chemists to develop scalable synthetic processes utilizing solid phase peptide synthesis
- Drive technology innovation in solid-phase synthesis, purification, and characterization of synthetic peptides
- Support cGMP manufacturing and technology transfer to external contract manufacturers
- Advance enabling technologies to accelerate pharmaceutical development and to improve sustainability and process efficiency
- Ensure process performance through process understanding, modeling and characterization
- Contribute to drug substance development teams by providing experimental results, technical updates, documentation, data interpretation, recommendations, etc.
- Work cross-functionally to deliver regulatory documents and support regulatory filings
- Serve as a technical expert and keep current in the field of solid phase peptide synthesis
- Work independently in advancing projects and studies within required deadlines.

**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 PhD OR PharmD OR MD \[and relevant post-doc where applicable\]

OR

Masters degree and 3 years of scientific experience

OR

Bachelors degree and 5 years of scientific experience

**Preferred Qualifications:**

- Ph.D. in organic chemistry, biochemistry, or chemical engineering with expertise in synthetic peptide process development
- Extensive hands-on expertise in the synthesis and purification of synthetic peptides produced by solid phase synthesis
- Experience within the pharmaceutical/biotech industry developing solid phase peptide synthesis processes and scaling/transferring the process into GMP manufacturing
- Proficiency in analytical characterization techniques such as Hydrophobic Interaction Chromatography (HIC)-HPLC, Size Exclusion Chromatography (SEC), Liquid ChromatographyMass Spectrometry (LC-MS), Ion-Exchange (IEX), and Reversed Phase (RP)-HPLC.
- Familiarity with laboratory automation, data analysis and visualization techniques and tools
- Track record of peer-reviewed publications and research presentations
- Demonstrated ability to work within a dynamic and interdisciplinary environment to achieve results
- Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects
- A research summary included with CV is strongly encouraged

**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.

Specialist Manufacturing Process Owner - Upstream / Downstream / Services

**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, 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 over10 million patientsworldwide. Come do your bestworkalongside 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 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.

**Specialist Manufacturing Process Owner - Upstream / Downstream / Services (Multiple Positions)**

**Live**

**What You Will Do**

In this vital role, you will serve as a Process Owner within the Manufacturing Support organization atAmgenNorth Carolina (ANC). The Process Owner serves as a technical process steward and key interface between Manufacturing Operations and support organizations. This roleis responsible forsupporting manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initiatives.

This position may support one of the following manufacturing areas depending on business needs and organizational assignment: Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

- Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.

- Provide manufacturing floor support, troubleshootingassistance, andhypercareduring routine manufacturing operations, process changes, startup activities, and first-time executions.

- Support operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testingsupport.

- Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.

- Monitor process performance andidentifyopportunities for process optimization, operational improvement, and risk reduction.

- Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.

- Author, revise, review, andmaintainmanufacturing SOPs, forms, and other GMP documentation.

- Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.

- Provide technical input to manufacturing risk assessments and support identification and mitigation of process, equipment, procedural, and operational risks.

- Participate in root cause analysis (RCA) activities and provide technical processexpertiseto support manufacturing investigations, major deviations, and quality events.

- Support CAPA applicability assessments, CAPA implementation activities, and CAPA effectiveness checks.

- Partner with Process Development to support process overviews, knowledge transfer activities, and facility fit assessments.

- Partner with Supply Chain, Manufacturing, and Engineering to support material readiness and Bill of Material (BOM) alignment, including single-use assemblies and consumables.

- Support MES and EBR activities by providing processexpertiseand manufacturing representation.

- Participate ininspectionreadiness activities and support audits asrequired.

- Appropriately escalate process, operational, quality, and compliance concerns.

**Win**

**What We Expect of You**

**Basic Qualifications**

- Doctorate degree and 2 years of biotechnology operations experience OR

- Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience OR

- Bachelor's degree and 6 years of biotechnology operations experience OR

- Associate's degree and 10 years of biotechnology operations experience OR

- High school diploma / GED and 12 years of biotechnology operations experience

**Preferred Qualifications**

- Technicalexpertisein Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

- Strong technical knowledge of drug substance manufacturing processes, equipment, and unit operations.

- Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.

- Experience supporting manufacturing floor operations, troubleshooting, andhypercareactivities.

- Experience supporting operational readiness activities including water runs, dry runs, equipment testing, and startup support.

- Experience authoring and maintaining GMP documentation including SOPs and manufacturing procedures.

- Experience supporting manufacturing change controls and implementation activities.

- Experienceparticipatingin risk assessments, root cause analyses, investigations, and CAPA implementation activities.

- Experience supporting CAPA applicability assessments and effectiveness checks.

- Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment.

- Knowledge of single-use technologies and Bill of Material (BOM) structures.

- Strong technical writing, communication, problem-solving, and organizational skills.

**Thrive**

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 through comprehensive benefits, career development opportunities, and a collaborative culture.

Senior Manager Manufacturing Programs- Process Owner Organization

**HOW MIGHT YOU DEFY IMAGINATION?**

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

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 single use 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.

**Senior Manager Manufacturing Programs**

**Live**

**What you will do**

We are seeking a Senior Manager ofManufacturing Programsto lead the Process Owner organization within Manufacturing Support at ANC. This leadership role is responsible for providing technical process stewardship, manufacturing support, process governance, and manufacturing changecontrolsupport for Upstream, Downstream, and Services Drug Substance Unit Operations.

