Engineering

Regeneron Pharmaceuticals, Inc.

Senior Process Development & Technology Engineer (Device Assembly)

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a hands-on Process Characterization and Technology Engineer to develop, characterize, and scale GMP assembly processes for drugdelivery device combination products, as well as for packaging and labeling operations. This person will provide technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

**When & where:**

- Location: East Greenbush, NY
- Shift Requirements: Monday-Friday- 8-4:30pm
- Travel: 10-20% domestic- sometimes international

**Discover your role:**

- Guide process development and scale-up for GMP assembly of combination products (prefilled syringes, auto injectors, on-body injectors)
- Translate the Quality Target Product Profile (QTPP) into Critical Quality Attributes (CQAs), make risk-based plans for characterization experiments, identify Critical Process Parameters (CPPs), and build a control strategy using ICH Q8Q11 and Q9 principles
- Plan and implement end-to-end process characterization using Design of Experiments (DoE), statistical analysis, and engineering studies to define operating ranges and limits
- Collaborate on development and implementation of in-process controls (IPCs), sampling plans, PPQ approaches, and SPC monitoring with internal and external partner groups
- Contribute to qualification of equipment and tooling, URS/FRS/FAT/SAT and IQ/OQ/PQ
- Support packaging and labeling processes, print/vision inspection, serialization, tamper evidence, and transport and distribution simulation where applicable.
- Author and maintain reports, SOPs, work instructions, and electronic records; ensure compliant change control, deviation investigations, and CAPA effectiveness
- Coordinate with QA, RA, Device Engineering, CMC, Supply Chain, and external CMOs to enable tech transfer and operational readiness; support regulatory filings with clear process narratives and summaries

**This role requires:**

- BA/BS in Engineering related field
- Engineer: BS/BA in Engineering with 2+ years proven experience
- Sr Engineer: BS/BA in Engineering with 5+ years proven experience

**Highly preferred qualifications:**

- A background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation
- Experience with auto-injectors, pen injectors, prefilled syringes
- Practical knowledge of 21 CFR Parts 4, 210/211, 820; ISO 13485; and ISO 14971 risk management
- Knowledge of sterilization modalities and implications for materials and packaging (e.g., EtO, gamma, e-beam)
- Experience working with CMOs/CDMOs and delivering tech transfers across sites
- Knowledge of QbD and ICH Q8Q11, Q9 methodologies to define CQAs, CPPs, CMAs, risk assessments (FMEA), and control strategies
- Knowledge of DoE and statistical analysis using tools such as JMP or Minitab; solid understanding of SPC, capability measures, and sampling plans (e.g., AQL)
- Hands-on experience with equipment URS, FAT/SAT, IQ/OQ/PQ, PPQ, and CPV

Does this sound like you? Apply now to take your first step towards living the Regeneron Way!

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $128,700.00

New York

Senior Project Engineer

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Project Engineer to join our growing Project Engineering team. In this role, you will design, specify, and commission new and renovated process and clean utility equipment. You will lead deviation investigations and provide engineering support across manufacturing processes. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Troy, New York, United States
- Work model: Onsite Monday-Friday 8:00am-4:30pm
- Travel: up to 10%, domestic and international

**Discover your role:**

- Design and specify cGMP process equipment, piping, and controls, including engineering documentation
- Manage mid-to-large projects for process equipment and clean utilities, including start-up, commissioning, and site acceptance
- Lead design review and installation of equipment
- Prepare piping and instrumentation diagrams and develop Process Flow Diagrams
- Support QA/Validation with design documents and protocol execution
- Investigate process equipment, utility, and control system anomalies, implementing corrective and preventive actions
- Supervise mechanical, electrical, and automation contractors

**This role requires:**

- Bachelor's degree in Chemical Engineering, Biochemical Engineering, or another relevant Engineering discipline, and the following amount of project/process engineering experience for each level :
- Senior Project Engineer - 5+ Years
- Principal Project Engineer - 8+ Years
- Level will be determined based on qualifications relevant to the role
- Direct experience with biopharmaceutical process equipment is preferred
- Solid understanding of process control systems and automation.
- Thorough knowledge of engineering documentation for cGMP process equipment and sanitary equipment design requirements
- Experience planning and tracking project activities and schedules
- Strong interpersonal and cross-cultural communication skills, with the ability to lead without direct authority

**Gowning and Physical Requirements:**

- Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$88,300.00 - $168,500.00

Associate Director, Site Automation OT Equipment

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Site Automation to join our Operation Technology Small Equipment, supporting either Red Mill (Bulk Manufacturing) or Temple Lane (Internal Fill Finish) Site. This role is providing technical and automation leadership across manufacturing, testing laboratories, and facilities operations. In this role, you will supervise a team and drive accountability across cGMP automation quality systems, software change control, corrective actions, and equipment procurement and qualification while collaborating with Manufacturing, Quality Control, Engineering, and vendor partners.

**When & where:**

- Location: Menands, New York
- Work model/flexibility: Monday - Friday 8am - 4:30pm, onsite
- Travel percentage: 5-10% to US & International travel

**Discover your role:**

- Lead the automation team by setting clear expectations and modeling compliance; ensure adherence to all departmental policies and procedures
- Oversee the cGMP software administration program and automated system periodic evaluation program; ensure SOPs and Software Lifecycle Documentation remain aligned with current regulatory standards and guidelines
- Oversee investigation support for manufacturing deviations, lab testing anomalies, and issues related to automation, software, and hardware
- Lead projects related to corrective action and equipment performance improvement; ensure timely completion of all departmental projects, work orders, and quality management items
- Maintain budget forecast and compliance for the direct team; provide headcount forecasts for department growth to senior management
- Support vendor relationships and ensure compliance with approved suppliers; oversee equipment procurement, commissioning, and equipment and software qualification activities

**This role requires:**

- BS/BA in Science, Engineering, or Software Programming, or equivalent years of direct experience with automated control systems or equipment in lieu of degree
- MBA, MS or advanced degree preferred
- 10+ years of experience with automated equipment in the pharmaceutical or biopharmaceutical industry or related regulated industry, including at least 5 year of direct experience in the design, installation, maintenance, and/or troubleshooting of automated control systems
- Demonstrated experience leading or managing automation teams in a cGMP regulated environment
- Strong working knowledge of cGMP quality systems, software change control processes, and regulatory standards applicable to automated systems
- Experience with vendor management and approved supplier compliance programs preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$147,800.00 - $241,200.00

Senior Manager Automation

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Sr Manager Automation** to join our **IT PMO and Business Operations team** in Limerick in an onsite position.

In this role, you will oversee the group responsible for the configuration and installation of new biopharmaceutical process and manufacturing laboratory equipment while collaborating with personnel in the Automation Department.

This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide.

