Manufacturing & Production

Regeneron Pharmaceuticals, Inc.

Executive Director, Global Site Management

**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 **Executive Director** to join our **Global Site Management** team.

The **Executive Director, Global Site Management** provides enterprise-level strategic leadership and organizational accountability for global site-facing capabilities. The role sets the global vision and operating strategy for site management, monitoring execution, resource and budget planning, and CRO/FSP/vendor performance across the clinical development portfolio. They will own the continued evolution of the global site management operating model, ensuring regional capabilities, roles, governance, and deployment strategies deliver consistent quality, speed, scalability, and value. The role serves as the senior functional authority for enterprise initiatives requiring regional or global site-management expertise and partners with Therapeutic Area/Program Clinical Trial Management (CTM), Clinical Science, Quality, and Development Operations leadership to optimize portfolio performance.

This role advises senior and executive management, represents the function in key governance forums, and engages external vendors and collaboration partners at the most senior levels. They are accountable for translating development strategy into a differentiated global site-management capability that advances the Regeneron clinical trial portfolio and delivers industry-leading performance.

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

**When & where:**

- Work Location: Tarrytown, NY, Warren, NJ or Armonk, NY
- 4 days per week on site
- Up to 40% Travel may be required

**Discover your role:**

- Provide enterprise accountability for the strategy, organizational leadership, performance, and continuous evolution of Global Site Management, including the following outcomes:
- Establish and advance the global strategy for country key opinion leader, investigator, and site relationships
- Set direction and governance for global study execution, clinical site monitoring, and issue escalation across the portfolio
- Sponsor risk-based, study-specific monitoring strategies and ensure their consistent implementation and effectiveness
- Define enterprise performance, quality, compliance, and productivity expectations for site management and monitoring activities
- Champion standardization, digital enablement, innovation, and measurable value creation across the global operating model
- Own the global workforce and capability strategy for site management, including multi-year FTE and external-capacity forecasts, headcount planning, allocation, utilization, leadership development, and succession across CTL and CRA organizations
- Hold executive accountability for the global vendor strategy, CRO/FSP contracting worth $10M for CRAs and $10M for CTLs, associated investment, capacity, and performance. Lead senior-level vendor governance, commercial and operational decisions, and corrective interventions when performance or quality is at risk
- Oversee management of data and quality issues at the country/site level, partnering with study management, data management, Quality Management Leads and other stakeholders
- Partners with Global Monitoring Oversight, Central Monitoring, Vendor Relationship Management and counterparts at CROs to ensure alignment on (risk-based) monitoring strategies, standards and training requirements
- Serve as the enterprise thought leader and senior subject matter authority for global site management. Influence internal strategy and external industry practice, sponsor cross-portfolio transformation, and build executive alignment for new capabilities, operating-model changes, and strategic investments
- Establish the global CTL capability model, accountabilities, standards, and measures that support study feasibility, site identification and selection, patient recruitment and retention, and resolution of complex investigator-site issues

**This role requires:**

- Minimum Bachelors Degree (Advanced Degree preferred) with 17+ years of experience including 10+ years of functional leadership and people management
- Expert knowledge of drug development, global clinical operations, clinical monitoring, site management, GCP, and applicable regulations, with demonstrated ability to translate scientific and development strategy into scalable operational capabilities
- Extensive experience leading global clinical trial operations and enterprise transformation across multiple therapeutic areas, regions, and development stages
- Experience working with/establishing global clinical site relationships; Cross cultural awareness and fluent in Business English
- Proven executive leadership in setting vision, leading through ambiguity, building high-performing global organizations, developing senior talent, shaping culture, and delivering sustained change at scale
- Demonstrated success leading leaders and managing performance across global, matrixed, and partner-based organizations
- Executive presence and exceptional communication, influence, negotiation, and decision-making skills; able to translate complex issues into clear enterprise choices and mobilize stakeholders to action
- Excellent interpersonal skills and demonstrated collaborative as well as independent working style
- Proactive and self-motivated, ability to align activities with the clinical development plans (CDPs)Strong organizational skills with effective use of time and prioritization

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)**

$255,000.00 - $424,900.00

New York

Manager, Medical Affairs Operations - Uxbridge, UK

**Manager, Medical Affairs Operations**

**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 **Manager, Medical Affairs Operations, located in UK** to join our Medical Affairs team in charge of our Hub Markets, supporting our country organisation in a hybrid work mode. In this role, you will deliver compliant country Medical Affairs activities while collaborating with local Medical Affairs colleagues and cross-functional stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When** & **where:**

- Uxbridge
- Office-based - Hybrid

**Discover your role:**

- Maintain audit readiness through documentation, tracking, and records management.
- Optimise transparency reporting, Anti-Bribery and Anti-Corruption documentation, and compliance processes.
- Complete assigned medical activities in local systems through regulatory and GxP completion.
- Localize global, regional, and local standard operating procedures and work instructions.
- Handle vendor onboarding, contracts, purchase orders, budgets, and expense reconciliation.
- Coordinate medical meetings, congress logistics, agenda flow, actions, and follow-up.
- You bring structure and service focus to cross-functional Medical Affairs operations.

