Manufacturing & Production

Sanofi US

2027 Spring Co-op HSE, Swiftwater, PA

**Job Title:**  *2027 Spring Co-op HSE*

- **Grade:**  *Co-op*
- **Location:**  *Swiftwater, PA*
- **Duration:**  *6 months*

**About the Job**

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. We are seeking a highly motivated **Spring Co-op** to join our **HSE team**.

Ready to grow your skills while helping shape the future of healthcare? At Sanofi, youll be empowered to learn, ask questions, and bring your ideas to life all while supported by inspiring mentors and collaborative teams.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

- Program and training development, safety inspections, hazard evaluations, and risk assessments.
- Implementation of HSE cultural/behavioral programs.
- Process design reviews, industrial hygiene assessments, chemical inventory updates, and investigation of safety risk reports.

**About You**

**Basic Qualifications:**

- Currently pursuing a bachelor's or master's degree in Safety, Health, and Environmental Sciences or related field.
- Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the Internal requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.
- Must be enrolled in an accredited college or university throughout the duration of the co-op/internship.
- Must be able to relocate to the office location and work 40hrs/week, Monday to Friday for the full duration of the co-op/internship.

**Why Choose Us**

- Bring the miracles of science to life alongside a supportive, future focused team.
- Stretch your skills through apprenticeships, internships, graduate programs, and international experiences that grow with you.
- Learn from inspiring mentors and collaborative teams while contributing to real projects that shape the future of healthcare.
- Build your future with access to the latest tools, digital innovation, and continuous learning that keep you ahead of the curve.

**Compensation**

The salary range for this position is **$35 -$45 USD** hourly. All compensation will be determined commensurate with demonstrated experience.

\#LI-Onsite

\#vhd

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Pennsylvania

Siegfried

Entry Chemical Operator

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

SUMMARY:

The incumbent is responsible for operation of chemical manufacturing equipment and processes on a shift team to produce pharmaceutical bulk active ingredients and intermediates.

**Your Profile:**

**ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES**:

- Demonstrates full competency in the operation of all chemical production equipment, such as reactors, kettles, stills, filters, centrifuges, pumps, and demonstrates advanced understanding of chemical processes.
- Must be able to obtain and interpret information shown by instruments, such as temperature, pressure, vacuum, or flow indicators, recorders or controllers and make corrective adjustments as required on equipment, based upon information obtained.
- Must keep accurate Batch Log Record Sheets showing materials used, produced and pertinent operating information such as pressure, temperature, and vacuum. Accurately labels containers ie. drums, bottles.
- Performs simple analytical tests such as pH, foreign matter, Ash test, LOD, and Kf. Also be able to use the mobile EHS monitor (Draeger Tube) and obtains samples from batches or containers and submits these samples to supervisor or laboratory computerized log in system.
- Keeps other employees aware of changes in the immediate environment (ie. welding, construction, critical process steps.
- Immediately informs the Supervisor of deviations in the process and completes deviation forms as required.
- Carries out all work as instructed by the Supervisor, assists when investigations have to be conducted, and takes immediate action in case of emergencies.
- Disposes of wastes in a correct manner and is responsible for good housekeeping and cleanliness at workstation.
- Performs necessary equipment maintenance as needed to support and continue batch processing.
- Safely drives and handles fork and hand trucks in the plant.
- Assists with the validation / qualification of processes and equipment and proposes improvements to the processes and equipment.
- Aims at the highest possible productivity considering all relevant safety, environmental and quality (cGMP) regulations and guidelines. Knows and follows all relevant Standard Operating Procedures.
- Adheres to personal moral, ethical, legal, and behavioral conduct in compliance with the Siegfried Code of Conduct.
- All other duties as assigned.

**SUPERVISION:**

N/A

**EDUCATION and EXPERIENCE REQUIREMENTS:**

- HS Diploma or equivalent is required.
- Must be able to read and write legibly in English and perform mathematical calculations such as yield and scale-down batch ratios.
- Prior bulk pharmaceutical experience or batch chemical experience is required.

- Must be able to work accurately and according to written and verbal instructions.
- Must be able to work in a chemical manufacturing plant environment.
- Must be able to obtain respiratory clearance.
- Must also be clean shaven to wear a face respirator when required.
- Must be able to do heavy physical work and climb stairs. The heavy physical work consists of breaking and rolling drums that can weigh up to 400 lbs. Frequency: every shift

**ADDITIONAL SKILLS and QUALIFICATIONS:**

- Must be able to learn and operate computer controlled equipment.
- Having additional computer skills is a plus.
- Must be able to operate in-plant vehicles.
- Must be able to load kettles which requires the operator tips and lifts drums that weight up to 75 lbs. Frequency: every shift.
- Must be able to unloading centrifuges, which requires the operator to scrape cake off the cloth walls and scoop out the material that can weigh up to 5 lbs per scoop. Frequency every shift.
- Ability to stand for long periods of time.
- Able work in extreme temperatures, indoors when required to wear appropriate flame retardant uniform, coveralls or vapor barrier coveralls.
- Must be able to work overtime

Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.

\*\*\*THIS POSITION REQUIRES MEMBERSHIP INTO TEAMSTERS LOCAL 676\*\*\*

**Your Benefits:**

Starting rate $31.08/hr

\*Requires entry to Teamsters Union\*

No-Cost Health Insurance, Competitive Retirement (401k) Plan, Generous Paid Time Off

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

New Jersey

Utility Engineer

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

The incumbent is responsible for supporting, improving, and maintaining site utility systems across the Pennsville facility. The primary focus will be on ensuring safe, reliable, compliant, and efficient operation of critical utilities including, but not limited to, steam, condensate, chilled water, cooling water, plant air, nitrogen, purified water, wastewater, HVAC, and related infrastructure. This role works closely with Maintenance, Engineering, Operations, SHE, Quality, and external vendors to troubleshoot utility system issues, support capital and expense projects, improve system reliability, and ensure adherence to applicable cGMP, SHE, and engineering standards.

**Your Profile:**

**ESSENTIAL DUTIES, RESPONSIBILITIES, AND ACCOUNTABILITIES:**

- Provides engineering support for site utility systems including steam, condensate, chilled water, cooling water, plant air, nitrogen, purified water, wastewater, HVAC, and related distribution systems.
- Monitors utility system performance and identifies opportunities to improve reliability, efficiency, safety, and compliance.
- Supports troubleshooting of utility system failures, process interruptions, and recurring equipment issues.
- Develops and implements corrective and preventive actions to reduce utility-related downtime and operational risk.
- Reviews and optimizes preventive and predictive maintenance strategies for utility equipment and infrastructure.
- Supports capital and expense projects by providing utility engineering input on scope, design, equipment selection, installation, commissioning, and turnover.
- Reviews utility system drawings, P&IDs, specifications, equipment documentation, and maintenance records for accuracy and completeness.
- Assists with utility system capacity evaluations, risk assessments, and long-term infrastructure planning.
- Works with Maintenance and Operations to prioritize utility work, coordinate system outages, and support shutdown planning.
- Supports investigation of utility-related deviations, incidents, failures, and compliance concerns.
- Ensures utility systems are maintained in accordance with applicable cGMP, SHE, regulatory, and engineering standards.
- Supports change control, management of change, commissioning, qualification, and documentation activities as required.
- Coordinates with vendors, contractors, and service providers to support inspections, repairs, testing, and improvement projects.
- Identifies opportunities for energy reduction, water conservation, waste reduction, and utility cost improvement.
- Provides technical guidance and training to Maintenance, Operations, and other site personnel as needed.
- Assists in the implementation and optimization of CMMS data, work plans, spare parts, and equipment history for utility assets.
- Maintains close communication with site and corporate engineering teams regarding utility performance, project status, and improvement opportunities.