The Process Ownerteamserves as the technical process steward for manufacturing operations, partnering closely with Manufacturing Operations and cross-functional support functions to ensure manufacturing processes are effectively governed, implemented, maintained, and continuously improved throughout their lifecycle.

Process Owners serve as the primary technical liaisons between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, Commissioning & Qualification (C&Q), Supply Chain, and Digital Manufacturing. Through floor presence,hypercaresupport, process ownership, operational readiness activities, and manufacturing change implementation, the team enables reliable, compliant, and efficient manufacturing execution.

The Senior Manager will lead a growing organization of Process Owners responsible for process ownership, floor support andhypercareactivities, operational readiness assessments, dry and water run execution, electronic batch record implementation support, manufacturing change implementation, BOM support, and procedural governance. This role will also be responsible for expanding organizational capabilities, including establishing and leading a swing-shift Process Owner team to provide enhanced operational support and manufacturing coverage.

**What You Will Do**

- Lead and develop the Process Owner organization responsible for providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.

- Provide direct management, coaching, mentoring, and career development for Process Owners.

- Develop and implement a swing-shift Process Owner organization to provide expanded manufacturing support and floor coverage.

- Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.

- Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation,manufacturing procedures, manufacturing CAPAs,and technical process stewardship.

- Coordinate with site scheduling to ensure Process Owners provide timely hyper-care support and technical assistance during manufacturing campaigns, startup activities, process changes, first-time executions, and routine operations.

- Serve as the primary interface between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.

- Oversee execution of dry runs, water runs, engineering runs, and operational readiness activitiessupporting manufacturing.

- Own manufacturing-relatedCAPAs andchange controls associated with process, procedural, and operational improvements.

- Provide leadership andinputfor electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.

- Partner withTechnologyteams to ensure manufacturing processes are effectively translated into digital workflows and manufacturing execution platforms.

- Partner with Supply Chain organizations to ensure manufacturing processes, material strategies, and Bill of Materials(BOM) support efficient manufacturing execution.

- Provide process ownership oversight for BOM creation, maintenance, and updates associated with manufacturing process changes.

- Ensure creation, revision, maintenance, and periodic review of GMP documentation supporting manufacturing operations.

- Drive strategic initiatives to improve process reliability, manufacturing efficiency, operator experience, and operational performance.

- Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections as required.

**Win**

**What We ExpectofYou**

**Basic Qualifications:**

Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience

OR

Masters degree and 6 years of biotechnology or pharmaceutical industry experience

OR

Bachelors degree and 8 years of biotechnology or pharmaceutical industry experience

OR

Associates degree and 10 years of biotechnology or pharmaceutical industry experience

OR

High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- 8+ years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.

- Prior people leadership experience managing and developing technical teams.

- Strong understanding of GMP manufacturing operations supporting Upstream, Downstream, and Services Drug Substance Unit Operations.

- Experience with process ownership, manufacturing support, and technical process stewardship.

- Experience supporting digital manufacturing systems, electronic batch records (EBRs), manufacturing execution systems (MES), and associated process implementation activities within a GMP manufacturing environment.

- Experience authoring, approving, and governing manufacturing SOPs and GMP documentationwithinQuality Systems (i.e. Veeva,Documentum, etc.).

- Experience leading manufacturingCAPAs/change controls and implementation activities.

- Experience supporting operational readiness activities, including dry runs, water runs, process implementation, and startup support.

- Experience partnering with Supply Chain organizations to support BOM management, material readiness, and manufacturing execution.

- Excellent organizational, written, verbal communication, and cross-functional leadership skills.

Sr. Data Scientist - Process Modeling

**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.Data Scientist - Process Modeling**

**What you will do**

Lets do this. Lets change the world. In this vital role you will join the Digital Process and Systems Analysis group within Process Development plays a key role in providing data infrastructure, platforms, and analytics to support engineering teams across our network, ensuring state-of-the-art data insights to drive innovation and efficiency for the commercialization and optimization of Amgens pipeline. This group also supports key priorities and the development of strategies for digital process development for both biologic and synthetic moieties.

This position is part of a team advancing biologics drug-substance modeling and the digitization of tech-transfer workflows. As new modeling capabilities are developed and information is parameterized, opportunities abound to deploy modeling tools to enable early insights and phase-appropriate decision-making. These capabilities support drug substance development, technology transfer, manufacture, and life-cycle management across Amgens global network of manufacturing and development sites.

This role will contribute to the success of Drug Substance Technology organization by helping to digitize workflows to drive improvements in technology transfer timelines and ensure right-first-time success. As a Sr. Data Scientist, you will evaluate and improve Amgens digital assets, collaborating as part of a multi-disciplinary team of scientists and engineers on a wide range of problems. The position will lead to solutions for open-ended no single right answer challenges, including modeling, data pipelines, and visualizations to support drug substance development, tech transfer, and manufacturing. The Sr. Data Scientist will also be responsible for determining, defining, and tracking performance improvements.