**This role requires:**

- Bachelors degree in life sciences, business, or a related field, or equivalent experience.
- 7+ years in Medical Affairs operations, coordination, project support, or administration.
- Pharmaceutical or biotech environment experience.
- Experience in a country organization or local operating company.
- Solid understanding of compliance, transparency, and regulated country-level processes.
- Fluency in English
- Microsoft Office and relevant systems experience, including Veeva CRM, Vault Medical, PromoMats, and procurement tools.
- Occasional business travel as required.
- Country Medical Affairs operations experience, including event and congress planning.
- Contract and procurement systems knowledge, such as iCertis or SAP.
- Experience partnering with Finance and Procurement teams.
- Commercial operations experience desirable.
- Strong organization, communication, stakeholder management, and cross-functional collaboration skills.

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.

Other Non-US

Staff External Manufacturing Specialist (Drug Product)

**Build our future together:**

We are currently looking to fill a Staff External Manufacturing Specialist as the technical and operational authority for clinical contract drug product (DP) filling operations at CMO and business partner sites. Owns the tech transfer process end-to-end, drives active batch management from pre-production through lot disposition, and is a key GMP decision-maker. Provides technical mentorship and leadership to mid-level specialists, and collaborates with management on compliance strategy and CMO performance in the clinical operations space.

**When & where:**

- Location: East Greenbush, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
- Travel requirement: 25% international and domestic

**Discover your role:**

- Apply deep technical knowledge of aseptic filling unit operations: sterile filtration (bioburden reduction and sterilizing-grade filters), filling (time-pressure, peristaltic, rotary piston), stoppering, capping, and lyophilization cycle development and scale-up.
- Interpret environmental monitoring (EM) data, airborne particulate results, and media fill (APS) outcomes; assess implications for batch disposition and process adequacy.
- Partner with DP MSAT to evaluate and apply lessons learned across the network as it relates to CCI, APS, filling operations, CMO assessments, etc.
- Assess cleanroom design and equipment suitability (ISO 5/Grade A filling zones, Grade B/C support areas) relative to product contamination control requirements.
- Support extractables and leachables (E&L) risk assessments for product-contact materials and container closure system selection.
- Own and lead end-to-end operations of tech transfer to CMO filling sites, gap assessments, risk evaluations and assessments, facility/equipment readiness, engineering run execution.
- Approve Technical requirements document (TRD), Master Batch Records (MBR), validation reports, summary reports, etc
- Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.
- Serve as the primary technical resource for mid-level EM Specialists; provide hands-on guidance on aseptic filling operations, batch record review, deviation management, and CMO oversight.
- Lead sub-teams on continuous improvement initiatives, filling technology upgrades, and CMO performance management.
- Lead deviation investigations and drive CAPA closure for events occurring during or after filling operations; assess impact on batch and filing.
- Track cycle times, yield trends, and reject rates across batches; analyze data for process drift and drive continuous improvement actions with the CMO.
- Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
- Key GMP decision-maker for external DP filling operations; apply FDA 21 CFR, EU GMP Annex 1, and USP/EP/JP compendia requirements.
- Ensure CMO change controls are appropriately evaluated for regulatory impact; coordinate post-approval change strategies with Regulatory Affairs.
- Review CMC sections of regulatory submissions (IND, BLA/NDA, MAA) related to DP manufacturing and filling as required.
- Support GMP audits of CMO sites; identify compliance gaps, assess risk.

**This role requires:**

- A Bachelors degree or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related discipline and 10+ years in pharmaceutical/biopharmaceutical DP manufacturing, with significant direct experience in sterile filling and CMO oversight. May substitute proven experience for education requirement.
- Hands-on technical experience with sterile drug product filling operations (aseptic filling, lyophilization, CCI, inspection) in a GMP environment.
- Demonstrated experience leading or executing tech transfer of DP filling processes to CMO sites, including MBR/TRD approval, PPQ, and process validation.
- Experience leading deviation investigations and CAPA development for sterile filling operations.
- Demonstrated ability to mentor and develop technical staff; experience providing guidance in a team or lead capacity.
- Strong analytical, communication, and cross-functional collaboration skills; ability to influence and make decisions in ambiguous situations.

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)**

$108,000.00 - $176,000.00

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.

Senior Director, Commercial Business Operations & Systems

**Build our future together:**

We are seeking a strategic and highly experienced leader to serve as Senior Director, Commercial Business Operations and Systems, reporting to the Executive Director, Field Enablement and Engagement Strategy. This individual will lead the Commercial Business Operations and Systems organization including a US-based Director and an International Director and will own the strategy, architecture, and end-to-end lifecycle of the organization's customer facing colleague platforms, systems, and processes.