- Adheres to personal moral, ethical, legal, and behavioral conduct in compliance with the Siegfried Code of Conduct.
- Ensures implementation and adherence to all applicable SHE and cGMP regulations.

**EDUCATION AND EXPERIENCE:**

- BS Degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or related technical field.
- Minimum of 3–5 years of experience in utility engineering, maintenance, facilities engineering, project engineering, or a related field in a manufacturing environment.
- Experience with industrial utility systems such as steam, condensate, chilled water, cooling water, compressed air, nitrogen, purified water, wastewater, HVAC, and related infrastructure.
- Experience reading and interpreting P&IDs, equipment drawings, specifications, and technical documentation.
- Experience with CMMS systems preferred.
- Experience in pharmaceutical, chemical, or cGMP manufacturing environments preferred.

**OTHER REQUIREMENTS:**

- Strong analytical and problem-solving skills.
- Strong interpersonal, organizational, and planning skills.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Valid New Jersey Stationary Engineer/Boiler Operator license, or ability to obtain license appropriate to site utility systems, required.
- Ability to work cross-functionally and influence without direct authority.
- Ability to manage multiple priorities and work independently.
- Strong understanding of utility systems, maintenance practices, regulatory expectations, and interdepartmental relationships.
- Ability to support troubleshooting and field activities in plant, utility, and mechanical spaces as needed.

**Your Benefits:**

**OTHER REQUIREMENTS:**

- Must have excellent communication skills.

- Must be conscientious and detail oriented.

- Must have excellent computer skills (MS Office 365).

- Must be a team player.

- Must be able to self-manage daily work and set priorities.

- Must be able to manage projects and prioritize appropriately.

- Must be able to adhere to deadlines.
- The salary for this role is anticipated to be between $83,000 - $110,000

Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

Job Description (Your Profile)

ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:

Demonstrates full competency in the operation of all chemical production equipment, such as reactors, kettles, stills, filters, centrifuges, pumps, and demonstrates advanced understanding of chemical processes.

Must be able to obtain and interpret information shown by instruments, such as temperature, pressure, vacuum, or flow indicators, recorders or controllers and make corrective adjustments as required on equipment, based upon information obtained.

Must keep accurate Batch Log Record Sheets showing materials used, produced and pertinent operating information such as pressure, temperature, and vacuum. Accurately labels containers ie. drums, bottles.

Performs simple analytical tests such as pH, foreign matter, Ash test, LOD, and Kf. Also be able to use the mobile EHS monitor (Draeger Tube) and obtains samples from batches or containers and submits these samples to supervisor or laboratory computerized log in system.

Keeps other employees aware of changes in the immediate environment (ie. welding, construction, critical process steps.

Immediately informs the Supervisor of deviations in the process and completes deviation forms as required.

Carries out all work as instructed by the Supervisor, assists when investigations have to be conducted, and takes immediate action in case of emergencies.

Disposes of wastes in a correct manner and is responsible for good housekeeping and cleanliness at workstation.

Performs necessary equipment maintenance as needed to support and continue batch processing.

Safely drives and handles fork and hand trucks in the plant.

Assists with the validation / qualification of processes and equipment and proposes improvements to the processes and equipment.

Aims at the highest possible productivity considering all relevant safety, environmental and quality (cGMP) regulations and guidelines. Knows and follows all relevant Standard Operating Procedures.

Adheres to personal moral, ethical, legal, and behavioral conduct in compliance with the Siegfried Code of Conduct.

All other duties as assigned.

**Your Profile:**

**EDUCATION and EXPERIENCE REQUIREMENTS:**

- HS Diploma or equivalent is required.
- Must be able to read and write legibly in English and perform mathematical calculations such as yield and scale-down batch ratios.
- Prior bulk pharmaceutical experience or batch chemical experience is required.

- Must be able to work accurately and according to written and verbal instructions.
- Must be able to work in a chemical manufacturing plant environment.
- Must be able to obtain respiratory clearance.
- Must also be clean shaven to wear a face respirator when required.
- Must be able to do heavy physical work and climb stairs. The heavy physical work consists of breaking and rolling drums that can weigh up to 400 lbs. Frequency: every shift

**ADDITIONAL SKILLS and QUALIFICATIONS:**

- Must be able to learn and operate computer controlled equipment.
- Having additional computer skills is a plus.
- Must be able to operate in-plant vehicles.
- Must be able to load kettles which requires the operator tips and lifts drums that weight up to 75 lbs. Frequency: every shift.
- Must be able to unloading centrifuges, which requires the operator to scrape cake off the cloth walls and scoop out the material that can weigh up to 5 lbs per scoop. Frequency every shift.
- Ability to stand for long periods of time.
- Able work in extreme temperatures, indoors when required to wear appropriate flame retardant uniform, coveralls or vapor barrier coveralls.
- Must be able to work overtime

Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.

\*\*\*THIS POSITION REQUIRES MEMBERSHIP INTO TEAMSTERS LOCAL 676\*\*\*

**Your Benefits:**

Starting rate $31.08/hr. No-Cost Health Insurance, Competitive Retirement (401k) Plan, Generous Paid Time Off

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Amgen

Clean Utilities Sr 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.

**CLEAN UTILITIES SR. ENGINEER**

**What you will do**

Lets do this. Lets change the world. 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 subject matter expertise to support operations upon start up.

The Utilities System Owner reports to the Director of the Amgen North Carolina Facilities & Engineering group.

- Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
- Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
- Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
- Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
- Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
- Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
- Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
- Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
- Own investigations of abnormal conditions through Deviation and business processes.

**What we expect of you**

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

**Basic Qualifications:**

- High school diploma / GED and 10 years of Engineering/Maintenance experience OR
- Associates degree and 8 years of Engineering/Maintenance experience OR
- Bachelors degree and 4 years of Engineering/Maintenance experience OR
- Masters degree and 2 years of Engineering/Maintenance experience OR
- Doctorate degree

**Preferred Qualifications:**

- Bachelors degree in Chemical, Mechanical, or Electrical Engineering
- 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, and Clean Air generation and distribution; and as well as other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
- Experience with equipment and facility control systems operation, logic, and troubleshooting.
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
- Great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering 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.

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.

North Carolina

Eli Lilly and Company

Project Manager - Equipment Development Group

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

**Job Position Overview:**

The Project Manager is a member of the Equipment Development Group (EDG) within the Engineering Technology Center (ETC). EDG’s mission is to provide innovative engineering and equipment solutions in support of customers across Lilly’s global research, development, and manufacturing communities by integrating new and established technologies, both internally and through external suppliers, to create world-class solutions for a wide variety of technical challenges.

