Process Development Engineer II, Upstream Development - Gene Therapy

Regeneron Pharmaceuticals • Tarrytown, GA

2d • $95,800 - $156,400 • Onsite

About The Position

Regeneron is seeking a highly motivated Process Development Engineer II to join its Preclinical Manufacturing and Process Development (PMPD) group and support upstream manufacturing process development. The role works with a multifunctional team to develop Adeno-Associated Virus (AAV) manufacturing processes and products for gene therapy programs addressing unmet medical needs. It offers work across a range of production scales, from 200 mL to 500 L, and across the development lifecycle, from research through clinical development, regulatory filing, and approval. The position is on-site in Tarrytown, New York, and is full-time. Periodically, it requires short-duration physical exertion, including light-to-medium weight lifting.

Requirements

• Bachelor’s degree with 6–8+ years of relevant experience, or Master’s degree with 4–6+ years of relevant experience, in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field.
• Solid experience with HEK mammalian cell culture and AAV-based gene therapy vector production.
• High self-motivation and proactiveness, with strong initiative and drive to set challenging goals.
• Strong experimental, analytical, and communication skills.
• Coachability, self-awareness, a growth mindset, and willingness to learn from experience, embrace constructive feedback, and develop new skills.
• Adaptability to a dynamic pipeline and changing priorities; ability to manage multiple tasks, work with incomplete information, and contribute independently and collaboratively.

Nice To Haves

• History of developing upstream steps within bioprocesses; experience with bioreactor scale-up and manufacturing technology transfer is preferred.
• JMP experience is preferred.
• Lentiviral vector production experience is a plus.
• Experience with systems such as BioProfile FLEX2, AMBR250 bioreactors, benchtop bioreactors, single-use pilot-scale bioreactors (50–500 L), wave rockers, biosafety cabinets, incubators, autoclaves, Pi Historian, JMP, and Benchling is preferred.

Responsibilities

• Design optimized, well-characterized, robust seed train and bioreactor processes for upstream viral vector production in suspension cell lines, suitable for future GMP clinical and commercial production.
• Lead the design and execution of studies to optimize transfection, bioreactor, and scale-up parameters for viral production using multivariate design-of-experiments approaches.
• Serve as an upstream subject matter expert and lead technology transfer to clinical manufacturing for future gene therapy programs.
• Conduct technology development studies to improve process understanding and viral vector production, including novel reagent screening and equipment evaluation, plasmid system improvements, stable producer cell line process development, and perfusion process development.
• Support development of a next-generation suspension lentiviral vector production process in collaboration with Regeneron Cell Medicine colleagues.
• Lead and support ongoing data management initiatives within the team.
• Design experiments, statistically interpret results, accurately document development data, and clearly present findings to diverse audiences.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level