The Senior Director is the organization's deepest functional expert on the systems, processes, and market-level requirements both US and international that shape how commercial technology and operational infrastructure come together to power field and customer engagement globally. This remit is a critical, direct feed into how strategy and roadmap decisions are made across the enterprise.

The ideal candidate is a systems thinker with deep commercial technology and process expertise across markets and a track record of driving enterprise-wide transformation someone who can shape strategy at the enterprise level while leading a team that translates it into rigorous architecture, governance, and global execution for the business and our customer facing colleagues.

**When & where:**

- Location: In the Sleepy Hollow, NY Office 4 days a week

**Discover your role:**

**Commercial Platform & Systems Strategy**

- Own the global strategy, architecture, and roadmap for the commercial organization's full customer facing colleague platforms ensuring they are designed as an integrated, future-ready whole rather than a collection of point solutions.
- Serve as the organization's deepest functional expert on commercial facing colleague platforms and systems including the distinct requirements of US and international markets and ensure that expertise directly shapes strategy and investment decisions, not just their execution.
- Serve as the accountable leader for the health, evolution, and technical direction of these platforms and systems, making build-vs-buy, sequencing, and investment decisions that align to enterprise priorities.
- Own the long-term, 3-5 year platform and systems roadmap, bringing market-level insight (US and international) on emerging technology, regulatory nuance, and competitive dynamics that informs where the roadmap should go.
- Set standards and governance for platform architecture, data flows, and system interoperability across the commercial technology landscape.
- Manage and optimize the commercial technology investment portfolio, ensuring prioritization is transparent, sequenced, and grounded in market-level cases.

**Process Strategy & Enterprise Design**

- Lead the strategic design and continuous reinvention of the core commercial processes that govern how field and customer-facing teams engage, plan, and implement including planning, engagement, and performance-management workflows bringing deep knowledge of requirements to ensure these processes work in practice, not just on paper.
- Establish global and regional process standards and operating models that balance enterprise consistency with the flexibility Business Units and individual markets need to compete effectively, serving as the primary voice for market-level requirements in how those standards are set.
- Identify structural opportunities to simplify, automate, or reimagine commercial processes, using platforms and AI to remove friction and elevate field and customer experience.
- Own the governance model that ensures platforms, systems, and processes evolve together as a coherent commercial operating model, rather than in silos.

**Strategic Leadership & Stakeholder Partnership**

- Serve as a chief strategic commercial partner and co-owner on the commercial customer facing colleague technology and process agenda across Business Units, IT, Compliance, and Training.
- Represent the platform and process strategy in senior governance forums, business reviews, and enterprise planning cycles, bringing the market and technical expertise needed to build consensus and secure investment.
- Bring an external and forward-looking perspective informed by industry trends, competitor capabilities, and emerging technology across both US and international markets to continually challenge and elevate the organization's commercial platform strategy.
- Build the argument for, and lead the change management around, major shifts in how the organization's commercial platforms and processes operate, partnering closely with training teams and ensuring end user capabilities and confidence in using these systems to meet customer needs and advance business priorities.

**Global Scale & Portfolio Leadership**

- Lead the global portfolio of commercial customer facing colleague platform and process initiatives, ensuring strategic coherence, appropriate sequencing, and disciplined execution across regions and Business Units.
- Partner with Enablement and Business Unit customers to ensure global platform and process strategy reflects real market-level needs and is adopted and adapted appropriately, without compromising enterprise scalability.
- Define the metrics and success framework used to evaluate platform and process performance, and hold the organization accountable to measurable business outcomes.

**Team Leadership**

- Build, lead, and develop the Commercial Business Operations and Systems team including a direct-reporting US Director and International Director fostering a culture of critical thinking, accountability, and high performance.
- Ensure the US and International Director roles are structured so that market-specific requirements (regulatory, cultural, operational) are surfaced early and consistently into the broader strategy and roadmap, rather than treated as after-the-fact localization.
- Serve as a key advisor on organizational design, capability-building, and resourcing needed to deliver the commercial platform and process strategy.

**This role requires:**

- Bachelor's degree required; MBA or advanced degree preferred.
- 15+ years of progressive experience in commercial technology, business operations, or commercial strategy, ideally within pharmaceutical, biotech, or another regulated industry.
- Demonstrated experience owning the strategy and architecture of commercial platforms and systems (CRM, digital engagement platforms) at an enterprise or global scale, including direct experience with both US and international market requirements.
- Strong understanding of the market rules, regulations, and compliance requirements that govern commercial engagement across geographies (e.g., promotional regulations, data privacy standards, and HCP/customer engagement codes), and the ability to design platforms and processes that meet these requirements by design.
- Proven ability to design a global vision and strategy while architecting harmonized, market- and region-specific programs balancing enterprise-wide consistency with the flexibility individual regions or markets need to operate effectively and compliantly.
- Strong track record of leading large-scale process transformation and operating-model design across a matrixed, multi-business-unit organization.
- Systems-level thinking, with the ability to see across platforms, processes, and organizational boundaries to design a coherent commercial operating model.