The Project Manager is responsible for all aspects of project delivery including resource allocation, and vendor scheduling, taking the lead position on each dedicated project team and interacting directly with customers to determine requirements, timelines, and budgets. The Project Manager communicates with skill group members and EDG management to ensure appropriate allocation of personnel, participates in project prioritization, coordinates with external EDG/Lilly partners on capacity and staffing in support of project execution.

**Key Responsibilities:**

- Lead project initiation and customer interaction to define user requirements, project scope, timeline, and budget
- Serve as primary customer point of contact throughout the project lifecycle, ensuring requirements are clearly documented and communicated to all stakeholders
- Develop project proposals and maintain project schedules and budgets, track milestones, manage resource allocation, and participate in project prioritization
- Drive design document completion across project phases and lead factory acceptance testing (FAT) and site integration activities for equipment
- Mentor EDG personnel to advance their technical growth and project management capability
- Champion safe, compliant, and effective operations by supporting departmental activities, maintaining HSE compliance, fostering cross-functional collaboration, and promoting continuous improvement across diverse work environments

**Basic Requirements:**

- B.S. in Engineering or related-science field.
- Minimum of 3 years of experience leading cross-functional project teams in an engineering, manufacturing, or equipment development environment.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1*

**Additional Preferences:**

- Experience coordinating multiple concurrent projects and managing competing priorities across a dynamic engineering services organization.
- Proficiency with Microsoft Office Products with focus on MS Project for project scheduling, resource management, and portfolio tracking.
- Familiarity with Autodesk Inventor or AutoCAD 3-D modeling software for mechanical design review and collaboration with design team members.
- Experience with robotic systems integration in manufacturing automation applications, including design, integration, and commissioning of robotic assembly or handling systems.
- Experience in design for ergonomics and safety, including application of human factors principles to equipment design and manufacturing environment layouts.
- Experience with validation and qualification activities for manufacturing equipment in GMP-regulated pharmaceutical or device environments, including IQ/OQ/PQ protocol development and execution.

**Additional Information:**

- Position Location: US: Indianapolis IN Tech Center South
- Travel Percentage (%): 15% required; some international travel may be required.
- Shift Information: Standard 8-hour day, Monday through Friday, with some allowance for flex time; overtime and some weekend or holiday work may be required to support global site engagement across time zones and business needs

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

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

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

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

$67,500 - $173,800

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

\#WeAreLilly

Indiana

Capital Cost Estimator – Industrial Process and Pharmaceutical Equipment

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

**Position Brand Description:**

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

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

**Role Summary:**

The Industrial Process Capital Cost Estimator develops owner-side Class 5 through Class 1 estimates for major pharmaceutical process equipment, packaged systems, process piping, hygienic systems, process utilities, equipment installation, and related construction scopes. The role converts evolving process and engineering scope, equipment data, vendor information, execution strategies, market data, and benchmarks into complete, traceable, and decision-ready estimates. The role will assess equipment freight, rigging, setting, modularization, fabrication, specialty welding, testing, passivation, validation support, spare parts, and vendor field services.

**Key Objectives/Deliverables:**

- Develop capital cost estimates from Class 5 through Class 1 using methods appropriate to the maturity of project definition, including capacity-factored, parametric, assembly-level, unit-rate, and detailed quantity takeoff methods.
- Prepare estimate plans, estimate workbooks, quantity takeoffs, pricing build-ups, bases of estimate, assumptions, exclusions, qualifications, and supporting documentation for assigned scopes.
- Interpret business requirements, basis-of-design information, drawings, specifications, equipment lists, process flow diagrams, P&IDs, layouts, schedules, contracting strategies, and construction execution plans to define estimate scope and cost.
- Build labor, material, equipment, subcontract, construction management, temporary facilities, logistics, indirect cost, escalation, and contingency inputs appropriate to the assigned discipline and estimate class.
- Obtain and normalize vendor budget quotes, contractor pricing, market rates, productivity factors, location factors, escalation inputs, and historical cost data.
- Identify scope gaps, overlaps, ambiguities, estimate risks, cost drivers, and missing inputs; document their treatment in the estimate and Basis of Estimate.
- Perform cost benchmarking using historical project data, comparable facilities, market intelligence, and normalized unit-cost metrics to validate estimate reasonableness, identify cost drivers, and explain variances. Develop and maintain internal benchmarking databases using actual costs from completed and active projects and maintain current insights into relevant external benchmarks. Complete estimate reconciliation, variance analysis, and estimate-to-estimate bridging as scope and design mature.
- Support multidisciplinary estimate reviews and page-turns with project teams, engineering partners, construction partners, procurement, and project controls.
- Prepare estimate summaries and clear cost narratives for project reviews, funding decisions, value engineering, option analysis, bid evaluation, and change assessment.
- Maintain estimates in Oracle Unifier PMIS to provide a complete and auditable estimate trail.

**Minimum Requirements:**

- Bachelor's degree in engineering, construction management, quantity surveying, or a related field, or equivalent relevant experience.
- At least 5 years of direct capital cost estimating experience for industrial, manufacturing, life sciences, or similarly complex capital projects.
- Demonstrated experience personally developing estimates across multiple levels of project definition, including conceptual and detailed estimates.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1*

**Additional Preferences:**

- Experience estimating pharmaceutical, biotechnology, chemical, food, semiconductor, advanced manufacturing, or other process-intensive facilities.
- Experience with both owner and contractor estimating environments.
- Professional certification such as AACE Certified Estimating Professional (CEP), Certified Cost Professional (CCP), or an equivalent credential.
- Experience with benchmarking, estimate reconciliation, value engineering, bid leveling, and change estimate development.
- Familiarity with CSI MasterFormat, Uniformat, equipment-based process estimating, and owner work breakdown structures.
- Ability to work independently, manage multiple estimate assignments, and clearly communicate limitations and uncertainty.

**Additional Information:**

- Must reside in or relocate to Indianapolis, Indiana with onsite presence at Lilly Technology Center-South
- Ability to travel up to 25%, including domestic and international project locations

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

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

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

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

$130,500 - $211,200

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

\#WeAreLilly

Mixed Modality (Peptide Downstream) Scientist - Process Translation and Execution

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

**Overview:**

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

**Organization and Position Overview**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development, Lebanon, Indiana. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates (ADC, ARC, etc.) Through cross-functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies and aligns with corporate and Lilly Research Labs (LRL) goals, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success.

In the Foundry Construction and Project Delivery/Startup Phase (2025 to 2028), roles will be ﬂuid and dynamic as we build a new organization, design and implement the necessary systems and business processes required to enable operational readiness, support the project delivery, and build the site culture. Success will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry transitions from design to startup and ultimately to steady-state operations and continuous improvement. This period presents a unique opportunity for learning, growth, and making a lasting impact.

We are seeking passionate and agile chemists to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life.

**Responsibilities**

In this role, the Mixed Modality (Peptide Downstream) Scientist will be responsible with evaluating and facilitating the transfer of peptide downstream manufacturing processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and isolator production environments). This enables the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.