**Responsibilities**:

- Leverage tech-transfer and process-modeling domain knowledge to drive implementation of digital technologies
- Digital Product Ownership of tech-transfer digital applications, focused initially on expansion of digital process-modeling for the DS network
- Change management to integrate tech transfer digital applications into product teams
- Development of data products to enable FAIR data for tech transfer/NPI
- Enable AI Agentic workflows for DST modeling assets
- Collaborate with digital product teams to build and integrate modeling assets into business processes for DST
- Interact cross-functionally with a wide variety of people and teams. Work closely with engineers to identify opportunities for process design improvements for Amgen products
- Make business recommendations (cost-benefit, forecasting, scenario analysis) with effective presentation of findings to varied levels of stakeholders
- Contribute to establishing a robust data science strategy by providing recommendations related to process monitoring, data engineering, analytic platforms, analysis plans, and other relevant areas of data science

**What we expect of you**

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

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of Data Science or Engineering experience

OR

Bachelors degree and 4 years of Data Science or Engineering experience

OR

Associates degree and 8 years of Data Science or Engineering experience

OR

High School diploma or GED and 10 years of Data Science or Engineering experience

**Preferred Qualifications:**

- MS degree or doctorate in an engineering or scientific field with demonstrated capability in application of data science.
- Chemical Engineering modeling, drug-substance, tech-transfer experience
- 3+ years of work experience in biotechnology role (e.g. process engineer, scientist, data scientist)
- Experience with AGILE software development methodologies
- Experience with Databricks, coding languages (Python, SQL), AI Tools (Chat GPT, Codex, GenieCode), React, and BI tools (Spotfire/Tableau/Power BI)
- Experience in developing AI applications for process development workflows and integrating AI solutions into process development business processes
- Experience with process modeling for cell-culture, harvest,and purification scale-up
- Demonstrated performance in application of digital tools to solve analytical problems
- Demonstrated effective written and verbal communication skills
- Demonstrated leadership and self-direction. Demonstrated willingness to both teach others and learn new techniques as well as manage team members and deliverables.

**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 Principal 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 Principal Scientist**

**What you will do**

Lets do this. Lets change the world. In this vital role you will joining Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines (oligonucleotides and small molecules).

In this vital role as an Attribute Sciences team lead and group lead you will work to provide strategic analytical leadership to teams developingcommercialmanufacturing processes for synthetic and hybrid molecules and collaborate closely with Drug Substance, Drug Product and Product Quality colleague

- Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross-functionally within a Product development team
- Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization
- Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites
- Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
- Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
- Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development
- Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
- Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies
- Recognized as a scientific resource in area of expertisewho can provide mentorship to junior staff.

**What we expect of you**

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

**Basic Qualifications:**

Doctorate degree PhD OR PharmD OR MD \[and relevant post-doc where applicable\] and 3 years of \[Job Codes Discipline and/or Sub-Discipline\] experience

OR

Masters degree and 6 years of Scientific experience

OR

Bachelors degree and 8 years of Scientific experience

**Preferred Qualifications:**

- PhD with 3+ plus years of industry experience.
- Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and process control, structure elucidation and solid-state characterization
- Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development.
- Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner
- Hands on experience in development, validation, transfer and remediation of methods for in-process, release and stability testing
- Knowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development.
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations
- Ability to multitask managing deliverables on complex projects against timelines
- Strong leadership, problem solving, decision making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver results
- Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

**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.

Senior Process Engineer - Solution Prep, Upstream, and Downstream

**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. 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.

**SeniorProcessEngineer-Solution Prep,Upstream,andDownstream**

**What youwill do**

In this vital role you will 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 onSolution Prep,Upstream,andDownstreamProcess engineering and plant equipment.

**Site design, construction, start-up, and operational readiness:**

- Support thedesign andbuildof manufacturingequipmentsystems byaligningdesign reviewprocessesand documentswith site requirements, including equipment design and sizing, architecture and electricaldistribution, and piping and instrumentation diagrams.

- Supportfactoryacceptancetestingworking in partnershipwith global engineeringduringsiteinstallation,including reviewing protocolsandresolving punch list items.

- Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply withpertinent environmental health/safety practice,rulesand regulationsas well as Amgen global engineering requirements.Ensurethat systems are installed per the designrequirements.

- Executeand guidethe commissioning and validationof systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulationand on-time project delivery.Supportexecution of engineering and performance qualification runswhile providinghypercaresupport as needed.

- Perform engineering assessmentsfor plant equipment operations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions asrequired.

**Site Operations:**

- Responsible system ownerforSolution Prep,Upstream,andDownstreamDrug substanceprocess equipment, areas, and systems providingend-to-endsupport for operations.

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

- Work with original equipment manufacturers for breakdown and planned maintenance ofprocess equipmentas applicable.

- Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvements,identifyingdesign requirements, and translating these requirements intoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment.

- Developmastermaintenance programsfor equipment, ensure the availability of spare parts, andcoordinate maintenance activities to ensure systems are in proper working order.

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

- Providetechnical masteryandproblem-solvingleadershiptoproactivelyreduce production downtime. Thisincludes leadingtechnical root cause analysis and implementation of corrective/preventiveactions for families of systems.

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

- Provide rotational on-call support and/or shift support based on business needs to ensure24x7 day-to-dayreliability of Solution Prep, Upstream and Downstream systemsfor plant operations.

- On-site and up to10% domestic/international travel.

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Mastersdegree and 2 years of Engineering experience

OR

Bachelorsdegree and4years ofEngineeringexperience

OR

Associatesdegree and8years ofEngineeringexperience

OR

High school diploma / GED and10years ofEngineeringexperience

**Preferred Qualifications:**

- Degree in Chemical or Mechanical Engineeringor similar engineering discipline.

