Process Development Associate, PAPD Operations
RegeneronAbout the role
Regeneron, located in Tarrytown, NY, is seeking a Process Development Associate 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).
A Typical Day in This Role Might Look Like:
Lead cross-functional teams to complete process transfer and establish production processes at Contract Development & Manufacturing Organizations (CDMOs). Help ensure successful start-up and execution of manufacturing campaigns by driving team alignment, tracking deliverables, and escalating risks/issues as needed.
Own effective, accurate, and timely communication across functional areas within project/program teams. Serve as a primary point of contact for project status, decisions, and next steps, ensuring stakeholders have clear visibility to scope, timelines, and key risks.
Build and maintain integrated timelines for development and transfer activities, including assumptions, dependencies, and critical path.
Anticipate and address risks to manufacturing readiness related to process, documentation, training, and supply/logistics.
Lead recurring and ad-hoc technical forums to troubleshoot issues, drive decision-making, and capture lessons learned to improve future development and tech transfers across modalities.
Contribute to continuous improvement efforts to streamline and standardize AT-PM ways of working (templates, trackers, dashboards, and reference guides).
Partner with procurement and internal stakeholders to support CDMO engagement activities (e.g., RFPs, contracting coordination, and invoices) and help maintain a healthy vendor network to meet pipeline capacity/capability needs.
This Role Might Be For You If:
You take initiative, follow through on commitments, and enjoy working in a fast-moving environment with evolving priorities.
You enjoy coordinating across functions (technical and non-technical) and can balance independent work with team-based execution across multiple projects.
You have strong planning and organizational skills and are comfortable leading meetings, aligning on next steps, and driving closure on open actions.
You proactively identify risks/roadblocks, communicate tradeoffs, and know when and how to escalate to keep programs on track while maintaining strong partner relationships.
This role requires a BS in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Biochemistry, Biology, or Chemistry with an interest in Operations, Project Management, and Business, and 0–2 years of relevant experience in the biotechnology or pharmaceutical industry (internship/co-op experience may be considered). A strong customer-service mindset is essential. The ideal candidate can facilitate team collaboration, build and maintain clear project plans, and help design and improve repeatable business processes. Familiarity with cross-functional CMC concepts (e.g., process development, analytics, documentation readiness, and tech transfer to CDMOs) is preferred. Prior experience or knowledge of bioconjugation, gene therapy/AAV, or related advanced therapy process development is a plus.
If applicable, candidates may include GPA on their resume.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role an
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