**When & where:**

- Location: Raheen, Limerick

**Discover your role:**

- Building and leading a team of OT engineers/specialists; providing mentoring, performance management, and career development
- Responsible for ensuring training, development, and compliance of direct reports and subordinate staff
- Coordinating activities related to configuration and support of laboratory and process equipment
- Acting as a Subject Matter Expert during regulatory inspections and internal investigations
- Managing projects related to process equipment and laboratory software automation
- Leading the workflow within automation Support groups; setting priorities and vetting requests for automation services
- Partnering with the Validation Department by providing technical personnel for configuration and qualification of equipment
- Supporting the regulatory compliance and efforts through audit participation and quality systems development
- Collaborating with Manufacturing, QC and Maintenance as a technical advisor
- Ensuring integrity is maintained for data generated during manufacturing and testing of drug product
- Owning the architecture and lifecycle management of OT equipment
- Leading investigations and CAPAs related to OT system deviations, outages, or data integrity events
- Managing OT-related capital and operational budgets, vendor relationships, and service contracts

**This role requires:**

- Requires BS/BA in Science, Engineering or Software Programming and 8+ years of experience (5+ years of supervisory experience)
- Current knowledge of cGMP biotech/pharma operations, industry trends, regulatory and quality policies, procedures and documentation methods
- Solid understanding of software Design Lifecycle and Quality Risk Management
- Demonstrated project management expertise
- Proven capability in resolving complex inter-departmental and organisational issues
- Strength in influencing leaders in cross-functional roles regarding automation solutions

**#IRELIM #JOBSIEST #LI-Onsite**

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

86,800.00 - 141,200.00

Other Non-US

Senior Automation Engineer

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Automation Engineer to join our Automation Engineering team to keep our groundbreaking process controls and process monitoring systems running at peak efficiency. In this role, you will build, develop, and optimize systems for our sophisticated biopharmaceutical manufacturing processes. You will collaborate closely with multiple teams to include Manufacturing, Quality Control, and Facilities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Rensselaer, New York, United States

- Shift Requirements: Monday - Friday 8:00AM - 4:30PM

**Discover your role:**

- Design, develop, and implement software and hardware improvements to automated and new equipment under change control.

- Provide PLC- and HMI-based technical support to various departments per established SOPs.

- Identify, investigate, and resolve manufacturing deviations tied to automated control systems.

- Develop engineering design documents, technical evaluations, and test plans in line with GAMP 5.

- Support process control and monitoring equipment through software design, commissioning, testing, and corrective action.

- Support small manufacturing, engineering, and validation projects.

- Author and execute Factory Acceptance Test and Site Acceptance Test protocols and system specifications.

- Champion continuous improvement as an everyday outlook, not just a metric.

**This role requires:**

- BS in Engineering or a related field, with 5+ years of relevant experience; equivalent combination of education and experience may be considered.

- Experience in the design and maintenance of process control and/or data acquisition systems is required.

- Experience programming and troubleshooting the DeltaV DCS as well as PLCs. Experience with Allen-Bradley and Siemens control system products and video graphic chart recorders is ideal.

- Experience in a regulated manufacturing environment is ideal

- **Gowning and Physical Requirements:**

- Full cleanroom attire (examples may include including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire is required

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$88,300.00 - $143,900.00

Temp - Associate Process Scientist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Temporary Associate Process Scientist** to join our **Process Sciences Lab** team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Raheen, Limerick.
- This is a 12-month contract position.

**What youll do:**

- Supporting the delivery of process solutions to IOPS and contributing to best-in-class laboratory and process validation report packages.
- Assisting in the root cause analysis of process related deviations using scientific datadriven rationale.
- Participating in cross functional teams to understand process issues in technical and laboratory investigations.
- Contributing to the knowledge-based reports summarising conclusion of studies, investigations and process improvements.
- Presenting findings at group meetings.
- Producing and maintaining accurate records in accordance with site procedures and guidelines.

**The environment and physical rhythms of this role:**

- Ability to work well in a team environment.
- You can demonstrate strong communication and interpersonal skills.
- You possess logical troubleshooting and problem-solving skills.
- You have strong written and report writing skills.

**Lets find out if were a fit:**

- Assoc Process Scientist: BSc/MSc Biotechnology, Biochemistry, or related field will be considered or equivalent combination education and experience.
- Process Scientist: BSc Biotechnology, Biochemistry, or related field with 2 years experience; MSc Biotechnology, Biochemistry, or related field with 1 year experience.

**Thrive today. Grow tomorrow.**

**#IRELIM #JOBSIEST #LI-Onsite #REGNIRLPS**

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Novo Nordisk

Senior Quality Assurance Area Specialist I (QA or IT & Automation)

**About the Department**

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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**

Responsible for the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production. Main duties include review of batch reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

**Relationships**

Reports to Manager, Quality Assurance.

**Essential Functions**

- Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions
- Support validation projects in communicating Novo Nordisk project quality requirements & assessing suppliers’ ability to support test/qualification activities to ensure that Novo Nordisk requirements & expectations are clear
- Support projects in solving quality related issues, act quickly in order to come to a decision, & communicate quickly & clearly regarding such decisions
- Support evaluation of the quality level during the project by performing spot checks of validation documentation
- Perform activities related to Batch review & release
- Review & approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
- Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
- Review & approve change control requests
- Review & approve deviations
- guidance to departments regarding quality & related activities
- Participate & provide input to root-cause analysis
- Participate in process confirmations & quality oversight
- Authorized person according to Novo Nordisk Quality Manual
- Other accountabilities, as assigned.

**Physical Requirements**

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. May require the ability to work in loud noise environments with hearing protections.

**Qualifications**

- Bachelor's Degree in Life Sciences, Engineering, or related field required
- Minimum of five (5) years of experience within the pharmaceutical industry required
- Good Knowledge of cGMP manufacturing & production processes & how to apply required
- Good Knowledge of the Batch review Processes required
- Good Knowledge of quality management systems required
- Good Knowledge of quality oversight & on floor production support required
- Strong knowledge level in cGMP’s & validation required
- Strong knowledge in Quality Management Systems required
- Must be ability to perform tasks independently, accurately & within defined time frames required
- Ability to willingly work with customers/stakeholders in a cooperative manner required
- Strong written & verbal communication skills required
- Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
- Proven expertise in planning & organizing tasks preferred
- Willingness to assist others in developing plans in a cross-functional environment preferred
- Innovative approach to establishing priorities 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.

North Carolina

Jazz Pharmaceuticals, Inc.

Automation Engineer

**If you are a current Jazz employee please apply via the Internal Career site.**

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit [www.jazzpharmaceuticals.com](<https://www.jazzpharmaceuticals.com>) for more information.

The Automation Engineer is part of the global automation engineering Function. He/She is responsible for carry out improvement activities, provide maintenance support for existing Manufacturing Process Control Systems and to develop ,sup port new Process Control , Safety Systems deployments across Jazz internal Manufacturing sites. This role ensures the activities carried is aligned with global automation and site specific standards in the design, delivery and deployment. He/she will also be responsible as part of the global automation team to support project and maintenance support of other internal manufacturing sites.