- 6+years'of relevant work experience with 5+ years' experience in Biopharmaceuticaloperations/manufacturing environment

- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Productionfacility equipment/systemswith direct experience withSolution Prep,Upstream,andDownstreampurification equipment suchasweigh and dispense equipment, solution preparation vessels,cell culture reactors, centrifugation, chromatography,viralfiltration skids,andUFDFskidsas well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.

- Experience with Tech Transfer, Process Design, and Commissioning & Qualification.

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

- Understanding ofsafety requirements working in a GMP Biopharmaceuticalproductionfacility.

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

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

- Work schedule flexibility asrequiredto support 24/7 operations.

- Ability for domestic/international travel.

**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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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 Engineer - Solution Prep, Upstream, and Downstream

**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. 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.

**ProcessEngineer-Solution Prep,Upstream, andDownstream**

**What youwill do**

In this vital role you will 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 as well as developing domain expertise tosupport operations upon start-up.

**Site design, construction, start-up, and operational readiness:**

- Support the commissioning and qualification ofmanufacturingsystems in alignment with GMP requirements and interact with regulatory inspectors.

- Ensuresystemsare installed andoperatesafelyandcomply withpertinent environmental health/safetypractice,rulesand regulations.

- Support commissioning and qualification of systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulations.

- Interact with regulatory inspectorsas a manufacturing systems owner to communicate anddemonstrateappropriate regulatorycomplianceofoperating systems.

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

**Site Operations:**

- Provide systemsupportforbiopharmaceutical process equipment.Assistinidentifyingand implementing engineering-based improvements or upgrades to equipment or facility systems.

- Support the developmentofbusiness cases for improvements,identification ofdesign requirements, and translation ofthese requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation ofimprovements.

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

- Providesystem guidance toidentifyperformance risks and implement risk reduction strategies.

- Provideproblem solving support to reduce production downtime. Thisincludessupporting technical root cause analysis and implementation of corrective/preventiveaction.

- Provide rotational on-call supportand/or shift supportbased on business needstoensure24x7 day-to-dayreliability ofSolution Prep,Upstream and Downstream systemsfor plant operations.

- On-site and up to10% domestic/international travel.

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

**Basic Qualifications:**

Masters degree

OR

Bachelorsdegree and 2 years ofEngineeringexperience

OR

Associatesdegree and 6 years ofEngineeringexperience

OR

High school diploma / GED and 8 years ofEngineeringexperience

**Preferred Qualifications:**

- Bachelors degree in Chemical or Mechanical Engineeringor similarengineerdiscipline.

- 3+years'of relevant work experience with2+ years' experience in Biopharmaceuticaloperations/manufacturing environment

- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids 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 scientificmanner using data-driven techniques and analyses (e.g., Data Analytics, Root CauseAnalysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

- Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.) andfamiliarity 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 systemmodifications, introduction of new processes, and the oversight of capital projects

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

- Understanding ofsafety requirements working in a GMP Biopharmaceutical Productionfacility.

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

- Collaborativeteammateprepared to work in and embrace ateam basedenvironment thatrelies on communication for effective decision-making

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

- Work schedule flexibility asrequiredto support 24/7 operations, requiring occasionalafterhoursengineering coverage

- Ability for domestic/international travel.

**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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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 Analytical 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. 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.

**ProcessAnalyticalEngineer**

**What youwill do**

In this vital role, you will join the Facilities & Engineering (F&E) group andbe responsible forplanning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina (ANC). This role includes hands-on troubleshooting and root cause analysis for analytical and laboratory systems, coordination of vendor support and repairs, execution and tracking of calibration, maintenance, and requalification activities through the Computerized Maintenance Management System (CMMS) Maximo, and direct support for manufacturing operations to improve equipment uptime and reliability. You will also author, own, and approve Validation Life Cycle documents for computer-related systems, including responsibility for Data Integrity testing and business administration of laboratory computer-related systems.

- Support commissioning, qualification, validation, and system lifecycle documentation tomaintaincompliance and operational readiness.

- Partner closely with manufacturing teams to resolve issues, improve system reliability, and minimize operational downtime.

**Key responsibilities:**

- **System ownership, reliability, and operations**

- Work with the capital project team to ensure systems are installed andoperatesafely,comply withpertinent environmental health and safety practices, rules, and regulations, and meet Amgen global engineering and design requirements.

- Serve asSystemOwner and Business Administrator foranalyticalequipment.

- Lead or work with teams in design, development andselectionof new systems, instruments, calibrationcapabilitiesand consumable components.

- Development of laboratory equipment specifications touse for procurement of new laboratory equipment and instruments.

- Maintaining a current working knowledgeregardingregulatory requirements for equipment qualification and calibration.

- Support in generation and resolution of protocol discrepancies asrequired.

- Alerting Quality Control Management if equipmentfails tomeet calibration or qualification requirements and conducting impact assessments/investigations asrequired.

- Lead the development of calibration/maintenance programs, ensure the availability of spare parts, schedule repairs and maintenance, and coordinate maintenance execution to keep systems in proper working order and minimize disruption to laboratory activities.

- Participation in technical project teams to function as a subject matter expert on instrument validation regulations and procedures.