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)**

$216,100.00 - $360,200.00

Novo Nordisk

Senior Manager, Supplier Management

**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**

Lead, manage, and develop the team. Handle supply and supplier management of raw materials for API production delivered from suppliers to NN sites. Identify and develop solutions to issues arising in crisis situations as well as during qualification and optimization projects. Ensure supply chain solutions that support the overall strategic direction of Sourcing Operations (SoOp), Product Supply (PS), and NN. Represent SoOp in the relevant stakeholders' groups in the sites they serve. Develop strong collaboration across different groups of internal and external stakeholders in a global context. Foster a climate of continuous improvement and innovations within own teams and across related organizational entities. Ensure team is inspection ready and work in compliance with relevant standards.

**Relationships**

Reports to Director Global Supplier Operations API (GSO API)

**Essential Functions**

- Lead team by coaching, mentoring, developing, and overseeing daily activities of direct reports within the team
- Contribute to the successful performance of the team through close collaboration with stakeholders across the relevant NN flows, taking on cross GSO API responsibilities and projects
- Ensure effective supply management handling of API materials managed in Global Direct Procurement, delivered from suppliers to PS sites
- Act as GSO API sourcing representative in relevant groups as well as a GSO API representative in PS Core Groups to develop new processes for delivering the material and optimize supply chains
- Ensure supply chain solutions support overall strategic direction of GDP, PS, API M1-US, and NN while remaining inspection ready and working in compliance with relevant standards
- Drive global sourcing of production materials from worldwide vendors to NN sites within PS and CMC on time, in full, and in QDC balance
- Ensure that each category has an appropriate operational governance model established, securing effective execution of projects & operational tasks, a model is in place to manage supplies, supplier relationships are developed with Strategic Sourcing (SSIMS) and other relevant stakeholders
- Lead cross-organization optimization projects by driving and coaching the project teams and recommending solutions and best practices
- Ensure the team is operating in compliance with ES Quality Management System, relevant core SOPs, internal procedures, regulatory requirements (GxP) as well as compliant and ready for audits and inspections
- Support management with data related to demand, capacities, inventories & supplier management related issues while being responsible for giving input to & updating assigned Balanced Scorecard Metrics & related departmental KPIs within Supply Chain
- Secure continuous improvement in customer satisfaction through feedback, collaboration, and effective communication with all stakeholders within & external to the site
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

**Development of People**

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

**Qualifications**

- Bachelor's Degree in Supply Chain Management, Economics, Engineering, or a relevant field of study from an accredited university required
- Minimum of five (5) years of experience in Supply Chain Management, material or production planning, or manufacturing with a preference towards pharmaceutical or other regulated industries required
- Minimum of three (3) years of leadership, management, &/or supervisory experience in a manufacturing environment with a preference towards pharmaceutical or other regulated industries required
- APICS Training & Certification, CSCP or CPIM a plus
- Experience leading/managing projects of various sizes/complexity preferred
- Excellent verbal & written communication skills; ability to communicate across cultural barriers; ability to communicate with various management levels internally and externally required
- Proven process improvement & problem-solving skills preferred
- Strong knowledge of LEAN concepts & Flow manufacturing skills preferred
- Familiarity with SAP systems (BW, APO, ECC preferred) preferred
- In-depth understanding of Novo Nordisk production processes as well as support processes such as, Quality Control & Quality Assurance preferred
- Proven expertise in mentoring & staff development, change management, planning & organizing, managing execution & revising work plans for complex issues addressed by cross functional teams required

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

Legend Biotech

Operations Support Specialist

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an **Operations Support Specialist** as part of the **Manufacturing & Supply** team based in **Raritan, NJ.**

**Role Overview**

The CAR-T Operations Support Specialist will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule.

**Key Responsibilities**

- Perform process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.  Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.
- Build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule.
- Support the development of manufacturing processes, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals

**Requirements**

- Bachelor’s degree in engineering or related field or equivalent experience required.
- A minimum of 0-1 years of operations experience within a cGMP environment in the biotech/biopharma industry.
- An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
- Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.
- Ability to lift a minimum of 50 lbs and stand for a long period of time.
- Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records.
- Ability to handle human derived materials in BSL-2 cleanroom facility.
- Physical dexterity sufficient to use computers and documentation.
- Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.
- Ability to accommodate unplanned overtime on little to no prior notice.

