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

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

Job summary

Regeneron is seeking a Process Development Associate to join the Advanced Therapy Project Management group within PAPD Ops in an on-site capacity at our Tarrytown, NY location. You will support project management, tech transfer, and business operations for Regeneron's Advanced Therapy Programs, collaborating with internal teams and CDMOs to enable efficient cross-functional execution.

You will lead cross-functional tech transfer teams, clarify scope, track deliverables, manage communications,

Qualifications

• Cross-functional ownership of deliverables in complex programs.
• Ability to facilitate team collaboration and develop repeatable business processes.
• Customer-service mindset and proactive problem solving.

Responsibilities

• Lead cross-functional tech transfer teams and own workstreams at CDMOs.
• Clarify scope, secure inputs and approvals, track deliverables, escalate risks with mitigations.
• Own communication strategy and status reporting for programs to stakeholders.
• Build and maintain integrated plans across development and transfer activities.
• Address risks to manufacturing readiness and define mitigation plans.
• Lead technical forums to drive timely decisions and capture lessons learned.

Skills

Cross-functional collaboration

Project management

Communication strategy

Education

BSc in Biochemistry or Chemical/Biochemical Engineering

MS with 3–6+ years experience

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.

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.

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

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.

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)

$93,900.00 - $153,300.00

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. If you have any questions, please speak with your recruiter.