**Essential Functions/Responsibilities**

- Ensure that deployed systems are available for Manufacturing, maintained, and their qualified status is not compromised.
- Assist in Design and implementation of Hardware and Software solutions in accordance with Standard Operating Procedures and the Automation standards.
- Cooperate with the Site Engineering, QA and IS Compliance departments to ensure production continuity and fast problem resolutions. Tasks such as audits, CAPAs and validation testing are completed on time successfully and as priority, in particular:
  - Cooperate with the Manufacturing team, ensuring all system changes are communicated ahead of time and that production schedule is accounted for.
  - React quickly to reports of Manufacturing system faults, troubleshoot in collaboration with Manufacturing and the other Engineering disciplines.
  - Assist in the development software and hardware configuration to remediate system faults or errors, improve efficiency and safety, as requested and in response to CAPA or Error report actions.
  - Carry out preventative and planned maintenance activities on time and suggests/identifies maintenance requirements where needed.
  - Carry out system modifications in accordance with the appropriate Change Control procedure.
- Actively identify & pursue process quality, efficiency, and safety improvements.
- Seeking out opportunity to improve understanding and to raise the profile of the Automation team.
- Ensure all Quality & Compliance tasks are completed on time and as priority.
- Carryout all responsibilities as detailed within applicable Global/Site SOPS available on Jazz EQMS relevant to the task.
- The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
- Manage third party vendors to the interest of Jazz Pharmaceuticals
- For his/her Area of competence, he/she carries out the operating procedures for the management of his/her activity in compliance with the Principles of the Environmental Policy and the Quality System, applies the relevant guidelines and indications contained in the procedures of the Environmental Management System of his/her competence.
- Participates in the training and education courses in the field of the Automation, Environmental, Safety and Quality Management System and in the training courses on Procedures, Instructions, Manuals and Operating Protocols.
- He/She is responsible for carrying out his/her activities so that the management of environmental and safety aspects is conducted correctly. Carries out the work activities, in compliance with the directives received, Guarantees compliance with all applicable Laws, Codes, company standards and Procedures relating to his/her area of competence, particularly the requirements of the Jazz Pharmaceuticals Code of Conduct.

**Required Knowledge, Skills, and Abilities**

- Good knowledge of Distributed Control and Safety Systems and/or PLC applications.
- Awareness of integrated process control using Batch (batch processing).
- Good demonstrable knowledge of Batch process.
- Working knowledge of GAMP and GEP.
- Database experience (SQL).
- Followed system maintenance programmes.
- Capability to install, configure and update Process Control System software ( Rockwell, Siemens)
- Experience in maintaining and upgrading PLC or DCS control systems.
- Soft skills:
  - Able to form long term relationships with key support groups, QA, engineering, CSV group and senior managers across the site.
  - Shares ideas and information and acts in a transparent manner
  - Demonstrates a ‘can do’ approach.
  - Willing to learn new technologies and their application relevant to the job
  - Fluent English
  - Good oral, written and presentation skills essential

- Following capabilities will be considered a valuable plus:
  - The followingExperience in the Pharmaceutical Industry
  - Experience of Safety Instrumented Systems
  - Experience of commissioning activities

**Required/Preferred Education and Licenses**

- University Degree or HND with relevant professional experience
- Good demonstrable knowledge of Distributed Control and Safety Systems and/or PLC applications.
- Experience of PLC based unit operation including graphical interface and data collection. Awareness of integrated process control (batch processing / continuous production).
- Experience of Rockwell (Win CC, Studio 5000, FT View SE etc.) , Siemens (TIA portal, PCS7)

\#LI-MC1

\#LI-Onsite

*Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.*

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: [https://careers.jazzpharma.com/benefits.html](<https://careers.jazzpharma.com/benefits.html>).

Frederick National Laboratory for Cancer Research

Mechanical Maintenance Millwright

**Mechanical Maintenance Millwright**

Job ID: req4724

Employee Type: nonexempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Facilities Maintenance and Engineering (FME) mission is to support the NCI at Frederick in their mission to cure cancer and AIDS. FME is responsible for the physical campus - its research laboratory space, administrative space, the infrastructure that supports the buildings, and the landscape that surrounds them. In addition, we are responsible for managing, planning, designing, and construction management of renovations at the FNLCR.

**KEY ROLES/RESPONSIBILITIES**

- Assembling and installing machines then testing them to make sure they are working correctly
- Examines equipment in operation to determine if adjustments are adequate or if repair is necessary
- Installs a variety of laboratory machinery and equipment as required
- Must work in full compliance with the approved safety regulations
- Performs preventive maintenance to identify and correct potential issues, removing worn out pieces and lubricating mechanical parts
- Basic mechanical principles used in maintaining vacuum pumps, air compressors, air handlers and a variety of industrial equipment
- Performs other related duties as assigned by a responsible authority. Disassemble and repair a variety of industrial equipment; read blueprints and work orders; follow standard practices and craft techniques in installing, maintaining, and repairing industrial equipment
- Works independently using standard trade techniques
- Subject to 24-hour call-in for emergency repairs

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirement, a minimum of five (5) years of mechanical-related experience is required
- Working knowledge of mechanical technical skills to allow them to effectively read documents such as specifications, machine manuals, and blueprints
- Proficient in troubleshooting techniques to solve machine issues
- Mathematical skills and strong attention to detail
- Ability to be a team player due to constant interactions with similar employees and stakeholders such as Engineers, Managers, and Part Vendors, amongst others
- Must have the ability to routinely lift and carry up to 50 lbs.; climb stairs and ladders; work involves bending, stooping, and working in confined areas; potential exposure to particulates, vapors, or noisy environment
- Must have and maintain a valid State Driver's License issued by the state in which the candidate resides. Must have no more than 3 demerit points in the previous twelve (12) months or five (5) demerit points in the preceding thirty-six (36) months as determined by the Leidos Biomed Use of Government Owned or Leased Vehicles Policy
- Experience with construction safety practices
- Must be available to respond to occasional after-hours emergency repair needs, including participation in an infrequent 24-hour on-call rotation
- This position is considered safety-sensitive and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program
- Ability to obtain and maintain a security clearance

**JOB HAZARDS**

- This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance
- This position is subject to working with or has the potential for exposure to animals(s) and/or animal material(s)
- This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

55,400.00 - 81,600.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Maryland

Eli Lilly and Company

Director- Purification- 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.

**Organization and Function Overview**

Lilly is investing $4.5 billion in the Lilly Medicine Foundry, a state-of-the-art facility for advanced manufacturing with drug development. The Foundry’s mission is to accelerate innovation, expand clinical trial capacity, expedite the delivery of new medicines, and reduce costs and environmental impact.

The Process Translation and Execution (PTE) team drives scientific excellence and innovation to accelerate manufacturing advancements. The team translates 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. Through cross-functional collaboration, PTE influences process decisions, revolutionizes clinical manufacturing, building capabilities in emerging technologies and aligning with corporate and LRL goals, and propels the site toward long-term business success.

In the Foundry Construction and Project Delivery/Startup Phase (2026 To 2028), roles will be dynamic as we build a new organization, design lab, develop 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. This period presents a unique opportunity for learning, growth, and making a lasting impact.

**Position Summary**

We’re seeking an experienced and passionate technical leader to join the PTE team as a group leader, and help build a culture rooted in collaboration, innovation, and purpose. This role will be instrumental in shaping a high-performing PTE team, driving impactful contributions to pipeline delivery across modalities, and fostering professional growth and development.