\#Li-RN1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$47,861 - $62,819 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

New Jersey

QA Warehouse Specialist III

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **QA Warehouse Specialist III** as part of the **Quality** team based in **Raritan, NJ.**

**Role Overview**

The QA Warehouse Specialist is an exempt level position with responsibility of supporting Warehouse activities related to material receipt, handling and release as well as incoming and release of patient material/final product at the Raritan, NJ Legend CAR-T manufacturing site.

**Key Responsibilities**

- Be part of the quality team responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment.
- Reviews, inspects, and disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to complete receipt process.
- Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.
- Conducts routine housekeeping checks of the Warehouse and supporting areas.
- Conducts routine reviews of warehouse documents and logbooks to ensure that GDP are being adhered to.
- Ensures that all materials are in the proper location and under the appropriate storage conditions.
- Make appropriate quality decisions in support of warehouse activities.
- Ensure that cycle counts are accurate and performed in a timely manner in accordance to the procedures.
- Review and inspect documentation in support of Final Product Shipments.
- Generates inspection reports and non-conformances for failures as required.
- Scanning, filing and archival of QA related documents.
- Updates supervisor of work status or problems with recommendations for improvement or correction.
- Good decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
- Other duties will be assigned, as necessary

**Requirements**

- 0-4 years of relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
- Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
- Proficient in the use of quality systems such as SAP.
- Experience working with cell therapy is preferred.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practice is required.
- Excellent written and oral communication skills are required.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

\#Li-BZ1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$96,267 - $126,351 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

GenScript

Intern - Logistics (Shipping)

**About GenScript**

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

**Job Responsibilities:**

- Provide support in processing and confirming shipping documents for logistics operations.
- Assist in preparing and maintaining documents and customs declarations related to shipments.
- Assist in recording and data entry for daily order processing and shipping activities.
- Support the arrangement of picking, packing, and shipping processes.
- Assist in monitoring and updating inbound and outbound shipment data.
- Support in tracking freight costs and assist in uploading and analyzing related data.
- Assist in communication with internal teams to ensure logistics processes align with production and inventory schedules.
- Assist in basic coordination with freight forwarders and brokers.
- Assist in organizing and maintaining compliance documentation for import and export.
- Assist in preparing and organizing routine transaction data for audits.

**Job Requirements:**

- Bachelor's / Diploma, majoring in Logistics, Supply Chain Management or related disciplines
- Have basic understanding of logistics processes and a willingness to learn more.
- Able to communicate and collaborate effectively with team members and other departments.

**Commitment Period: 5 months and above**

**Benefits:**

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

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

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

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

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

Senior/Principal Scientist – Peptide Technical Services & Manufacturing Science (TS/MS), API

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 Overview:**

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Senior or Principal Scientist will join the Technical Services/Manufacturing Sciences (TS/MS) team who work within a dynamic external manufacturing environment to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/Principal Scientist acts as an SME responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners, process team members and site management.

The candidate will be responsible for technical transfer, process stewardship, process monitoring and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

**Key Objectives/Deliverables:**

- Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes.
- Leads resolution of technical issues including those related to control strategy and manufacturing.
- Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs.
- Build and maintain relationships with development partners and central technical organizations.
- Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
- Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
- Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
- Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation.
- Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices.
- Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
- Maintaining peptide/oligonucleotide processes in a state of compliance with US and global regulations
- Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
- Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists.

**Basic Requirements:**

- Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred)
- 3+ years of demonstrated experience with pharmaceutical manufacturing and working knowledge of regulatory expectations.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.*

**Additional Preferences:**

- Knowledge and experience with Regulatory requirements
- Enthusiasm for changes, team spirit and flexibility
- Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
- Proficiency in delivering complex tasks and/or tasks that are cross-functional
- Demonstrated Project Management skills and ability to coordinate complex projects

**Additional Information**

- Some travel (\<25%) is required
- Some off-shift work (night/weekend) may be required to support 24/7 operations
- **This position is located onsite in Indianapolis, IN and is not approved for remote work.**

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

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

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

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

$66,000 - $171,600

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

\#WeAreLilly

Associate Director- RLT Technical Services/Manufacturing Science Lead

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

The Technical Services/Manufacturing Sciences (TS/MS) Lead at Eli Lilly RLT provides technical leadership and scientific support for drug substance/product manufacturing, ensuring robust, compliant operations, continuous process improvement, and successful technology transfer and lifecycle management.

**Job Responsibilities**

- Lead investigations into deviations and non-conformances, determining root causes and implementing CAPAs.
- Provide scientific and technical leadership for drug substance/product manufacturing, including process monitoring, troubleshooting, and optimization.
- Drive continuous improvement initiatives to enhance process performance, yield, cost, and compliance, and define/sustain the control strategy for a robust, reliable process.
- Support technology transfer for new products, processes, or sites, ensuring successful implementation.
- Develop and execute process validation strategies, including continued process verification (CPV).
- Author and review technical reports, protocols, and regulatory submission documents (e.g., CMC sections).
- Collaborate cross-functionally with R&D, Quality, Manufacturing, Engineering, and Regulatory Affairs.
- Lead the sterility assurance team and its responsibilities.
- Mentor junior scientists and engineers within the TS/MS team.
- Lead or support internal/external audits and inspections with technical expertise.
- Stay current on industry trends, technologies, and regulatory requirements in manufacturing science.