- Perform peptide purification and isolation and assess purification methods from early phase process research and development labs
- Familiarity with performing peptide downstream procedures, such as reverse-phase chromatography, TFF, lyophilization, and precipitation & drying.
- Evaluate the safety of the incoming procedures in collaboration with the safety group and process engineering.
- Ordering and staging chemicals.
- Obtain reference materials and participate in setting up analytical methods.
- Reprocess and analyze analytical data to make fact-based decisions.
- Efficient with summarizing and presenting chemistry and challenges.
- Perform familiarization executions to ensure plant readiness of process steps including chemical reactions, purification, TFF, lyophilization, and precipitation & drying at the Lilly Medicine Foundry.
- Perform use-tests of key in-process materials and document Definitive Lab Trials of processes to confirm plant readiness.
- Maintain a well-organized and detailed lab notebook with accurate descriptions of the procedures, observations, and organized analytical data to enable the preparation of technical packages/technical transfers and accurate replication in receiving labs.
- [Documentation:](<https://www.google.com/search?sca_esv=07cdbffa48f41bdb&cs=0&sxsrf=AE3TifPMvTaonOh9bWGLSZVCcp5Ku-ESCA%3A1761067824732&q=Documentation&sa=X&ved=2ahUKEwig2-Dw6LWQAxUoE0QIHS7LMXYQxccNegQIPBAD&mstk=AUtExfAvUVYFxKXw3PacmOn7gh4tr0v5R8Ec1sft--3jq1e2vqpabpJQYeAdD7_0LQg4Z_GqkAiJELV3A45HTgw7X82iYYgxSjQ9NTR6GsdZupp9g9dIPjSj0vyIA4lmVyueaOsDGGprrqJLfFE5z_m8WkPP6JVJaOoUjHX8V5MZW-IITWE&csui=3>)Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
- Process improvement: Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.
- Contribute to process troubleshooting and investigations by supporting process deviations, quality events, and non-conformances. Collaborate with teams to perform root cause analysis (RCA) and develop effective corrective and preventive actions (CAPAs)

**Basic Requirements:**

- B.S. or M.S. in chemistry, chemical engineering, or related field.
- 3+ years of experience in synthesis peptide purification and/or manufacturing environments involving synthetic peptide API or drug substance. Reverse-phase chromatograph is preferred.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

**Additional Preferences:**

- Working knowledge of peptide downstream chemistry and purification and application towards improvement and optimization.
- Experience with peptide purification techniques used for developing and scaling-up chemical reactions. Experience using process chemistry concepts is a plus.
- Proficiency with peptide purification via chromatography and TFF and downstream conjugation and cyclization.
- Comfortable working with larger sized preparative columns, TFF, and related-equipment.
- Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
- Has experience creating batch records and conducting scale-up experiments according to those records.
- Ability to prioritize multiple activities and manage ambiguity.
- Experience with a variety of analytical techniques: HPLC/UPLC, LC-MS, GC, NMR, etc.
- Process quantification and acquiring mass balance for products and by-products.
- Demonstrated ability to drive projects and accept change.
- Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams
- Familiarity with peptide upstream synthesis and cleavage and understanding of precipitation and safe handling of solids/dry end processing.
- Problem-solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
- Ability to work cross-functionally across disciplines and levels with engineers, analytical chemists, chemical technicians, safety and quality representatives.

**Other Information:**

- Initial location at Lilly Technology Center, Indianapolis and/or Carmel, IN
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Limited domestic and international travel (\< 5%) may be required for this role
- Role requires ability to work in manufacturing and laboratory environments

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

\#WeAreLilly

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

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

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

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

$66,000 - $171,600

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

\#WeAreLilly

Advisor / Sr. Advisor - Discovery Process Chemistry

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

**Job Description**

**Discovery Process Chemistry**

Lilly Small Molecule Discovery (LSMD) • Louisville, CO

**Company Overview**

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

**Organization Overvi**ew

Lilly Small Molecule Discovery is purpose-built to create molecules that make life better for people, using innovative science to unlock novel approaches for diseases with poor treatment options. Within Advanced Molecule Design, the Discovery Process Chemistry team focuses on route scouting, leveraging advanced synthetic technologies, and enabling rapid scale-up to deliver up to hundred-gram quantities of key intermediates and potential drug candidates.

**Position Summar**y

This is a lab-facing scientific role. The scientist will design and execute multi-step synthetic routes to deliver key drug intermediates and candidates on aggressive discovery timelines, applying process chemistry principles to optimize reactions for yield, purity, safety, and scalability. The role takes advantage of our world-class facilities and scientists in Louisville and throughout the Lilly network, leveraging in-house enabling technologies and, where appropriate, CRO partnerships to accelerate molecule progression toward the clinic, and offers the opportunity to work in a collaborative, growth-oriented team that values individual accountability and collaboration.

Responsibilities

Top candidates for this position will be expected to:

- **Route design:**  Design and execute multi-step synthetic routes to deliver key drug intermediates and candidates on aggressive discovery timelines, applying literature precedent creatively to develop differentiated strategies for assigned targets.

- **Process chemistry:**  Optimize reactions for yield, purity, safety, and scalability, anticipating future scale-up requirements from early-stage work.

- **Enabling technologies:**  Use flow chemistry, photochemistry, electrochemistry, and automated synthesis platforms to accelerate synthesis and improve process robustness and share learnings to help expand these capabilities.

- **Safety:**  Conduct thermal risk assessments (DSC, reaction calorimetry) and hazard evaluations as a standard part of safe scale-up; complete risk assessments before experiments and escalate concerns immediately.

- **Developability:**  Proactively assess synthetic feasibility, route complexity, reagent availability, and estimated cost of goods at the earliest possible stage, and communicate synthetic risk and developability flags to the project team.

- **CRO collaboration:**  Complement hands-on in-house work by providing clear scientific direction to CRO partners, critically reviewing deliverables, giving actionable feedback, and escalating scientific or quality issues to the project lead as appropriate.

- **Tech transfer and documentation:**  Prepare high-quality experimental reports, synthetic procedures, and data packages, and support tech transfer by preparing process documentation and participating in knowledge transfer with CMC colleagues.

- **AI/ML and digital tools:**  Integrate AI/ML tools, predictive modeling, and data-driven approaches into synthetic planning and reaction optimization, and data visualization solutions to extract insights from experimental data.

- **Collaboration:**  Engage openly in cross-functional discussions with tox, ADME, analytical, and CMC colleagues; independently prioritize competing demands; and mentor and develop team members.

- **Scientific communication:**  Identify opportunities for internal or external publications, posters, and presentations.

- **Compliance:**  Follow all site safety, environmental, documentation, and regulatory requirements. Actively reinforce a safety-first team culture.

**Basic Qualification**s

- Ph.D. in Organic Chemistry, Inorganic Chemistry, Medicinal Chemistry or other closely related discipline  **_(All requirements must be met no later than August 2027);_** OR M.S with 8+ years of relevant industry experience; OR B.S with 10+ years of relevant industry experience.

**Strongly preferred**

- **Synthetic and process chemistry:**  strong background in synthetic organic chemistry, including route scouting, reaction optimization, process chemistry, and scale-up, with extensive working knowledge of modern methodologies, isolation and purification techniques, and structural characterization.