**Key Responsibilities**

**Team Leadership and Development**

- Lead, mentor, and develop a team of PTE scientists with deep technical expertise in downstream bioprocessing (chromatography, TFF/UFDF, viral inactivation, and viral filtration) across traditional biologics and mixed modalities (monoclonal antibodies (mAb), antibody-drug conjugates (ADC), antibody-RNA conjugates (ARC), peptides, oligonucleotides).
- Foster a high-performance environment through regular coaching, one-on-ones, and performance feedback. Promote psychological safety and professional growth.

**Technology Transfer and GMP Production Support**

- Provide technical oversight for clinical DS purification and conjugation process technology transfers from Process Development to Foundry cGMP operations. Lead/support facility fit assessments, risk analyses, and scale-up strategy to ensure right-first-time execution.
- Serve as the primary SME on the manufacturing floor, supporting front-line process teams, leading complex deviation investigations and root cause analysis, and driving CAPAs to closure.
- Collaborate cross-functionally to streamline tech transfer processes, accelerate timelines, and advance digitization of technical documentation and workflows.
- Ensure Foundry processes remain compliant, capable, and in a qualified state throughout their lifecycle. Support tech transfer for product commercialization.

**Site Technology Strategy and Innovation**

- Define and lead the Foundry's purification and conjugation technology strategy, assessing, and industrializing next-generation capabilities in partnership with Process Development, Process Engineering, and Global TSMS.
- Guide/support CAPEX initiatives to keep PTE and Foundry capabilities aligned with evolving portfolio demands.

**Cross-Functional Collaboration and Influence**

- Act as a key technical liaison across Process Development, Process Engineering, Analytical, Quality, Supply Chain, HSE and Operations.
- Represent PTE during regulatory inspections and audits as a credible technical SME.
- Build and maintain external partnerships to advance the site's technology and innovation agenda.

**Basic Qualifications**

- PhD in Biology, Biochemistry, Biological Engineering, Chemical/Biochemical Engineering, or related disciplines.
- 12+ years of industry experience in biologics DS development or manufacturing, with 8+ years of direct experience in purification processes.
- Deep expertise in downstream unit operations including chromatography (affinity, ion exchange, mixed-mode), tangential flow filtration (TFF/UFDF), viral inactivation (low pH, detergent), and viral filtration.
- Experience with column packing, resin lifetime management, and scaling strategies from bench to clinical manufacturing scale.
- Extensive experience in leading, coaching, and developing direct reports, fostering a culture of growth and accountability.

**Additional Skills and Preferences**

- Hands-on experience with bioconjugation processes such as antibody-drug conjugates (ADC), antibody-RNA conjugates (ARC), or related conjugation processes. Familiarity with conjugation reaction optimization, DAR control, and post-conjugation purification including organic solvent handling at moderate scale.
- Experience with single-use downstream processing systems (e.g., single-use chromatography skids, SUMs, single-use TFF) and familiarity with platforms such as PCC/continuous chromatography.
- Working knowledge of process analytical technology (PAT) for downstream operations, including inline UV, conductivity, and pressure monitoring for real-time process decisions.
- Leadership in process innovation and continuous improvement, including complex deviation investigations, root cause analysis, and CAPA implementation.
- Familiarity with emerging purification modalities relevant to next-generation biologics (e.g., mRNA purification, LNP downstream processing, or novel affinity ligands).
- Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements related to pharmaceutical API/DS manufacturing and tech transfer.
- Effective interpersonal and communication skills; strong conflict-resolution skills and experience in building cohesive teams.

**Additional Information**

- Initial location: Indianapolis, IN
- Permanent location: Lilly Medicines Foundry, Lebanon, Indiana.
- Limited domestic and international travel (5–10%) required.
- Ability to work in manufacturing and laboratory environments.

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

$151,500 - $264,000

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

Indiana

Software Engineer- Full Stack

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.

**Full Stack Software Engineer – Software Product Engineering**

**Come develop great software solutions to solve exciting problems that help patients!**

The Software Product Engineering team is looking for a full stack engineer. Are you determined to own and complete complicated and technically ambitious work? Are you passionate about technology, with extensive full stack development experience across both front-end and back-end systems? Our team is actively adopting AI across the development lifecycle to help us build better software, faster, and we're looking for engineers who are excited to be part of that evolution while bringing strong engineering fundamentals. If so, please apply.

**What You'll Be Doing**

As part of a collaborative team of versatile engineers, you will build reusable, composable software components, taking them from design and requirement specifications through implementation, testing, and integration into Software Product Engineering's next-generation platform ecosystem. By continuously improving the design, building for maintainability, and ensuring the product meets both business and patient needs, your work will transform patient experiences and improve treatment outcomes.

**How You'll Succeed**

· Develop, test, and deploy components into provisioned cloud platform environments through automated Continuous Integration and Deployment (CI/CD) processes.

· Review and implement technical designs, translating them into APIs, user interfaces, libraries, and services across a range of programming languages while adhering to Lilly's architecture, design, implementation, and security standards.

· Use AI coding tools to accelerate design exploration, implementation, testing, and debugging, while owning the correctness, security, and maintainability of everything you ship.

· Build and integrate AI capabilities into products, such as LLM-powered features and agent tools, where they improve patient and user outcomes.

· Build working knowledge of medical device delivery models and quality systems, including GxP expectations, to ensure solutions align with regulatory requirements and timelines.

· Integrate open source and licensed components into larger solutions, making practical reuse decisions and ensuring dependencies are sourced through approved enterprise channels (e.g., Artifactory) and meet security and licensing requirements.

· Investigate and propose solutions to development and design problems through open collaboration and healthy debate, including scope estimation and forecasting.

· Collaborate effectively with product managers, designers, engineers, stakeholders, and vendors within the team and across Lilly.

· Establish strong relationships with technical leaders and architects to influence technology direction for Software Product Engineering platforms and products.

· Practice effective source control, code review, and collaborative programming to drive high-quality outcomes.

· Partner with data professionals to implement database and data warehousing solutions.

· Complete projects with minimal supervision and direction.

**What You Should Bring :**

· Experience designing and building cloud-native applications using containerized services and microservices architectures on AWS or Azure.

· Exposure to large-scale architectural patterns, ideally with hands-on experience implementing event-driven systems using Apache Kafka (or similar) for scalable, resilient processing.

· Strong object-oriented programming skills, excellent debugging skills, and expertise with data serialization, REST APIs, and version control.

· Experience with TypeScript, Node.js, or a JVM language (e.g., Kotlin) for building front-end and back-end services, along with HTML, CSS, and SASS; Python experience is a plus.

· Experience building applications with modern JavaScript frameworks (e.g., React, Angular, Vue, Next.js, or Nuxt) and modern build tooling (e.g., Vite, Webpack).

· Familiarity with build automation and containerization technologies such as GitHub Actions, Jenkins, Docker, and Kubernetes.

· Experience using AI coding tools (e.g., Claude Code, GitHub Copilot, Cursor) in your development workflow; familiarity with LLM application patterns such as RAG, tool use, or MCP is a plus.