**Job Qualifications**

- Bachelor's degree in Chemical Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
- 7+ years of experience in the pharmaceutical or biotechnology industry, with a strong focus on manufacturing science, process development, or technical services.

**Additional Preferences**

- Strong understanding of cGMP regulations, ICH guidelines, and related regulatory requirements.
- Experience with technology transfer and process validation.
- Proven track record leading complex technical projects and solving challenging manufacturing issues.
- Strong problem-solving and critical thinking skills.
- Excellent written and verbal communication, with ability to explain complex technical information to diverse audiences.
- Collaborative, team-oriented approach to cross-functional work.
- Experience in Radioligand Therapies highly preferred.

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

$123,000 - $180,400

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

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>).

Associate Director, Lab Operations

**The Opportunity:**

Reporting to the Director of Laboratory Operations, as the **Associate Director, Laboratory Operations**, you will provide leadership for laboratory operations within the Knoxville Laboratory and is responsible for overall operational performance, quality, compliance, staffing, and resource management across laboratory functions and shifts. You will lead Managers, Senior Managers, and operational support leaders to ensure the laboratory meets safety, quality, service, financial, and operational goals. You will work closely with the Director, Quality, Validation, Human Resources, Facilities, IT, and other business partners to support a safe, compliant, and efficient operation while preparing the laboratory for future growth.

**The Role:**

**_Strategic Execution & Performance Management_**

- Translate lab-wide goals into actionable plans for assigned departments; establish KPIs and lead performance reviews to ensure goal achievement.
- Monitor and manage Laboratory Operations Key Performance Indicators (KPIs).
- Implement course corrections to achieve goals and contribute to monthly operational reports and presentations.

**_Operational Excellence & Process Optimization_**

- Lead initiatives to improve lab efficiency, throughput, and quality, including infrastructure upgrades and system enhancements.
- Analyze operational data to identify trends, diagnose root causes, and implement corrective actions to improve lab performance.
- Manage day-to-day capacity and organizational capability to perform high-volume testing required for the release of plasma per customer specifications.

**_Regulatory Compliance & Quality Oversight_**

- Ensure adherence to FDA, CLIA, cGMP, and internal SOPs; maintain inspection readiness and lead corrective/preventive actions.
- Ensure laboratory operations comply with all relevant regulatory agencies (FDA, CLIA, GHA, etc.). Maintain an "inspection-ready" condition at all times, drive corrective/preventive actions (CAPA), and ensure staff are trained in current SOPs.

**_Leadership & Talent Development_**

- Leads and develops Managers, Senior Managers, and operational leaders.
- Oversees staffing plans, succession planning, leadership development, employee relations, and workforce planning to support current and future operational needs.

**_Financial & Capital Management_**

- Supports development of operating budgets, staffing plans, and resource requirements.
- Monitors financial performance and works with laboratory leadership to ensure resources are aligned with operational demands and business priorities.

**_Cross-Functional Collaboration_**

- Partners with Quality, Validation, Human Resources, Facilities, IT, Engineering, and other business partners to support laboratory operations, implement improvements, and address operational challenges.

**_Stakeholder Engagement & Industry Relations_**

- Serves as a key representative for laboratory operations.
- Builds effective working relationships with internal and external stakeholders and supports business continuity, benchmarking, customer service, and operational planning activities.

**_Safety & Facility Oversight_**

- Promote a culture of safety and compliance; ensure facility maintenance meets operational and regulatory standards.
- Maintain a clean, efficient, and safe work environment.
- Ensure strict adherence to Environmental Health and Safety (EHS), OSHA, and Standard Operating Procedures (SOPs).

**_Change Leadership & Innovation_**

- Leads major operational changes that affect laboratory functions, staffing, workflows, systems, or business processes.
- Supports implementation of new technologies, equipment, and operational improvements while ensuring organizational readiness and adoption.

**Your Skills & Abilities:**

- Bachelor’s degree in chemical, biological, or clinical laboratory science, or medical technology from an accredited institution required.
- Medical Technologist preferred.
- Minimum of 8 years of relevant laboratory experience, including at least 4 years of leadership experience in a laboratory, healthcare, manufacturing, pharmaceutical, biologics, or other regulated environment.
- **Regulatory Knowledge:**  Demonstrated working knowledge of FDA regulations, including GMP, GLP, and CLIA standards.
- **Financial Acumen:**  Experience monitoring departmental budgets and managing resource allocations.
- **Leadership & Communication:**  Proven ability to manage, motivate, and develop supervisory teams. Strong written, verbal, and presentation skills to effectively communicate metrics and drive operational results.
- **Problem Solving:**  Excellent critical reasoning and analytical skills to resolve recurring operational defects and manage shifting priorities under tight deadlines.