- **Enabling technologies:**  experience with flow chemistry, photochemistry, electrochemistry, or automated synthesis platforms.

- **Developability:**  familiarity with early-stage developability concepts, including synthetic feasibility, cost of goods, and regulatory starting material designation.

- **CRO management:**  experience managing or coordinating work with CRO partners in a discovery or process chemistry context.

**Additional skills and preference**s

- Demonstrated ability to independently design and execute multi-step synthetic routes in a drug discovery or process chemistry setting.

- Proven track record of contributing to peer-reviewed scientific publications.

- Effective English-language written and verbal communication skills.
- Active engagement with current synthetic chemistry literature, with discernment regarding the limitations and scalability of new transformations.
- Proficiency with Microsoft Office, ChemDraw, SciFinder, Reaxys, and other scientific data tools.

- Working familiarity with data science tools or AI/ML applications relevant to synthetic chemistry workflows.

- Proven ability to mentor junior scientists and contribute to a collaborative, inclusive team culture.

- Strong organizational skills with a track record of delivering high-quality results under competing timelines.

**Additional Informatio**n

- Work environment is laboratory-based, with hands-on work with chemical reagents, synthetic equipment, and analytical instrumentation; standard personal protective equipment is required. Occasional support of work across multiple lab spaces or collaboration in office and meeting environments is needed.

- Potential exposure to chemicals, allergens, and loud noises.

- Travel: 0 to 10%.

- Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job.

- Lilly is an EEO/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

- Qualified applicants must be authorized to work in the United States. Lilly is able to provide support for work authorization and visa sponsorship for this role for qualified candidates.

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

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

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

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

$141,000 - $231,000

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

\#WeAreLilly

Colorado

ADMA Biologics

Specialist QA II Manufacturing Oversight

Job Description

**ADMA Biologics** is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a **Specialist QA II Manufacturing Oversight in Boca Raton, FL!**

Job Title: Specialist QA II Manufacturing Oversight

Job Description:

**Position Summary**

The **QA Specialist II - Manufacturing Oversight** will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

The QA Specialists team provides 24/7 manufacturing oversight coverage. Specialists are required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM).

**Essential Functions (ES) and Responsibilities**

- Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Deviation Reports.
- Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
- Review and release of Plasma pools to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Review and release of raw materials in LIMS/SAP.
- Perform audits of Nitrogen receipt process.
- Perform notification and disposition of associated Lookback units.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.\\
- Write, review, and revise QA SOPs.
- Review SOPs and documents from other departments and provide feedback as necessary.
- Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
- Assist with training of new employees.
- Coordinate and perform any additional activities or projects assigned by QA Management.
- Experience with LIMS and SAP preferred.

**Job Responsibilities or Job Requirements**

**Competencies**

Exceptional organizational and communication skills required

Must have excellent writing and oral skills

**Experience Requirements**

**EDUCATION REQUIREMENTS:**

- Bachelor's Degree preferred but can be offset by experience.

**EXPERIENCE REQUIREMENTS:**

- 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.

**Preferred Experience**

**Compliance Requirements (ES)**

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensive benefits package including:

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.

Florida

Specialist QA I Manufacturing Oversight

Job Description

**ADMA Biologics** is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an **Specialist QA I Manufacturing Oversight in Boca Raton, FL!**

Job Title: Specialist QA I Manufacturing Oversight

Job Description:

**Position Summary**

The **QA Specialist I - Manufacturing Oversight** performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

**Essential Functions (ES) and Responsibilities**

- Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Event notifications.
- Possess and understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Review and release of Plasma pools to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Perform review and release of raw materials in LIMS/SAP.
- Perform audits of Nitrogen receipt process.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.
- Assist in other oversight activities, as needed.
- Coordinate and perform any additional activities or projects assigned by QA Management.
- Experience with LIMS and SAP is preferred.
- Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers)
- Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift.

**Job Responsibilities or Job Requirements**

**Competencies**

Ability to follow the cGMP’s and procedures with great attention to detail

**Experience Requirements**

**Experience Requirements:**  1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry preferred

**Education Requirements:** Bachelor's Degree preferred but can be offset by experience.

**Preferred Experience**

**Compliance Requirements (ES)**

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

**In addition to competitive compensation, we offer a comprehensive benefits package including:**

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.

Scientist II, Process Development

Job Description

**ADMA Biologics** is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a **Scientist II, Process Development in Boca Raton, Florida!**

Job Title: Scientist II, Process Development

Job Description:

**Position Summary**

The Scientist II, Process Development supports the development of protein purification processes.

**Essential Functions (ES) and Responsibilities**

- The standard schedule for ths position is 8:00 AM to 5:00 PM, but employees may frequently be required to work 12-hour rotating shifts during operational campaigns and manufacturing model runs.
- Responsible for developing new or improved protein purification processes.
- Design, execute, analyze studies, with direction and guidance of management.
- Remain current on developments in the field.
- Make recommendations to management, analyze project goals and criteria to ensure they are scientifically sound.
- Interface with departments such as PD, Manufacturing, RA, Quality, as appropriate.
- Demonstrate strong technical expertise and provide business centered, innovative solutions to process improvement and development initiatives.
- Excellent written and oral communication skills.
- Statistical analysis for analysis and interpretation of data.

**Job Responsibilities or Job Requirements**

**Competencies**

**Experience Requirements**

Education Requirements:

- Master’s degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline.
- Bachelor’s degree and 5 years of process development or protein purification experience.

Experience Requirements:

- 4+ years of experience developing protein purification processes.
- Up to 5 years of experience in a GMP environment.

Other Essential Knowledge:

- Protein biochemistry, especially immunoglobulin chemistry.
- Protein purification.
- Process development scaling of processes from the bench scale to commercial manufacturing.
- Statistical analysis.

**Preferred Experience**

**Compliance Requirements (ES)**

Job Description Footer:

In addition to competitive compensation, we offer a comprehensive benefits package including:

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet InsuranceCompany paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.

US Commercial Operations Finance Business Partner - US Vaccines

**Job title:**  US Commercial Operations Finance Business Partner - US Vaccines

**Location:** Morristown, NJ / Cambridge, MA / Swiftwater, PA

**About the job**

This role supports US Vaccines business decisions and performance analysis by preparing and reporting financial and non-financial information, budgets and forecasts for the country. The position ensures data quality, compliance and internal controls while working with various stakeholders to contribute to strategy implementation.

