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

About the role

Regeneron, located in Tarrytown, NY, is seeking a Process Development Engineer II to support project management, technology transfer, and business operations for Regeneron Advanced Therapy Programs.

Responsibilities

• Lead cross-functional tech transfer teams and independently own workstreams to establish production processes at CDMOs.
• Drive readiness for manufacturing start-up and execution by clarifying scope, securing inputs/approvals, tracking deliverables, and escalating risks/issues with proposed mitigations.
• Own communication strategy and operating cadence for assigned programs (e.g., core team meetings, technical forums, and stakeholder updates).
• Provide concise, decision-ready status reporting (scope/timeline/cost/risk) tailored to different audiences, including senior stakeholders.
• Build, maintain, and continuously improve integrated plans across development and transfer activities.
• Facilitate scenario planning and tradeoff discussions to protect key milestones and support portfolio-level prioritization.
• Anticipate and address risks to manufacturing readiness related to process. Define mitigation plans and help ensure teams execute with rigor expected for successful CDMO campaign execution.
• Lead recurring and ad-hoc technical forums to drive timely decisions, resolve issues, and capture lessons learned.
• Translate learnings into tools to improve repeatability across modalities and CDMOs.
• Lead continuous improvement initiatives to mature AT-PM ways of working.
• Partner with procurement, finance, legal, and internal stakeholders to support CDMO engagement (RFPs, scope alignment, contracting coordination, and invoice tracking).

Requirements

• B.Sc., with 5+ years of biochemistry/chemical/biochemical engineering or a related field, or M.Sc., with 3+ years of biochemistry/chemical/biochemical engineering or a related field.
• Demonstrated ownership of cross-functional deliverables.
• A strong customer-service mindset is essential.
• The ideal candidate can independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes.
• Experience supporting CMC development and/or technology transfer to CDMOs (e.g., process development, analytics, documentation readiness) is preferred.
• Prior experience or knowledge of bioconjugation, gene therapy/AAV, or related advanced therapy process development is a plus.

Qualifications

• Proactive identification of risks/roadblocks, communication of tradeoffs, and escalation of issues when necessary.
• Willingness to try, learn, and iterate to keep programs moving forward and partners aligned.

Skills

• Strategic mindset.
• Action-oriented approach.
• Energy.
• Problem-solving ability.
• Ability to build and maintain integrated plans.
• Design and improve repeatable business processes.

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 here.

Pay

$93,900.00 - $153,300.00 annually

Schedule

Full-time