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

Regeneron PharmaceuticalsTarrytown, GA
Onsite

About The Position

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. This representative will work in the Advanced Therapy Project Management (AT-PM) group within Product, Analytical, and Process Development Operations (PAPD Ops) to help drive successful development and tech transfer of advanced therapies (e.g., AAV, bioconjugates, and synthetic chemistry programs) by enabling clear cross-functional ways of working, disciplined planning, and operational excellence with our internal partners and Contract Development & Manufacturing Organizations (CDMOs).

Requirements

  • B.Sc. with 5+ years, or M.Sc. with 3+ years of biochemistry/chemical/biochemical engineering or a related field.
  • Demonstrated ownership of cross-functional deliverables.
  • Strong customer-service mindset.
  • Ability to independently facilitate team collaboration.
  • Ability to build and maintain integrated plans.
  • Ability to design/improve repeatable business processes.

Nice To Haves

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

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).

Benefits

  • Health and wellness programs (including medical, dental, vision, life, and disability insurance)
  • Fitness centers
  • 401(k) company match
  • Family support benefits
  • Equity awards
  • Annual bonuses
  • Paid time off
  • Paid leaves (e.g., military and parental leave)
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