· A proven track record of Agile software development, demonstrated through a portfolio of software development projects.

**Your Basic Qualifications :**

· Bachelor's degree in Computer Science, Information Technology, or a related technical engineering discipline, including Software Engineering, Computer Engineering, Information Systems, Cybersecurity, Information Science, Network Engineering, Systems Engineering, Computer Information Systems (CIS), Management Information Systems (MIS), Cloud Computing, Data Science

· 2+ years of experience in Software Engineering, including full stack development across front-end and back-end systems

· Experience with multiple languages (polyglot programming), including JavaScript/TypeScript or a JVM language (e.g., Kotlin)

· Professional experience delivering software solutions across the full development life cycle, including project initiation, design, development, testing, deployment, maintenance, support, and retirement

· 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 Information**

Position based in San Francisco, California with a hybrid work model.

**About the organization**

Tech @ Lilly builds and maintains capabilities using groundbreaking technologies like most prominent tech companies. What differentiates Tech @ Lilly is that we create new possibilities through tech to advance our purpose – creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business.

Lilly's Software Product Engineering (SPE) organization is focused on building core foundational software platforms to accelerate our ability to reach and support patients, digitally. This organization is powered by software engineering experts that solve challenging problems around patient engagement and drug discovery with code.

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

$71,250 - $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

California

Lundbeck

Development Associate I - Downstream Process Development

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

**SUMMARY:**

The Development Associate I Downstream Process Development works with a team of scientists and engineers developing production processes for therapeutic biologic candidates in preclinical, clinical, and late-stage development. The primary responsibility will be to purify proteins to support the development of downstream processes. This individual plays a collaborative role within downstream team and with members of upstream, bioanalytical, analytical and formulation development groups.

**ESSENTIAL FUNCTIONS:**

- Performs small-scale downstream process development experiments supporting monoclonal antibody purification, including liquid chromatography and tangential flow filtration.
- Prepares process intermediates and experimental samples for analytical testing.
- Prepares purified protein materials to support process development studies and cross-functional activities.
- Performs analytical methods, such as UV-visible spectrophotometry, turbidimetry, density, pH, and conductivity measurements.
- Collaborates closely with scientists, engineers, and other Process Development team members.
- Manages multiple laboratory activities and priorities while maintaining strong attention to detail and follow-through.
- Proactively communicates experimental progress, unexpected observations, scheduling needs, and potential challenges to teammates.
- Prepares clear, concise summaries, presentations, and reports to communicate experimental results.
- Helps maintain an organized, efficient, and safe laboratory environment.

**REQUIRED EDUCATION, EXPERIENCE and SKILLS:**

- Accredited bachelor’s degree in a scientific or engineering discipline such as Biochemical Engineering, Chemical Engineering, Bioengineering, Biotechnology, Biochemistry, Biology, or a related field.
- Foundational knowledge of one or more of the following areas: liquid chromatography, membrane filtration, protein chemistry, biochemical engineering, or related scientific principles.
- Familiarity with common laboratory equipment such as pH, conductivity, and temperature meters; pumps; pressure gauges; balances; pipettes; and benchtop centrifuges.
- Strong verbal and written communication skills.
- Comfortable asking questions, sharing observations, and keeping teammates informed.
- Strong organizational skills, attention to detail, and the ability to plan and manage multiple priorities.
- A proactive approach to work and a willingness to take ownership of assigned responsibilities.
- Curiosity, enthusiasm for learning, and openness to feedback and coaching.
- Ability to follow standard operating procedures and established laboratory and industry safety practices.
- Proficiency with Microsoft Office applications.
- Ability to occasionally lift up to 30 pounds.

**PREFERRED EDUCATION, EXPERIENCE AND SKILLS:**

- Academic, internship, research, or industry experience with protein purification or downstream processing.
- Experience with ÄKTA chromatography systems and UNICORN software.
- Exposure to pilot-scale or manufacturing-scale biotechnology operations.
- Experience presenting scientific results through laboratory meetings, research projects, internships, poster presentations, or similar settings.

**TRAVEL:**

- Some domestic travel may be required

The range displayed is specifically for those potential hires who will work or reside in the state of Washington, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $32/hour - $39/hour and eligibility for an 8% bonus target based on company and individual performance. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k. Additional benefits information can be found on our [site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>). Applications accepted on an ongoing basis. #LI-LM1

**Why Lundbeck**

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the [U.S. career site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>).

*Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the* [*U.S. career site*](<https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy>).

*Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in* [*E-Verify*](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf>).

Washington

Scientist I - Downstream Process Development

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to advance brain health and transform lives.

**Position Summary:**

The Scientist I is a part of the Downstream Process Development team. This collaborative team develops processes for therapeutic biologic candidates in preclinical, clinical, and late-stage development. The primary responsibility will be to develop scalable and robust purification processes that produce protein within targeted product quality profile for clinical and commercial scales. This individual plays a synergistic role within downstream group and will collaborate extensively with members of upstream, analytical and formulation development groups.

**Essential Functions:**

- Designs, executes, and interprets complex downstream process development studies supporting clinical and commercial biologics programs.
- Serves as a subject matter expert in downstream processing, with particular emphasis on Chromatography, Ultrafiltration/diafiltration (UF/DF), Depth filtration, Viral inactivation and Viral filtration.
- Apply strong experimental design principles to develop efficient, scientifically rigorous studies that address process performance, robustness, and scalability.
- Independently analyses complex experimental datasets, identify trends and risks, and translate results into clear technical conclusions and recommendations.
- Authors and reviews technical reports, development documents, presentations, protocols, and other documentation supporting process development activities.
- Presents scientific strategy, experimental results, recommendations, and technical risks to project teams and senior stakeholders.
- Serves as the Downstream Process Development functional-area lead on cross-functional development programs.
- Partners with Manufacturing and other technical functions to support process scale-up and technology transfer to internal or external manufacturing facilities.
- Provides technical support during manufacturing implementation, including troubleshooting and resolution of process-related issues.
- Collaborates effectively across organizational and geographic boundaries while maintaining clear communication and strong follow-through.

**Required Education, Experience, and Skills**

- Bachelor’s degree and 8+ years’ experience in biopharmaceutical industry or Masters and 6 years’ experience, or PhD and 0-2 years’ experience or relevant combination of education and experience.
- Extensive knowledge of the scientific principles and practical execution of protein purification using column chromatography and filtration techniques including UF/DF, depth filtration, viral inactivation, and viral filtration.
- Demonstrated ability to independently design scientifically rigorous experiments and interpret complex datasets.
- Skilled in Unicorn-based AKTA programming and result evaluation.