- Evaluatethe capabilitiesof current and potential suppliers, and assessnew technologiesthat could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.

- Writing/contributing to equipment operating procedures and manuals.

- Designing and conducting training formanufacturingstaff, and other department staff as applicable.

- Own and project manage change controls while meeting applicable change control metrics.

- Preparing and presenting periodic management updates on activities to senior management.

- Conduct periodic reviews of instrument validation as part of validation life cycle.

- **Validation, compliance, and quality systems**

- A key contributor to Data Integrity Assessments for Lab systems

- Support Amgens laboratory systems validation and Data Integrity philosophy during audit interactions.

- Supportadditionaltasks andprojects asassigned by management.

- **Cross-functional support, projects, and continuous improvement**

- Develop, coordinate, analyze, and present results for operational issues and engineering projects

- Provide technical supportforcommercial and clinical manufacturing as needed.

- Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.

- Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.

- Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and support interactions with regulatoryinspectorsas necessary.

- Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.

- Monitor systems toidentifyperformance risks and implement risk reduction strategies.

- Provide troubleshooting support to reduce production downtime, including leading and/or supporting technical root cause analysis and implementation ofcorrective/preventive action; support may berequiredoutside of normal working hours, including nights, weekends, and holidays.

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

- Advance the use of condition-based and predictive maintenance practices by incorporating advanced data analytics where applicable.

- Lead investigations of abnormal conditions through Deviation and related business processes.

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

**Basic Qualifications:**

- Masters degree

OR

- Bachelors degree and2years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience

OR

- Associates degree and6years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience

OR

- High school diploma / GED and8years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience

**Preferred Qualifications:**

- Bachelors degree in engineering or related technical field

- Laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.

- Knowledge of themethodologyand instrumentation and analytical techniques used for biopharmaceutical testing.

- Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.

- Demonstrated success in managing an equipment qualification or maintenance program.

- Ability to provide On-Callsupportcoveragenights and weekends, on a rotating basis.

- Position requires strong written and verbal skills and the ability to work withminimumdirection.

- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.

- Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.

- Ability to function within cross-functional teams and embrace a team-based environment.

- Work schedule flexibility asrequiredto support 24/7 operations.

- Ability for domestic/international travel.

**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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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.

Manufacturing SystemsEngineer:Automation- DeltaV (Swing Shift Monday- Friday)

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,wevehelped 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,youllhelp 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 thatliewithin them,youllthrive 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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 SystemsEngineer:Automation - DeltaV**

**What you will do**

Letsdo this.Letschange the world.As aManufacturing SystemsEngineer,you willwork with agroup ofautomationengineers whoare responsibleforbuildingandmaintainingvarious automation systems and platforms that support the GMP DrugSubstancePlant Operations.

**\*The schedule for this position willbe:SwingShift3pm - 11pm: MondaythroughFriday.\***

In this vital roleas a member of the Facilities & Engineering (F&E) Automationteamyou will work hand in hand with the capital project team to deliver robustprocess automation systemstooperatethe new plant.

Responsibilities:

- Develop andmaintainthe process control system on EmersonDeltaVdistributed control system (DCS).

- Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems.

- Provide clear documentation for delivered solutions andprocesses.

- Support QA partners in performing computerized systems validation in aGxPenvironment.

- Perform Data Integrity Assessments (DIA)in accordance withthe current Amgen and industry standards.

- Supportprocess automationsystemsto ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.

- Support vendor FAT to ensure that control strategy and software code meet Amgen requirements.

- Develop andmaintainengineering and maintenance documentation, and associated procedures for delivered solutions and processes.

- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.

- **Site Operations**

- Own and drivetocompletionChange Controls, CAPAs, and Deviations.

- Supporttechnical root cause analysis, incident investigations, and troubleshooting.

- Support functional area projects focused on improving process equipment,utilities,andfacilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility.

- Drive continuous improvement forprocess automation systemsto improve operational workflows, safety, reliability, efficiency, and sustainability.

- Supportday-to-dayoperationsincluding rotational on-callsupport.

- Prepare/review Standard Operating Procedures (SOP) and cGMP documents.

- Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

**What we expectfromyou**

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications.

**Basic Qualifications**

- High School Diploma / GED and 8 years of Engineering experience OR

- Associates Degreeand 6 years of Engineering experience OR

- Bachelors Degree and 2 years of Engineering experience OR

- Masters Degree

**Preferred Qualifications**

- Degree in Electrical Engineering,Computer Science, Chemical Engineering,Biotech Engineering,or relatedfield.

- Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors,solution prep,single use mixingvessels,chromatography,TFFL/TFFX,viral filtration, viral inactivation,UF/DF,depth filtration, drug substance fill,CIP/SIP, clean utilities,and integrating various OEM automation software.

- Experienceinprogramming,installation,and lifecycle management of automation and field instrumentation technologies.

- Experiencein programming, design, installation and lifecycle management of manufacturing process controls,andautomation and field instrumentation technologies.

- Experience with EmersonDeltaVDCS systemandability to perform advanced troubleshooting,and systemintegration using OPC, Foundation Fieldbus,andProfibustechnologies.

- Ability to interpret and apply GAMPs and GMPs,and familiarity with documentation in a highly regulated environmentwith requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95.

- Self-directed team playerable to work cross-functionally.