**Key Leadership Competencies**

- Strategic thinking
- Operational leadership
- Organizational effectiveness
- Change management
- Cross-functional collaboration
- Continuous improvement mindset
- Quality and Regulatory focus

**Working Conditions:**

- Ability to compute, analyze, and interpret operational data and statistical forecasts.
- Fast-paced environment with frequent interruptions.
- Frequently sitting, with a moderate amount of time walking the laboratory floor and standing.
- Must be able to wear personal protective equipment (PPE) and tolerate occasional exposure to extreme temperatures and bloodborne pathogens. Ability to lift/carry up to 40 lbs.
- Overnight travel required up to 15–20% of the time.
- **Schedule Flexibility:**  Ability to work a flexible schedule, including weekends, evenings, and holidays, to provide operational oversight across all 7 days of operation and multiple shifts.
- **Operational Availability:**  Maintains operational accountability for a 7-day (24/6) high-volume testing environment, requiring occasional visibility and presence on alternate shifts to support leadership teams and manage critical escalations.

*Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.*

**About CSLPlasma**

[CSL Plasma](<https://www.cslplasma.com/>)operates one of the world’s largest and most sophisticated plasma donation networks,with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company,[CSL](<https://www.csl.com/>)(ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people.

Learn more about CSL Plasma here [https://www.cslplasma.com/](<https://www.cslplasma.com/>) and CSL, CSL Behring, CSL Seqirus and CSL Vifor here [https://www.csl.com/](<https://www.csl.com/>).

Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL Plasma benefits visit [https://cslbenefits.com/cslp](<https://cslbenefits.com/cslp>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Tennessee

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.

California

Web Manager, Web Strategy & Operations (Remote)

**Join Amgens Mission of Serving Patients**

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

Since 1980, we have 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, you will 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 lie within them, you will thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Web Strategist, Web Strategy & Operations**

**WHAT YOU WILL DO**

The Amgen Global Content Excellence Team is looking for an experienced Web Strategist to join Global Customer Capabilities & Innovation (GCCI). GCCI delivers efficient and consistent quality global marketing assets that scale across multiple channels & markets. As part of the GCCI, the Web Strategist provides integrated end-to-end program and project management to ensure successful delivery of websites, brings thought leadership and drives delivery.

**Key Responsibilities:**

- **Strategic Web Program Lead:**  Serve as a subject-matter expert on CMS, Design System, back-end system integrations, pharmaceutical web marketing best practices and emerging trends. Advise brand teams on how to apply current web capabilities to business objectives and audience needs, and identify opportunities to strengthen digital experiences. Translate business goals into strategic recommendations and proactively define future-state capability enhancements and roadmaps, partnering with business, technology, content, design, analytics, and agency teams to assess feasibility, value, and dependencies. Promote enterprise standards and consistent, scalable, compliant experiences.

- **Portfolio Prioritization & Planning:**  Lead quarterly intake and prioritization of web initiatives with Technology and business stakeholders, aligning investment to enterprise strategy, business value, and resource capacity. Translate prioritized needs into actionable scope, requirements, sequencing, timelines, and delivery plans. Assess cross-project and platform dependencies, clarify ownership, and apply governance to support informed prioritization and delivery.

- **Web Delivery & Release Management:**  Lead cross-functional web initiatives from approved plans through development, launch, and hypercare. Coordinate creative and content handoffs, development, approvals, QA/UAT, deployment, and production validation. Align timelines, resources, budgets, dependencies, and release requirements; establish launch readiness; facilitate decisions; resolve issues; and communicate status and escalations to support successful, timely delivery.

- **Program Governance, Compliance & Risk Management:**  Monitor program health, governance adherence, documentation, risks, issues, and change impacts across web initiatives. Coordinate business, content, creative, development, technology, analytics, and agency partners to clarify ownership, manage handoffs, and resolve conflicts across concurrent initiatives, platform migrations, technology releases, and regulatory deadlines. Embed legal, regulatory, privacy, accessibility, brand, and operational resilience requirements throughout delivery, escalating material risks as needed.

- **Performance & Continuous Improvement:**  Partner with analytics and SEO teams to interpret web traffic, user behavior, search performance, and other digital insights, and use findings to recommend website optimization. Lead structured retrospectives and apply performance insights, lessons learned, and emerging trends to recommend improvements to web capabilities, standards, tools, templates, and delivery processes. Scale effective practices to improve consistency, efficiency, collaboration, and speed to market.