**Preferred Education, Experience, and Skills**:

- BS or advanced degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline.
- Experience supporting late-stage process development, process characterization, validation readiness, or commercial process development.
- Familiarity with viral clearance for early and late-stage programs.
- Experience supporting technology transfer activities, including preparation of process descriptions, transfer documentation, risk assessments, and manufacturing support.
- Hands-on experience with pilot-scale downstream processing equipment and operations.
- Familiarity with process characterization, scale-down model qualification, and establishment of proven acceptable ranges or process operating ranges.
- Experience supporting regulatory filings or responding to technical questions related to downstream process development.
- Demonstrated experience leading a functional area on a cross-functional development program and/or leading complex technical project teams.
- Ability to effectively coordinate activities across multiple functions, communicate priorities, identify risks, and drive decisions.
- Excellent verbal and written communication skills, including the ability to communicate complex technical concepts to both technical and non-technical audiences.
- Strong organizational and project-management skills, with demonstrated ability to manage multiple priorities and deliverables.

**Travel Requirements:**

- Domestic and international travel up to 20% may be required.

The range displayed is specifically for those potential hires who will work or reside in the state of Washington, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $135,000 - $155,000 and eligibility for a 10% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k. Additional benefits information can be found on our [site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>). Applications accepted on an ongoing basis. #LI-LM1

**Why Lundbeck**

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the [U.S. career site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>).

*Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the* [*U.S. career site*](<https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy>).

*Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in* [*E-Verify*](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf>).

Amgen

Process Development Senior Scientist

**Join Amgens Mission of Serving Patients**

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

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. 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.

**Process Development Senior Scientist**

**What you will do**

Lets do this. Lets change the world. In this vital role you will join Amgens Pivotal Drug Product Technologies group in Thousand Oaks, CA. The group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgens Late-Stage biologics portfolio.

The ideal candidate will bring hands-on experience in biologics drug product formulation and co-formulation, with experience across multiple modalities, including enzymes, monoclonal antibodies (mAbs), and peptides. The candidate will have a strong understanding of protein attributes,stability and process-related degradation pathways, and analytical strategies for characterizing critical quality attributes (CQAs). This role will integrate formulation, analytical, and process data to guide product design and development. The successful candidate willapplyinnovativetechnologies, including AI and machine learning where appropriate, and collaborate across functions to deliver high-quality, stable, and manufacturable drug products in a fast-paced environment.

- Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
- Design, plan, complete, and document formulation and process development studies
- Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
- Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
- Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co-formulations
- Build process understanding across unit operations to support scalable drug productdevelopment
- Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
- Author/review guideline documents, technical protocols and reports, risk assessments, and regulatory sections in support of IND and marketing application submissions
- Provide support to clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
- Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
- Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs
- Lead cross functional initiatives enhancing drug product platforms and contribute to process design improvement projects

**What we expect of you**

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

**Basic Qualifications:**

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

OR

Masters degree and 3 years of Scientific experience

OR

Bachelors degree and 5 years of Scientific experience

**Preferred Qualifications:**

- PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or related field with 24 years of postdoc or industry experience
- Experience integrating formulation, stability, and analytical data to advance biologics including enzyme, mAb and peptide candidates is highly desirable
- Demonstrated understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparability
- Experience developing or characterizing enzymes, including assessment of activity, stability, and performance under relevant formulation or process conditions
- Experience in formulation and co-formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Strong foundationin analytical and biophysical techniques relevant to biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.)
- Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire)
- Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs)
- Strong project management skills, including the ability to manage ones project resources (material, workforce, time, etc.)
- Critical thinking, problem solving and independent research skills
- Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally

**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.

Engineer - Process Development (Commissioning, Qualification, and Validation)

**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 - Process Development (Commissioning, Qualification, and Validation)**

**What you will do**

Lets do this. Lets change the world. In this role, you will support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at the Amgen Ohio (AOH) site. You will apply strong engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle.

As a key contributor to AOHs growth, you will play an essential role in technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. Your work will help ensure reliable, compliant, and efficient production systems that support Amgens mission of serving patients.

**Key responsibilities of this role include:**

**Commissioning, Qualification & Validation (CQV)**

- Complete commissioning activities and author/implement IQ/OQ/PQ protocols, validation plans, and lifecycle documentation.
- Maintain validated state of equipment and processes through periodic review and documentation updates.
- Participate in equipment and system design review, supporting requirements definition and CQV strategy alignment.
- Support and participate in FAT/SAT, equipment installation, and startup readiness.
- Collect and analyze process and equipment data to support validation, characterization, and sustained performance.

**Technical Transfer & Process Support**

- Support technical transfer of FDP and combination product processes into AOH, ensuring CQV deliverables are met.
- Perform data collection and process characterization to support new equipment and process introductions.
- Trouble shoot device assembly and packaging equipment through engineering fundamentals and multi-functional support.
- Provide technical feedback into change control, deviations, CAPA, and risk assessments (as applicable to validation activities).

**Project Management & Multi-Functional Collaboration**

- Support CQV project planning, schedule alignment, and execution for new or modified equipment and systems.
- Partner with Manufacturing, Process Development, Engineering, and Quality to ensure project deliverables are met on time.
- Maintain effective communication with AOH site teams and the broader Amgen network to ensure alignment on technical deliverables.
- Support documentation reviews, supplier interactions, and internal readiness for inspections or audits.

**Technical Expertise & Equipment Support**

- Serve as a technical resource for automated and semi-automated device assembly and packaging equipment.
- Support trouble shooting and lead investigations for technical issues impacting equipment performance or reliability.
- Review vendor documentation, test protocols, and engineering drawings to ensure compliance with CQV requirements.
- Evaluate equipment and process performance trends to identify improvement opportunities.

**Operational Excellence & Continuous Improvement**

- Identify and support improvements in throughput, reliability, and process capability across packaging and assembly operations.
- Participate in Lean, Six Sigma, and Operational Excellence initiatives to strengthen equipment performance and CQV processes.
- Support data-driven decision-making through process monitoring, trend analysis, and equipment performance assessments.
- Recommend enhancements to CQV procedures, templates, and standard methodologies to increase efficiency and compliance.

**Partner Relationships & Collaboration Network**

- Build collaborative relationships with key site and network groups, including:
- Site Process Development
- Manufacturing & Quality Assurance
- Engineering & Maintenance
- Global Technical & Validation Networks
- External Equipment Suppliers
- Leverage this network to support equipment qualification, technical trouble shooting, validation standardization, and performance trending.

Travel: Approximately 20%

**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 is a leader with these qualifications.

**Basic Qualifications:**

Masters degree

**Or**

Bachelors degree and 2 years in a GMP-regulated environment

**Or**

Associates degree and 6 years in a GMP-regulated environment

Or

High school diploma / GED and 8 years in a GMP-regulated environment

**Preferred Qualifications:**

- Understanding of combination product assembly technologies, automated and semi-automated equipment, and packaging operations.
- Experience supporting CQV activities, including protocol writing, execution, and data analysis.
- Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
- Demonstrated ability to contribute to cross-functional technical projects.
- Experience working with manufacturing equipment suppliers
- Ability to learn rapidly in a complex, fast-moving GMP environment.
- Operational Excellence mindsetLean/Six Sigma exposure preferred.
- 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

**careers.amgen.com**

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

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

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

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

Ohio

Senior Machine Learning 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.