- Strong technical writing and communicationskills.

**What you can expect from 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.From our competitive benefits to our collaborative culture,wellsupport your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan based on eligibility 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 and bi-annual company-wide shutdowns

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

**Apply nowfor a career that defies imagination**

In our quest to serve patientsabove all else, Amgen is the first to imagine and the last to doubt. Join us.

careers.amgen.com

\#AmgenNorthCarolina

Senior Manufacturing Systems Engineer:Automation- DeltaV(Swing Shift Monday - Friday)

ANC1 F&E Engineering

**HOW MIGHT YOU DEFY IMAGINATION?**

If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

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 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.

**Senior Manufacturing Systems Engineer:Automation- DeltaV**

**Live**

**What you will do**

Letsdo this.Letschange the world.AsaSeniorManufacturing SystemsEngineer,you will provideautomationtechnical leadership to a group ofautomationengineerswhoare responsible forbuilding andmaintainingvarious automation systems and platforms that support the GMP DrugSubstancePlant Operations.

**\*The schedulefor this position willbe:SwingShift3pm - 11pm: MondaythroughFriday.\***

In this vital roleas a member of the Facilities & Engineering (F&E) Automationteamyou will work hand in hand with the capital project team to deliver robustprocessautomation systems tooperatethe new plant. This includes complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecyclemanagementand Operational Excellence.

Responsibilities:

- Develop andmaintainthe process control system onEmersonDeltaVdistributed controlsystem(DCS).

- Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.

- Collaborate with business partners to understandhowautomationcan improve workflow and productivity.Synthesize requirements from clients,customersor end-users to develop the best automation solutions.

- Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in aGxPenvironment.Maintain Data Integrity Assessments with the current Amgen and Industry standards.

- Build the business processes to support theprojectscope in alignment with project timelines. Develop detailedspecificationand engineering policies and procedures that affect multiple organizational units.

- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.

- On-going operations:

- Own and drive tocompletionChange Controls, CAPAs, and Deviations.

- Lead and support functional area projects focused on improving processequipment/utilities/facilitiesas well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.

- Leadandsupport technical root cause analysis, incident investigations, andtroubleshooting onprocess control issues related to plant operations.

- Lead and support new product introductions (NPI) ornew technologyintroductions by performingautomationengineering assessments, implementingautomationsystem configurationchanges,and supporting engineering and process qualification runs as applicable.

- Manage Day-to-day Operational Support including:24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations,Process andUtilityAutomatonsystems,Preventive andCorrectiveMaintenance,SystemAdministration,andAutomation Systemspare parts management.

- Prepare/review Standard Operating Procedures (SOP) and cGMP documents.

- Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications.

**Basic Qualifications:**

- High School Diploma / GED and10years of Engineering experience OR

- Associates Degreeand8years of Engineering experience OR

- Bachelors Degree and4years of Engineering experience OR

- MastersDegree and2years of Engineering experience OR

- DoctorateDegree

**Preferred Qualifications:**

- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or relatedfield.

- Direct knowledge of Automation System design, experience inprocess control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automationsuch asmedia, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.

- Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,automationand field instrumentation technologies.

- Experience with EmersonDeltaVDCS system, Process Control Network design including network segregation,virtualinfrastructure design and implementation,and ability to perform advanced troubleshooting activities,systemintegration using OPC, Foundation Fieldbus, Profibus, andDeviceNettechnologies.Experience withDeltaVLive is preferred.

- Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environmentwith requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.

- Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.

- Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.

- Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g.cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.

- The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.

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

**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**

In our quest to serve patientsabove all else, Amgen is the first to imagine, and the last to doubt. Join us.

**careers.amgen.com**

**#AmgenNorthCarolina**

Associate Director Process Development

**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. 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 Director, Commercial Drug Products & Life Cycle Management**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be part of Amgens Process Development organization, Drug Product Technologies unit that continuously strives to be a technical leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team leaders (DPTLs) play a central role in this process by serving as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation, integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an integrated operations team and lead a technical team responsible for delivering drug product process transfers, process optimization, process trouble shooting, timely closure of non-conformance investigations and change control assessments to ensure supply of commercial drug products. We are seeking an Associate Director to lead commercial drug product programs as DPTL and lead a scientific team that supports advancing the commercial drug product programs in our portfolio.

- Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of parenteral and/or oral solid dosage presentations.
- Lead a team of scientists focused on late-stage drug product process development and tech transfer and coach staff with emphasis on people-centered leadership.
- Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
- Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
- Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
- Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
- Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
- Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
- Ability to travel domestically and internationally up to 10% of the time.

**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:**

Doctorate degree and 3 years of experience in engineering or science **OR**

Masters degree and 7 years of experience in engineering or science **OR**

Bachelors degree and 9 years of experience in engineering or science **OR**

Associates degree and 12 years of experience in engineering or science **OR**

High school diploma / GED and 14 years of experience in engineering or science

**And**

In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- PhD from an accredited college or university in one of the following areas Biotechnology, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
- 8+ years of pharmaceutical development and management experience
- 8+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization
- Demonstrated knowledge of drug product commercialization and integrated combination product development with hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
- Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
- Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
- Strong knowledge about developing processes with single-use manufacturing equipment
- Aseptic processing experience and familiarity with cGMPs, ICH guidelines
- Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Strong problem solving and effective cross-functional communication skills
- Proven ability to learn and act on dynamic information at a rapid pace
- Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment to lead change, efficiency, and strong cross functional relationships

**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.

Senior Manager Manufacturing Systems Engineering - Automation (Multiple Positions)

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,wevehelped 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,youllhelp 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 thatliewithin them,youllthrive 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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.