**WHAT WE EXPECT OF YOU**

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

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 6 years of digital or web project management experience

Or

Bachelors degree and 8 years of digital or web project management experience

Or

Associates degree and 14 years of digital or web project management experience

Or

High school diploma / GED and 16 years of digital or web project management experience

**Preferred Experience:**

- **Digital Program / Project Management Expertise:**
  6+ years of experience managing end-to-end digital and website lifecycle projects in fast-paced, multi-stakeholder environments, including complex, cross-country, and high-impact initiatives.

- **Agile & Program Management:**
  Strong knowledge of Agile methodologies (preferably SAFe) with experience managing website roadmaps and continuous improvement initiatives. Proficient in Program / Project Management tools such as Workfront, JIRA, ServiceNow, Confluence, and Google Analytics.

- **Stakeholder & Vendor Management:**
  Proven ability to negotiate priorities, manage expectations, and build productive relationships across diverse, cross-functional teams and external partners.

- **Regulatory & Technical Acumen:**
  Experience operating in regulated industries (preferably pharma) with understanding of compliance requirements. Familiarity with accessibility standards (WCAG), privacy regulations (GDPR, US consumer laws), web technologies (e.g., HTML/CSS), and industry best practices is a plus.

- **Documentation & Governance:**
  Experience developing detailed project documentation and translating business requirements into technical specifications.

**Preferred Competencies:**

- **Leadership & Collaboration:**
  Effective communication, relationship management, and cross-functional collaboration skills; able to convey complex technical concepts clearly to non-technical stakeholders.

- **Analytical & Digital Expertise:**

- undefined

- **Problem-Solving & Quality Focus:**
  Advanced problem-solving capabilities, attention to detail, and commitment to delivering high-quality outcomes while incorporating feedback.
- **Adaptability & Growth Mindset:**
  Proactive, inclusive, and flexible approach with a willingness to learn, experiment, and continuously

**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's application deadline is 11/15; 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

Environmental Health & Safety Manager

Join Amgens Mission of Serving Patients

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

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

**Environmental Health and Safety Manager**

**What you will do**

Lets do this. Lets change the world. We are looking for a highly experienced Environment Health, Safety and Sustainability (EHSS) Manager to drive world class EHSS performance in a Research and Development laboratory environment. Role is focused on Industrial Safety, Chemical Safety, Risk Assessment and EHS Regulatory Compliance.

In depth understanding of chemistry and biology laboratory operations is required to ensure EHSS requirements are met. The candidate is expected to have strong leadership skills to affect change and influence R&D leadership to achieve and drive significant change and improvement through proactive process improvements by:

- Delivers results through influence and communicating effectively with clients and through practical integration of EHS processes with business practices.
- Independently take action to drive improvement in EHS performance in key program areas.
- Manage complex problems and coordinate the implementation of innovative solutions.
- Change agent who drives improvement in a matrixed environment.

Functions (Duties/Accountabilities):

- Provide Client support (EHSS advance culture change, training, risk reviews, incident investigations, lab specific change controls, etc.) to research and development departments.
- Conduct laboratory-based risk assessment, ensure employees are trained and appropriate engineering controls are in place to minimize employee risk.
- Serves as program owner and subject matter expert for industrial safety compliance (LOTO, Hot Work, Machine Guarding, Dock Safety) and change control programs.
- Conducts analyses of incident causes and associated hazards to be used to target specific prevention strategies in laboratory environments.
- Lead or support Human Performance (HOP), Incident Investigation and/or Root Cause Analysis, for particularly technically complex or high hazard incidents.
- Makes recommendations to management regarding potential environmental, health, and safety business impacts.
- Ensure hazards are identified and risks are proactively assessed.
- Establish safe work procedures for hazardous work being performed in chemical and biological laboratories.
- Analyze metrics and establish action plans to drive continuous improvement.
- Participate on the Emergency Response Teams and address emergency response cases at the site.

Liaisons:

- Reports to Site EHSS Director
- Participate in EHSS Global Network Teams
- Frequently interacts with Engineering, Project Managers, Business Continuity, and Facilities.

**What we expect of you**

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

**Basic Qualifications:**

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

**Preferred Qualifications:**

- Degree in, chemical engineering, engineering, chemistry, biology or other science areas, or environmental, safety, or industrial hygiene.
- Experience in Risk Management, including developing and implementing EHS risk management programs in Chemical and Biological laboratory operations.
- Strong understanding of Chemical and Biological laboratory operations.
- Proven success in managing industrial safety and change control programs.
- Familiarity with risks and controls around high potency compounds and explosive atmospheres.
- Applied knowledge and understanding of EHS principles and practices, regulatory standards, and requirements in context of business activities.
- Well-developed skills in leadership, communication, program development and project management.
- Proficient in Microsoft Office, Smartsheets, Teams, AI, and other computer software systems.

**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 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

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.