**Senior Machine Learning Engineer**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will contribute to the development of scalable machine learning platforms and workflows that enable scientists and researchers across Amgen to build, deploy, and manage AI/ML models. You will work closely with experienced engineers, data scientists, and domain experts to productionize machine learning solutions primarily in support of drug discovery and development.

This is an ideal role for engineers early in their ML or software engineering careers who want to grow their expertise in MLOps, cloud platforms, and applied AI in life sciences. The ideal candidate has background in software engineering or computer science, has experience with commercial-grade, high reliability software and ML systems, and is passionate about the scientific and engineering aspects of designing new drugs.

This role is eligible for remote work within the US. While the role is remote, the interview process will include at least one in-person interview.

**Roles & Responsibilities:**

- Deliver AI and ML-enabled applications and platforms, with deployed models ranging from classical ML models to natural language processing, protein language models, and large language models.
- Contribute to the development and maintenance of ML platform capabilities, including:
  - Data pipelines and feature engineering workflows
  - Model training, evaluation, and deployment pipelines
  - Experiment tracking and model registry systems
  - Model performance evaluations and monitoring
- Partner in implementation of AI and ML Ops best practices, including CI/CD, cloud infra as code, monitoring, traceability and reproducibility.
- Collaborate with cross-functional teams to transition standards and outcomes from experimentation to production-grade enterprise solutions.
- Build and maintain scalable and efficient, productionized MLOps solutions on cloud platforms.
- Develop and deliver training content and knowledge articles to educate resident scientists on model lifecycle management best practices.

**What we expect of you**

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

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of relevant experience in Computer Science, IT, or related field

OR

Bachelors degree and 4 years of relevant experience in Computer Science, IT, or related field

OR

Associates degree and 8 years of relevant experience in Computer Science, IT, or related field

OR

High school diploma / GED and 10 years of relevant experience in Computer Science, IT, or related field

**Required Skills:**

- Software programming (Python, version control, test driven development).
- Experience with cloud technologies (AWS preferred, Databricks).
- Hands-on experience with AI/ML model training and serving.

**Preferred Qualifications:**

- Experience with deployment and maintenance of AI/ML models in production.
- Substantial experience with cloud technologies and platforms, such as Databricks, AWS (preferred), or Azure.
- Experience with AI and MLOps frameworks and tools (MLflow, Kubeflow, Weights & Biases, Terraform, etc.).
- Experience with containerization (Docker, Kubernetes).
- Familiarity with distributed data processing (e.g., Spark).
- Familiarity with data science libraries (scikit-learn, TensorFlow, PyTorch, LangChain).
- Experience with graph databases.

**Soft Skills:**

- Excellent critical-thinking and problem-solving skills.
- Strong communication and collaboration skills.
- Demonstrated presentation skills.
- Self-motivated, independent ownership and leadership skills.

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

District of Columbia

Manufacturing Specialist-Process Engineer

Job Description

**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.

**Specialist, Manufacturing**

**What you will do**

Lets do this. Lets change the world. This role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer / new product introductions, process validation, manufacturing process/procedures, risk assessments, training, and non-conformance. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on process systems.

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

**Applied Process Expertise**

As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations. Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support. Evaluate, plan, and implement solutions for process improvement opportunities. Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process. Complete risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations.

**Projects and Initiatives**

Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives.

**Process Monitoring**

Support process monitoring parameters and control limits based off critical metrics and recommend improvements. Collect process-monitoring data and support the assessment of deviations. Provide support of timely process monitoring quarterly reports.

**Technology Transfer / New Product Introductions & Process or Equipment Modifications**

Participate in technology transfer / NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

**Non-Conformance and CAPA**

Ensure that all Non-conformance are triage within the established goal. Assist with investigations, corrective actions and NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

**Process Validation**

Assist with the process validation and generation of process validation protocols and reports. Support collection and analysis of process validation data.

**Regulatory**

May participate in regulatory inspections.

**Change Control**

As manufacturing change owner, provide assessments on CCRB records impacting the process.

**What we expect of you**

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

**Basic Qualifications:**

Doctorate degree

**Or**

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

**Or**

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

**Or**

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

**Or**

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

**Preferred Qualifications:**

- Detailed technical understanding of bio-processing and manufacturing operations
- Develop, manage, and implement process improvements
- Experience with Lean principals (Kaizen, Six Sigma, Operational Excellence) and knowledge of problem-solving techniques
- Experience in participating and helping lead cross-functional teams
- Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality
- Experience with change control process and change management
- Skilled in performance of GMP production operations
- Regulatory knowledge and interactions
- Project management skills
- Excellent organizational, technical writing, presentation, and verbal skills
- Knowledge of data analysis and control charting

**What you can expect of us**

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

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

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

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

**careers.amgen.com**

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

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

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

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

AbbVie

LBA Automation Scientist II

Company Description

**About AbbVie**

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

Job Description

The LBA Operations lab within Quantitative Translational & ADME Sciences (QTAS) in Worcester, MA, is seeking a motivated, independent, and experienced automation Scientist to support pre-clinical bioanalytical programs in a non-regulated and fast-paced environment. This role focuses on 1) the bioanalysis of animal samples dosed with large molecule therapeutics, including pharmacokinetic (PK), toxicokinetic (TK) pharmacodynamic (PD), and anti-drug-antibody (ADA) studies using manual and automated Meso Scale Discovery (MSD) assay protocols; and 2) designing and optimizing new automation protocols for the LBA workflow on Tecan and Hamilton liquid handlers.

The primary responsibilities of the Scientist I/II role include developing and executing bioanalytical strategies to support PK, PD, TK, and ADA studies via LBA using automated liquid handling systems. This lab-based role focuses on bioanalytical assay design, planning, data interpretation, and application of automation knowledge to increase analytical capabilities in support of oncology, immunology, and neuroscience portfolios.

The ideal candidate will have a strong background in bioanalysis, biochemistry, chemistry, or related fields along with bioanalytical assay automation. The candidate is expected to execute bioanalytical assay design and data interpretation, while driving automation strategies for pre-clinical sample analysis.

Duties & Responsibilities:

- Design and execute pre-clinical (rodent, NHP) bioanalytical studies using newly developed or existing bioanalytical protocols using manual and automated LBA protocols (Hamilton and Tecan instruments).
- Serve as an automation SME for the lab and set up automated assay strategies for large molecule bioanalysis.
- Effectively and clearly communicate assay plans, timelines, results, and data interpretations with study teams and QTAS stakeholders.
- Train and mentor junior scientists on LBA protocols using automation.
- Archive data in ELN and LIMS systems.
- Write and update experimental protocols and procedures.
- Initiate, design, interpret, and troubleshoot operational assays independently and efficiently.

Qualifications

- Bachelor’s degree in biochemistry, chemistry, or pharmacology with 7+ years industry experience or MS or equivalent with 5+ years of experience.
- Previous experience conducting PK/PD/TK bioanalysis on antibodies, bi/multi-specifics and/or ADCs, including data interpretation is required.
- Highly motivated, reliable, and independent contributor with attention to detail and problem-solving skills.
- Experience with assay development and troubleshooting using ligand binding workflows (ELISA, MSD) is a must. Automation experience is required.
- Team player. Excellent written and verbal communication skills.
- Proficiency with computers and data analysis software, including LIMS systems.
- Ability to design, summarize, communicate, and interpret bioanalytical results.
- Creative leader and problem solver who collaborates effectively in a highly matrixed environment.
  - This position is onsite and located at the AbbVie Bioresearch Center in Worcester, MA.