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

Strategic Partnership & Business Support:

- Work with various stakeholders contributing to strategies implementation
- Monitor financial operational performance and provide accurate data and advice for decision-making
- Actively participate in business planning processes
- Contribute to strategic and business development projects
- Support business decisions through comprehensive performance analysis

Financial Management & Reporting:

- Prepare and report financial and non-financial information for the country/region
- Develop, manage and monitor budgets and forecasts
- Ensure data quality, compliance and internal controls
- Provide financial reporting and analysis to support business operations
- Interpret financial data to drive business insights and resource allocation

Stakeholder Management:

- Collaborate with cross-functional teams and business units
- Provide financial guidance and support to regional/country leadership
- Communicate financial insights effectively to various stakeholder groups

**About You**

Core Technical Skills:

- Financial Reporting and Analysis (Intermediate to Advanced)
- Planning, Budgeting and Forecasting (PBF) (Intermediate to Mastered)
- Interpreting Financial Data (Beginner to Advanced)
- Internal Control Compliance (Beginner to Advanced)
- Cash Management (Beginner to Experienced)
- Accounting (Beginner to Experienced)

Business & Strategic Skills:

- Risk Assessments (Beginner to Advanced)
- Stakeholder Management (Beginner to Advanced)
- Strategy Development (Beginner to Advanced)
- Business Acumen (Beginner to Advanced)
- Digital Literacy (Beginner to Advanced)

Career Progression Levels

- Advanced financial analysis and reporting capabilities
- Mastered planning, budgeting and forecasting skills
- Strong stakeholder management and strategic thinking

Key Performance Areas

- Effectiveness of business partnership and stakeholder relationships
- Quality and timeliness of financial reporting and analysis
- Accuracy of budgets and forecasts
- Contribution to strategic initiatives, dynamic resource allocation and business development projects
- Compliance with internal controls and regulatory requirements

Qualifications & Experience

- Minimum of 7 years experience in Finance/Accouting
- Bachelor's degree in Finance, Accounting, Business Administration or related field
- Professional finance qualifications (CPA, CMA, ACCA) preferred
- Experience in financial planning, analysis, and business partnering
- Strong analytical and problem-solving skills
- Excellent communication and presentation abilities
- Proficiency in financial systems and advanced Excel skills

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or a lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receiveconsideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civilunion status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for militarystatus;domesticviolence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any othercharacteristic protected by law.

\#GD-SA

\#LI-SA

\#LI-Hybrid

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Novo Nordisk

Warehouse Operator I - 1st

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Perform all aspects of warehousing requirements for OFP Site Durham regarding General Warehouse, Hazardous Storage & Cold Storage, functioning as part of a high-performance team. Perform duties in all of the following areas: SAP/ERP Inventory Control, to include material put-away.

**Relationships**

Reports to Supervisor.

**Essential Functions**

- Handling, labelling & storage of all hazardous materials occupying up to 10,000 square feet of warehouse space, inclusive of Class 1 Division 2 items
- Handling, labelling & storage of GMP non-hazardous materials
- Process material handling operations for hazardous materials in drum, pallet & IBC configurations
- Partner with warehouse sampling operations in completion of tasks, as appropriate
- Follow all safety & environmental requirements in the performance of duties
- Daily inspections of forklifts, warehouse, cold rooms & freezer
- Maintain up to date training status
- Inventory Control of all warehouse materials to include stock put-away & retrieval
- Label all inbound material & pull/stage pallets for sampling team, as required
- Store material in proper storage area/type as defined in SAP/ERP
- Ensure compliance with load/unload procedures
- Ensure all material movements are performed timely & accurately in SAP/ERP
- System knowledge in SAP/ERP: Utilization of system transactions to perform transfer of material & inventory adjustments
- Other accountabilities, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May require corrected vision to 20/25 based on role. May require colour vision based on role. Handles transport of hazardous materials. Occasionally performs critical job functions in extremely cold work environments. Ability to work in loud noise environments with hearing protection. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

**Minimum Qualifications**

- High school diploma or equivalent required. (Associate's Degree, or advanced training in Warehousing/Logistics from APICS/equivalent desired.) required
- Minimum of six (6) months of warehousing or manufacturing experience or equivalent, preferably in a regulatory inspected facility, GMP warehouse, or pharmaceutical industry required
- Basic math skills, including knowledge of metric system required
- Ability to read, write legibly & understand all department documentation required
- Ability to drive non-CDL box truck or similar vehicle for movement of materials on site required

**Preferred Qualifications**

- Computer competencies required, including basic Microsoft knowledge: Outlook & Word preferred
- Knowledge of SAP/ERP, to include entry level Warehouse tasks preferred
- Good written & verbal communication skills preferred
- Training or experience demonstrating an understanding of risks inherent to processing, handling & storage of hazardous materials preferred
- Ability to operate stand-up & sit-down forklifts after applicable training & ability to maintain appropriate licensure preferred
- Proficiency in the following areas: Issuance of approved materials (to scheduled production batches & processing of returns/rejects of materials from scheduled production batches); Material Storage, Labeling & Inspection of incoming raw materials; Maintenance of monthly & annual files as needed to support cGMP’s; Removal/Disposal of expired materials; familiarity with all aspects of operation of Offsite Warehouse a plus
- Excellent organizational skills. Ability to execute a work plan & adapt to changes in schedule rapidly. Self-motivated & able to work with little direct supervision preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Process Automation Engineer - Device Assembly

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

Process Automation Engineer is the equipment expert for their process in a cross-functional technical team to establish and maintain the reliable operation and qualified state of manufacturing lines. The individual will be responsible for developing and implementing process and automation improvements to achieve business needs. The Process Automation Engineer will ensure processes are in-control, capable, and compliant.

**Key Objectives / Deliverables:**

**Safety**

- Ensure a safe working environment by enforcing and following HSE policies and ergonomic environment within process team.
- Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvement.
- Wear proper personal protective equipment (gloves, steel toed shoes, safety glasses) as required by local procedures and the activity being performed.
- Understand safe operation of the equipment within the area.

**Functional Responsibilities**

- Serve as the technical expert for assigned equipment, processes, controls, and design requirements.
- Lead equipment troubleshooting and Root Cause Analysis to resolve operational issues and improve reliability.
- Monitor and analyze equipment performance, trends, downtime, and process data to identify improvement opportunities.
- Develop and implement equipment, automation, control system, and process improvements.
- Support deviations, change controls, maintenance activities, commissioning, qualification, and equipment lifecycle changes.
- Maintain equipment in a qualified state through proper documentation, preventive maintenance, spare-parts strategies, and continuous improvement.

**Fundamental Deliverables & Site Expectations**

- Collaborate and communicate effectively across Operations, Maintenance, Engineering, and technical teams.
- Coach and support team members while actively participating in process team activities.
- Manage multiple priorities and improvement initiatives using effective project management practices.
- Escalate technical, safety, and quality concerns appropriately and maintain required training.
- Provide Tier 2 support for unplanned equipment downtime and represent Process Engineering on asset delivery projects.
- Support site safety goals and ensure equipment remains qualified and fit for intended use.

**Minimum Requirements**

- Bachelor’s degree in Engineering
- 2+ years of relevant engineering experience in GMP or highly regulated environment
- Strong commitment to workplace safety
- Excellent communication and interpersonal skills
- Ability to work effectively in a fast-paced, team-based manufacturing environment
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1*

**Additional Preferences**

- Process Automation, Process, or Manufacturing Engineering experience
- Pharmaceutical/packaging experience with cGMP knowledge
- Commissioning & Qualification or Capital Asset Delivery experience
- Automation experience with Rockwell, Siemens, and/or Elau PLCs
- Experience with Cognex/Systech vision systems and/or Fanuc/Kuka robotics
- Strong problem-solving and project management skills
- Power BI experience

**Other Information:**

- 8 hour days, after-hour on-call support.
- Occasional travel may be required for training, conferences, capital projects, etc.

