Process Development Engineer II, Advanced Therapy Project Management (ATPM)

Dormont Manufacturing Co; Village of Tarrytown (NY); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron seeks a Process Development Associate to join the Advanced Therapy Project Management group within PAPD Ops on-site in Tarrytown, NY. You will support project management, tech transfer, and business operations for advanced therapy programs, collaborating with CDMOs to enable clear cross-functional ways of working.

This role focuses on driving readiness for manufacturing start-ups, maintaining integrated plans, and delivering risk-mitigated execution across development and transfer

Qualifications

• B.Sc. in Biochemistry, Chemical/Biochemical Engineering, or a related field, with 6-8+ years of experience or a MS w/3-6+, including demonstrated ownership of cross-functional deliverables
• A strong customer-service mindset
• Ability to independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes

Responsibilities

• Lead cross-functional tech transfer teams and independently own workstreams to establish production processes at CDMOs
• Drive readiness for manufacturing start-up by clarifying scope, securing inputs and approvals, tracking deliverables, and escalating risks with proposed mitigations
• Own communication strategy and operating cadence for assigned programs, providing concise, decision-ready status reporting to audiences ranging from core teams to senior stakeholders
• Build, maintain, and continuously improve integrated plans across development and transfer activities, facilitating scenario planning to protect key milestones
• Anticipate and address risks to manufacturing readiness, defining mitigation plans to support rigorous CDMO campaign execution
• Lead recurring and ad-hoc technical forums to drive timely decisions, resolve issues, and capture lessons learned
• Lead continuous improvement initiatives to mature AT-PM ways of working
• Partner with procurement, finance, legal, and internal stakeholders to support CDMO engagement, including RFPs, scope alignment, and contracting coordination

Skills

Cross-functional leadership

Project coordination

Communication

Education

B.Sc. in Biochemistry, Chemical/Biochemical Engineering or related field

MS in related field

Job description

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 Process Development Associate to join our Advanced Therapy Project Management (AT-PM) group within Product, Analytical, and Process Development Operations (PAPD Ops) in an on-site capacity. In this role, you will support project management, technology transfer, and business operations for Regeneron's Advanced Therapy Programs, helping drive successful development and tech transfer of advanced therapies (e.g., AAV, bioconjugates, and synthetic chemistry programs), while collaborating with internal partners and Contract Development & Manufacturing Organizations (CDMOs) to enable clear cross-functional ways of working and operational excellence.

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

When & where:

• Location: On-site in Tarrytown, NY
• Work model/flexibility: Onsite, full-time

What you’ll do:

• Lead cross-functional tech transfer teams and independently own workstreams to establish production processes at CDMOs
• Drive readiness for manufacturing start-up by clarifying scope, securing inputs and approvals, tracking deliverables, and escalating risks with proposed mitigations
• Own communication strategy and operating cadence for assigned programs, providing concise, decision-ready status reporting to audiences ranging from core teams to senior stakeholders
• Build, maintain, and continuously improve integrated plans across development and transfer activities, facilitating scenario planning to protect key milestones
• Anticipate and address risks to manufacturing readiness, defining mitigation plans to support rigorous CDMO campaign execution
• Lead recurring and ad-hoc technical forums to drive timely decisions, resolve issues, and capture lessons learned
• Lead continuous improvement initiatives to mature AT-PM ways of working
• Partner with procurement, finance, legal, and internal stakeholders to support CDMO engagement, including RFPs, scope alignment, and contracting coordination

This role might be for you if:

• You take initiative, reliably follow through, and thrive in non-structured environments, navigating ambiguity and changing priorities with a strategic, action-oriented mindset
• You enjoy and excel at problem solving, breaking down complex technical and operational challenges into well-thought-out plans
• You like building structure and scalable frameworks that help cross-functional teams execute efficiently
• You proactively identify risks and roadblocks, communicate tradeoffs, and know when and how to elevate
• You’re willing to try, learn, and iterate to keep programs moving forward and partners aligned

This role requires:

• B.Sc. in Biochemistry, Chemical/Biochemical Engineering, or a related field, with 6-8+ years of experience or a MS w/3-6+, including demonstrated ownership of cross-functional deliverables
• A strong customer-service mindset
• Ability to independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes

Preferred / nice-to-haves:

• Experience supporting CMC development and/or technology transfer to CDMOs (e.g., process development, analytics, documentation readiness)
• Experience or knowledge of bioconjugation, gene therapy/AAV, or

#pmpd

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/. For other locations, additional information will be provided during the recruitment process.

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)

$93,900.00 - $153,300.00