Additional Information

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

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

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

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

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

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

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

Massachusetts

Scientist II / Senior Scientist I, tLNP Process Development

Company Description

**About AbbVie**

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

Job Description

Targeted lipid nanoparticles (tLNPs) represent a key new modality to enable effective delivery of mRNA. The tLNP chemistry, manufacturing, and control (CMC) team (TCT) is a newly formed group under Biologics CMC, Development Sciences, R&D. TCT focuses on process development for tLNPs, including mRNA process development, tLNP process development, and formulation development.

The tLNP Process Development team is seeking a highly motivated, talented, and innovative scientist with expertise in mRNA-LNP process development and an interest in laboratory automation. This team is responsible for the end-to-end manufacturing process from purified mRNA to purified tLNP bulk drug product, including encapsulating mRNA with lipid components to form LNPs, conjugating LNPs with a targeting moiety, and purifying the final tLNPs via tangential flow filtration (TFF).

The successful candidate will help advance fundamental understanding of tLNP unit operations, such as mRNA encapsulation, bioconjugation, and TFF, as well as scaling up lab processes into pre-clinical, clinical, and commercial scale manufacturing processes. The candidate will also apply automation expertise to integrate off-the-shelf and custom-built hardware, software, and data workflows into flexible experimental platforms that increase throughput, reproducibility, and process understanding.

The end goal for tLNP Process Development team is to deliver a robust manufacturing process at commercial scale. This includes science-based, hands-on approaches in the lab to optimize process parameters and understand the impact of process parameters on critical quality attributes. First-principle-based and statistical modeling will be applied where appropriate. Along the pharmaceutical development life cycle, the team will be responsible for successful production of non-GMP pre-clinical safety study supplies and GMP clinical study supplies from a manufacturing plant on site or at third party manufacturers. The team will also lead the tech transfer of commercial processes into a commercial facility. Additionally, the team reviews appropriate sections of Common Technical Document (CTD) for regulatory submissions.

Success in this role depends on close collaboration with the mRNA process development, drug product development, and analytical development, digital and automation partners, as well as cross-functional partners across Biologics CMC and Synthetic Molecule CMC. The work directly advances cutting-edge mRNA-based therapeutics.

**Responsibilities**

- Independently design, execute and interpret critical experiments to understand unit operations such as mRNA encapsulation, bioconjugation, and tangential flow filtration, and scale up these unit operations to commercial manufacturing batch size.
- Highly autonomous and productive in performing laboratory research or method development, requiring minimal direction from supervisor.
- May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
- Demonstrates high proficiency across a wide range of technologies relevant to tLNP process development.
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- Primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
- Proactively develop and implement innovative automation solutions (custom and off-the-shelf equipment).
- Apply AI tools for structured data capture, analysis, and predictive modeling.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GMP compliance.
- Direct mentorship of others.

Qualifications

- BS, MS, or PhD degree in Chemistry, Material Science, Pharmaceutical Sciences, Bioengineering, Biomedical Engineering, Chemical Engineering, or equivalent.
- **Senior Scientist I**: BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience.
- **Scientist II**: BS with 7+ years', MS with 5+ years' industry experience.
- Experience with LNP mixing technology in an academic lab, or industry experience with LNP drug product process development. For mRNA encapsulation, experience with systems such as impinging jet, coaxial jet, or multi-inlet vortex mixer is required.
- Possess thorough theoretical and practical understanding of mRNA encapsulation.
- Experience with bioconjugation is required.
- Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions.
- Demonstrated ability to learn, understand, and master new experimental techniques.
- Ability to multitask and work within timelines.
- Demonstrated scientific writing skills and strong verbal communication skills.

**Preferred Experience**

- Experience scaling up LNP processes to gram-scale mRNA or above.
- Prior experience with automating existing experimental setups as well as new automation equipment and ecosystems, such as Ignition.

Additional Information

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

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

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

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

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

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

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

Illinois

Codexis, Inc

Sr/Principal Process Engineer

**Key Responsibilities**

- Providing technical leadership in hands‑on process development, applying advanced engineering principles to drive the design, build‑out, and maturation of the ECO Synthesis® platform in close partnership with cross‑functional development teams
- Leading the scale‑up strategy for the ECO Synthesis® platform, ensuring process is robust, well‑characterized, and ready for transition into a cGMP manufacturing environment.
- Championing laboratory safety, maintaining a clean and compliant workspace, conducting process hazard analyses and risk assessments, and ensuring safe working environment for all team members.
- Overseeing documentation quality, ensuring batch records, SOPs, and development reports meet GDP standards; providing mentorship and guidance to early‑career engineers and scientists on documentation and experimental/statistical rigor.
- Leading the development and delivery of key technical work, including internal and external presentations, detailed technical reports, and comprehensive technology transfer packages for siRNA manufacturing processes.
- Owning the creation of engineering design tools, including mass and energy balances, process flow diagrams (PFDs), equipment specifications, and cost models to support scale‑up, facility integration, and long‑term platform deployment.
- Serving as primary technical liaison with external vendors, driving equipment selection, qualification, and support activities essential for effective process development and scale‑up.

**Skills, Knowledge & Expertise**

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field with 10+ years of relevant industrial experience, or M.S. with 8+ years.  
• Expertise in flow chemistry, biocatalysis, or oligonucleotide synthesis technologies (e.g., SPOS, enzymatic platforms).  
• Demonstrated leadership in scale‑up activities, including tech transfer of biocatalytic or nucleic acid–based processes from laboratory to pilot or commercial manufacturing environments.  
• Proficiency in process modeling and simulation tools such as Aspen Plus, SuperPro Designer, COMSOL, or DynoChem; and proficient with data analytics or scripting tools (e.g., R, JMP, Python).  
• Strong leadership, communication skills, with the ability to collaborate effectively across cross-functional teams including R&D, Operations, Quality, and Engineering.  
**Additional experience that would be valuable for this role includes:**

• Prior experience managing early career engineers, scientist, or research associates.

• Expertise in purification technologies, such as chromatography, filtration, or enzyme/oligonucleotide purification workflows.

• Experience with facility design or equipment specification, for nucleic acid manufacturing.

• Deep understanding of quality systems and regulatory expectations, including ISO-based quality frameworks and GMP principles.

**Job Benefits**

- Medical, Dental and Vision Insurance
- Basic Life, AD&D, Short- and Long-Term Disability Insurance
- 401k with Company Match up to 4%
- Company Equity
- Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time
- Annual Lifestyle Account for reimbursement of fitness programs, equipment and more
- Employee Stock Purchase Program (ESPP)
- Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)
- Student Debt Program (Company Contribution to Loans)
- Mental Health Wellness Program
- Subsidized onsite lunch program
- Onsite Gym Facilities
- Paid Parental Leave

And More!