We are hiring **two Senior Manager, Manufacturing Systems Engineering** positions, each with a distinct area of focus:

- **Senior Manager Automation Systems:**  Responsible for leading and supporting **Building Automation Systems (BAS/QBAS), Rockwell PLC platforms, Upstream Process Control Systems (PCS), and Clean Utility PCS**.
- **Senior Manager Manufacturing & Project Delivery:**  Responsible for **New Product Introduction (NPI) delivery, project implementation, manufacturing shift floor support, and Downstream Process Control Systems (PCS)** .

Indicate area of interest and relevant experience as it aligns with one or both of these leadership opportunities.

**Senior Manager Manufacturing Systems Engineering - Automation**

**What You Will Do**

Letsdo this.Letschange the world. In this role The Senior Manageris responsible forproviding technical and administrative leadership to a group of Automation Engineers accountable for administrating andmaintainingautomation systems for Drug Substance manufacturing at AmgenNorth Carolina(ANC). Responsibilities include meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time. The Sr. Manager also ensures that the automation teamappliesthe Corporate Automation Business Processes and drivers to deliver the automation services to theorganization.

As part of the Facilities& Engineering (F&E) group, the Senior Manager will work with the Director of Engineering atAmgenNorth Carolina. This role is expected to provide leadership as follows:

- Lead a team of Automation Engineers and serve as the main point of contact for automation function forANC1manufacturing.Systems including Allen Bradley PLCs, SiemensDesigoCCforbuildingautomation, and EmersonDeltaVfor process control.

- Define, drive, and deliver the automation and process control strategy within Drug substance manufacturing.

- Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.

- Strategic and tactical management and leadership in providing 24x7 day-to-day operational support, mentoring, staff development, team productivity, and efficient use of available resources.

- Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives' execution.

- Providinput into departmentobjectivesandestablishingstrategic direction within the Drug Substance Network for the F&E automation team.

- Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership, and other technical staff in the network, focusing on Maintenance Excellence systems failures and recurrence avoidance.

- Work with diverse groups (Manufacturing, Quality, PD, Automation,Technology, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.

- Identifyareas of potential improvement, conduct analysis, recommend solutions, sponsor improvement projects, and implement.

- Ensure site readiness and compliance for internal audits, external agency audits, and partner audits.

- Ensure the safety of all personnel during plant operations and engineering activities.

- Develop expense budgetforecastand adhere to department budgets and spendforoperational and capital expenses, holding 100% accountability.

- Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

- Ensure Amgen Enterprise cyber resiliency compliance ismaintainedat 100%.

- Ensure the right processes/systems are in place to capture 100% quality compliance for the right-first-time(RFT) delivery of automation solutions.

- Ensure that reporting functionality is incorporated for all unit operations forproductionBatch records, cleaning, and sterilization systems, including Audit trail and version control.

- Responsible for ensuring that service contracts with all OEMs for systems areestablishedfor service and support needs, including service banked hours for specialized support needs.

- Ensure that all automation staff are adequately trained and follow all GMP standards and procedures by managing the team's internal and external training needs.

- Ensure the automation staff are fully aware and confident to work on all automation systems, process equipment, andfacilityto provide 24x7 reliable plant automation support.

- Responsible for ensuring that the automation team activelyparticipatesin daily/weeklyWork Center Team (WCT)meetings Manufacturing area& plant WCTs, Automation WCT, Automation leadership WCT, etc. to address day-to-day topics and discuss issues with multi-functional teams to resolve.

- Responsible for ensuring the automation team provides the required support to implement expense, department capital, construction, and GLAM-DTI projects.

- Provide active leadership such that proactive feedback issolicitedfrom the automation staff and actions are taken tomaintainproper work-life balance.

**What We ExpectOfYou**

We are all different, yet we all use our unique contributions to serve patients. The engineering management professional weseekwillpossessthese qualifications.

**Basic Qualifications:**

- High school diploma / GED and 12 years of Engineering and/or ProjectManagement experience OR

- Associates degree and 10 years of Engineering and/or Project Management experience OR

- Bachelors degree and 8 years of Engineering and/or Project Management experience OR

- Masters degree and 6 years of Engineering and/or Project Management experience OR

- Doctorate degree and 2 years of Engineering and/or Project Management experience

- Additionally: In addition to meeting at least one of the above requirements, you must have a minimum of 2years experiencedirectly managing people and/or leadership experience leading teams, projects, programs, or directing the allocationorresources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field

- Experience with EmersonDeltaVDCS system, SiemensDesigoCC, Allen BradleyPLCand ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies

- Direct knowledge of automation system design

- Experience in programming, installation and lifecycle management of automation and field instrumentation technologies

- Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography,single usemixing vessels, depth filtration, and solution prep

- Experience in integrating various OEM automation software

- Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.

- Fieldbus, and Profibus technologies

- Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95

- Self-directed team player able to work cross-functionally

- Strong leadership, technical writing, and communication skills

**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 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 nowfor 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.