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

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

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

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

$67,500 - $118,800

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

\#WeAreLilly

Associate Director: Clinical Supply Chain- Logistics and Vendor Management

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 - Clinical Supply Chain - Logistics and Vendor Management**

**What you will do**

Let's do this. Let's change the world. In this vital role you will manage the global Logistics and Vendor Management team in Development Supply Chain. You will ensure clinical trial supplies move safely, compliantly, and reliably through a global logistics network, while building strong vendor partnerships and developing your team.

**Responsibilities**:

- Ensure set-up and successful operation of logistics network and logistics toolbox in assigned regions for execution of clinical trials
- Determine distribution strategy and ensure the transportation process and vendor performance comply with Amgen quality requirements and local and regional regulations
- Own relationships with key strategic vendors and develop the relationship in line with business needs. Drive value creation.
- Establish effective working relationships with key partners and represents DSC in Amgen networks and cross-functional projects
- Accountable for significant distribution budget
- Guided by general policies and management guidance, independently determines strategy and day-to-day execution and manages assigned budget
- Accomplishes results through coaching and advising professional team members. Is responsible for staff development and ensures team members receive the appropriate and timely training, allocates resources.
- Owns logistics vendor portfolio and drives continuous value creation.
- Contributes to crafting DSC strategy, long- and mid-term implementation plans and goals. Translates these into actionable departmental and individual goals.
- Applies the MAP philosophy, defines individual goals, tracks progress of team members on projects and goals, provides feedback, prepares and performs individual performance reviews
- Is accountable for monitoring the of the logistics network and vendor performance using appropriate key performance indicators.
- Ensures that all processes are performed in a timely, compliant and efficient manner.
- Ensures that processes are set-up and executed in compliance with existing regulations: GMP. GDP, Annex 13 etc.
- Provides guidance and technical advice and becomes actively involved as required.
- Seeks continuous improvement of processes & procedures, initiates and coordinates improvement initiatives. Works closely with peers, partners and global counterparts to achieve global alignment
- Manages the relevant interfaces between the internal and external functional groups involved in the development supply chain at various management levels
- Support the development and execution of the clinical logistics technology roadmap, partnering with internal Digital, Technology & Innovation (DTI teams), Data Sciences and external service providers to align technology capabilities with business needs.
- Monitors the level of satisfaction from the customers and takes appropriate action when necessary.
- Represents the team/ department in cross-functional/ cross-site networks and projects
- Owns and drives execution of key projects related to process improvement, new capabilities/ process requirements and other projects as assigned
- Represents the DSC team in internal and external audits and inspections
- Effectively manages and reports out on distribution budget and continuously seeks efficiency opportunities.
- Willing to travel (up to 5-10% of time)

**What we expect of you**

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

**Basic Qualifications:**

- Doctorate degree and 3 years of supply chain industry experience OR
- Masters degree and 7 years of supply chain industry experience OR
- Bachelors degree and 9 years of supply chain industry experience OR
- Associates degree and 12 years of supply chain industry experience OR
- High school diploma / GED and 14 years of supply chain industry experience

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 of resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Bachelors or Masters degree or equivalent in logistics/ Supply Chain, business administration or life science.
- At least 6 years relevant working experience, preferably in the biotechnology or pharmaceutical industry, with a strong knowledge of supply chain management, logistics principles, international trade principles and clinical development principles.
- At least 3 years of supervisory experience of Bachelor/Master level staff in a (project) management environment and in an international and regulated environment
- Subject-matter expert knowledge of transportation, vendor management and temperature-controlled logistics
- Working knowledge and understanding of GMP regulations, advanced understanding of GDP (Good Distribution Practices) guidelines and SOX regulations
- Operational Excellence/ continuous improvement expertise.
- General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, ICH guidelines, Clinical Trial Directive)
- Experience in working in an international environment
- Fluency in English, both in oral and written communication
- Advanced experience in MS Office applications
- Experience in using ERP systems, preferably SAP
- Leadership curriculum certification
- Project Management certification (PMP, IPMA)
- APICS certification

**Key Competencies:**

- Strong coaching and management skills
- Strong communication, presentation and facilitation skills
- Effective influencing and leadership skills.
- Sound relationship management and organizational skills
- Skilled negotiator, understanding of resource management
- Results- and process- oriented, strong adherence to timelines
- Ability to handle multiple responsibilities and priorities simultaneously in a fluid environment with time pressures.
- Initiator with analytical, problem solving and decision making skills
- Ability to operate in a team or matrix environment
- Self-leadership & motivation
- Thinks strategically, has a general understanding of company priorities and direction and translates these into actionable plans
- Team player in cross-functional and international setting
- Provides guidance in the design and implementation of organization-wide projects and systems
- Considers financial implications of decisions and sets priorities to meet business needs
- Able to distill complex information into a logical concise manner for senior management
- Experience in dealing in changing and ambiguous environment
- Able to act on operational, tactical and strategic level
- Role model for Amgens values and Leadership Attributes

**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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

California

Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift

**HOW MIGHT** YOU **DEFY IMAGINATION?**

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

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

**Manager Manufacturing(Upstream)- Night Shift**

**What you will do**

Lets do this. Lets change the world. In this dynamic role you will be the on-shift front line manager in manufacturing. The schedule is night shift (2-2-3, 12-hour rotation), 5:45PM to 6:15AM. The successful candidate will be leading a team of experienced manufacturing associates responsible for the manufacture of GMP (Good Manufacturing Practices) drug substance. The manager will champion a safe and compliant production environment through structured on floor presence.The manager will be an active participant and role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.

With minimal direction the manager is responsible for leading on the floor operations and staff in manufacturing. The successful candidate must demonstrate strong leadership skills and technical understanding of biotechnology production operations. This individual will be responsible for supervising, coaching, hiring, and development of floor staff.

The front-line manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering on short- and long-term Amgen Operational goals.

Responsibilities

Compliance:

- Ensure safe working environment for all

- Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas

- Evaluate and implement process improvements and optimizations, partnering with Quality, compliance, and EHSS (Environmental, Health, Safety and Sustainability) on change controls

- Interact with regulatory agencies as needed

- Assure proper gowning and aseptic techniques are followed

Staff Supervision:

- Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement

- Responsible for selection, training, evaluation, staff relations and staff development

- Mentor and coach staff members to live by the Amgen Values

- Develop and implement trainings plans and programs, to ensure staff are prepared and compliant

- Ensure adherence to production schedule and maintenance activities

- Interacts with management in optimizing organizational structure and responsibilities

- Ensure plant safety through auditing, evaluations, and cross functional walks

Process/Equipment/Facilities:

- Demonstrate technical mastery of manufacturing processes

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

- Develop, implement, and assess CAPAs (Corrective Action Preventive Action) and solutions to complex problems

- Responsible for elevating and resolving problems during daily operations

- Oversees set up, execution, and completion of critical manufacturing processes/tasks

Administrative:

- Interacts with management in planning, developing, and maintaining budget

- Assist in developing and maintaining department goals

- Other functional responsibilities may be assigned

**Basic Qualifications**

- Doctorate degree
  OR

- Masters degree and 3 years of Manufacturing and/or operations experience
  OR

- Bachelors degree and 5 years of Manufacturing and/or operations experience
  OR

- Associate degree and 10 years of Manufacturing and/or operations experience
  OR

- High school diploma / GED and 12 years of Manufacturing and/or operations experience
  AND
  Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

**Preferred Qualifications**

- Bachelors degree in Life Sciences or Engineering

- Experience in biotechnology or pharmaceutical plant start up

- Basic understanding of upstream and/or downstream operations

- Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

- Knowledge and experience within a cGMP or other highly regulated environment

- 5 years process experience in a cGMP manufacturing facility

- 3+ years of experience in a production Area Lead, Specialist or Manager role

- Strong leadership and teambuilding skills (coaching, mentoring, counseling)

- Experience with performance management including performance reviews

- Conflict Resolution, analytical problem solving, and project management skills

- Thorough understanding of regulatory requirements

- Excellent verbal and written communication (technical) skills

- Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems

**Thrive**

**Some of the vast rewards of working here**

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

Full support and career-development resources to expand your skills, improve your expertise, and improve your potential along your career journey

A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

**careers.amgen.com**

**Ready to Apply for the Job?**

We highly recommend utilizing Workday's robust Career Profile feature to complete the application process. A link to update your profile is available when you click Apply. You can then complete your Workday profile in minutes with the Upload My Experience functionality to upload an updated copy of your resume or you can simply edit the individual sections of your Career Profile.

Please note that you should be in your current position for at least 18 months before applying for internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a Partially Meets Expectations or higher.

Engineer I - 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.

Engineer I - Process Development

**What you will do**

Lets do this. Lets change the world. In this role the Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP commercial GMP operations at AOH. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, validation, maintenance and alteration of systems, facilities and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.

**Outputs**

**Project Management**

Key responsibilities will include supporting the Technical Transfer of the Amgen product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The Engineer must ensure effective communication throughout the Amgen commercial site network with all partners and deliver on technical improvements.

**Technical Support**

Act as a subject matter expert for FDP GMP operations at AOH, and primarily as technical support for new process equipment and technology. This will include GMP process equipment design, testing, characterization and validation. The Engineer will author such documents as well as be responsible for the execution of said protocols. The Engineer is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.

**Operational Excellence**

Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH manufacturing lines by analyzing, designing, and implementing manufacturing and business process improvements.

**Relationships**

The Engineer is expected to build a network of FDP expertise within AOH and across other Amgen commercial operations for product assembly, label and packaging. The position is expected to bring to bear this network in support of technical expertise for equipment design, testing, characterization and validation at AOH.

**What we expect of you**

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

**Basic Qualifications:**

Masters degree

OR

Bachelors degree and 2 years of working in a GMP regulated environment

Or

Associates degree and 6 years of working in a GMP regulated environment

Or

High school diploma / GED and 8 years of working in a GMP regulated environment experience

**Preferred Qualifications:**

- Track record of contributing to multi-functional projects.
- Strong team work, excellent interpersonal and communication skills.
- Experience with devices/combination products and the associated manufacturing process.
- Experience of working with equipment suppliers.
- Ability to work in a highly regulated and ever changing industry.
- Ability to learn and rapidly adapt to new requirements in a fast moving environment.
- An Operational Excellence approach to work product driving rapid results.
- A passion to deliver an excellent work product and develop others with an infective positive attitude!

**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.

Amgen anticipates accepting applications until 5/21/25; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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 Sr 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 Scientist**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will join Amgens Attribute Sciences (AS) department within the Process Development (PD) organization. AS defines the favorable quality characteristics of the therapies Amgen 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 biologic therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), and antibody-drug conjugates (ADCs). Located at our Thousand Oaks, CA office, the PD Senior Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.

- Supervise and provide technical support for a team that provides analytical support for late stage product development
- Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program
- Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
- Manage activities at 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

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The scientist 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:**

Doctorate degree with 5 years in Analytical Chemistry, Biochemistry or equivalent.

Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.

Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics.

Proficient in mass spectrometry techniques including intact mass and peptide mapping assays for characterizing biologic therapeutics

Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF for biologics

Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.

Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools

Strong problem solving and effective multi-functional interpersonal skills.

Ability to develop, validate, transfer and remediate methods for in-process, release and stability testing

Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (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, managing deliverables against timelines

Strong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. informing and defending the Quality Target Product Profile

Works well in cross-functional teams, and across various geographic locations in different time zones

Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

Experience with protein-based and live modality therapies is beneficial (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)

A self-starter and team player with strong leadership and decision-making skill

**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.

Technician I, Process Development

Job Description

**ADMA Biologics** is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a **Technician I, Process Development in Boca Raton, Florida!**

Job Title: Technician I, Process Development

Job Description:

**Position Summary**

The Technician I, Process Development, conducts laboratory and pilot-scale experiments that support the development of new technologies. Partially responsible for the optimization of manufacturing processes and implementation of regulatory requirements. Assists in process development activities, creates scalable processes with improved product yield and reduced manufacturing systems costs. Researches and assists with the implementation of new methods and technologies to enhance operations. Collects, analyzes, interprets and data to improve processes.

**Essential Functions (ES) and Responsibilities**

- The standard schedule for this position is 8:00 AM to 5:00 PM, but employees may frequently be required to work 12-hour rotating shifts during operational campaigns and manufacturing model runs.
- Conducts lab scale studies that include processing of plasma proteins.
- Conducts laboratory and pilot-scale experiments to evaluate and develop new technologies.
- Operation of centrifuges, filtration apparatus, and chromatography systems
- Routine use of monitoring instruments such as pH/ conductivity meters, spectrophotometer, and scale
- Routinely performs sample and buffer preparation including labeling.
- Equipment and Area cleaning
- Completes documentation and data entry as required for procedures and tests performed.
- Adheres to Safety and cGMP practices in execution of job functions.
- Performs testing as needed to generate data for validation and special projects.
- Fulfills requests from management for assistance in other matters as needed.
- Assists in creating scalable processes.
- Assists the manufacturing operations team in problem solving with regard to equipment and systems.
- Participates in the design and start-up of new manufacturing facilities and equipment.

**Job Responsibilities or Job Requirements**

**Competencies**

Possess time management skills and be able to balance multiple job assignments at once

Possesses strong organizational, critical thinking, reasoning, and problem-solving abilities.

Strong organizational, interpersonal and collaborative skills

**Experience Requirements**

- **Education Requirements:** B.S. in Microbiology, Chemistry, Biochemistry, Biology, or related scientific discipline required.

- **Experience Requirements:** Requires up to two years of experience in a laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc) is preferred. Must have the capacity to work at small scale and to transfer to larger applications. Must be familiar with basic lab equipment (pH meter, spectrophotometer, scale, pipettes, pumps, etc.) Requires computer skills (MS Word, Excel, LIMS, etc). Requires excellent organizational skills, and the ability to interact effectively with internal and external colleagues and managers.

**Preferred Experience**

**Compliance Requirements (ES)**

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensive benefits package including:

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet InsuranceCompany paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.