Senior Electrical Engineer - Power Systems

**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. 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.

**Senior Electrical Engineer - Power Systems**

**What youwill do**

In this vital role you will be joining the Facilities & Engineering (F&E) groupandcollaborate withthe capitalprojects team to ensure projects meet the site standards and requirements. You will steer theprojectselectrical planning and design and support construction to ensure the projects are built and commissioned to Amgen standards.

**Site design, construction, start-up, and operational readiness:**

- Support thedesignand equipmentselectionfrom an electrical perspectiveof process, utilities, and building systems tooptimizequality and cost across the total life cycle of assets. Ensureappropriate useof technology, andalignmenttobest operation and maintenancestandards/practices

- Support factory acceptance testing working in partnership with global engineering during site installation, including reviewing protocols and resolving punch list items.

- Provide engineering support duringconstructionto the Capital Projects team, resolve technical issues, and ensure projectobjectivesare met.

- Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providinghypercaresupport as needed.

- Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions asrequired.

**Site Operations:**

- Responsiblefor Electrical engineeringexpertiseforprocess, utilities, and building systemsproviding end-to-end support for operations.

- Effectively collaborate with key customers and support groups to ensure reliable plant operations.

- Work with EHSS in support of electrically related safety initiatives, plans, and investigations.

- Leadidentifyingand implementingengineeringbasedimprovements or upgrades to process equipment systems. This may include developing business cases for improvements,identifyingdesign requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.

- Support delivery of capital projects with responsibilities for electrical design.

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

- 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 ofsystems, as well as the use of AI tools for troubleshooting and fault analysis.

- 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.

- Advance AI innovative solutions and technologies for implementation and to enable volume driven growth.

- Represent Amgen with outside firms, technicalsocietiesand regulatory bodies.

- Deploys engineeringexpertisefrom within the company (global and site-based authorities) as well asexpertisefrom our industry tooptimizeAmgens assets throughout their life cycle.

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

- Up to 10%domestic/international travel.

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients! TheSeniorEngineer professional weseekis a strong collaborative individual contributor leader with these qualifications:

**Basic Qualifications:**

- High school diploma / GED and 10 years of Engineering experience OR

- Associate degree and 8 years of Engineering experience OR

- Bachelors degree and 4 years of Engineering experience OR

- Master's degree and 2 years of Engineering experience OR

- Doctorate degree

**Preferred Qualifications:**

- **\*Professional registration, suchasaProfessional Engineer (PE) license.\***

- Strong leadership and collaboration skills, and the ability to approach technical issues with ascience basedmentality whileprovidingclear direction within the area of expertise.

- Familiarity and/or experience working in a regulated environment, pharmaceutical or biotechnology industries.

- Knowledge of regulations (e.g.cGMP, building codes, fire codes,electrical codes,IEE, NEC, NETA, insurance FM,OSHA, LEED, Energycodes)to ensure compliance.

- Experience in the design and constructionformedium voltage electrical distribution systems including switchgear,transformersand paralleling generators.

- Knowledge of design and construction for 600V (and below) electrical distribution systems equipment including switchgear, panelboards, lighting / lighting control, power monitoring, generators,Life Safety Systems,andLightning Protection Systems.

- Ability to provide direction and guidance to external design firms to deliver capital projects

- Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.

- Problem-solving skills to apply the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approaches.

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

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

- Work schedule flexibility asrequiredto support 24/7 operations.

- Ability for domestic/international travel.

**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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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.

GenScript

Automation Engineer

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

The position reports to the Director of US Molecular Biology R&D at the Piscataway site of the GenScript Gene R&D department.

**Responsibilities:**

1. Develop new automation workflows to meet the high throughput biomanufacturing needs.
2. Maintain and upgrade existing automation methods.
3. Provide hands-on support, troubleshooting, and maintenance for individual lab instruments and larger integrated automation systems.
4. Diagnose and resolve complex mechanical, software, and system integration issues to minimize equipment downtime and maintain operational continuity.
5. Manage project timeline and leverage internal resources to push project forward.
6. Closely communicate with other teams to ensure the smooth tech transfer.

**Qualifications**

1. Bachelor’s degree in mechanical engineering, biomedical engineering, and other related fields.
2. 1+ year of relevant experience of automation development in biomanufacturing environment.
3. Experience with laboratory instrumentation and automation systems.
4. Excellent communication and organization skills.
5. Experience troubleshooting liquid handling instruments such as Tecan Fluent, Hamilton STAR.
6. Extensive experience in writing scripts/protocols for Tecan, Hamilton, Thermo Momentum Scheduler.
7. Experience with molecular biology experiments is a plus not a must.

**Preferred Qualifications**

- Basic understanding of equipment communication, networking, TCP/IP, serial communication, or automation software is a plus.
- Basic programming or scripting experience is a plus.
- Experience in a biotechnology, pharmaceutical, laboratory, or regulated manufacturing environment is a plus.

**Benefit:**

- Medical Insurance/ Vision Insurance/ Dental Insurance
- 401(k) & Retirement Savings Plan (RSP)
- Short Term Disability Insurance
- New Child Leave
- Paid Time Off
- Paid Company Holidays per year
- Paid Sick Days (earned based on hours worked)
- Compassionate Leave
- Jury Duty Leave
- Float day
- Personal days

**Compensation:**

Salary range: $70,000 – $90,000, depending on experience and qualification

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.