Summary

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a highly motivated Process Development Engineer II to join our Preclinical Manufacturing and Process Development (PMPD) group, responsible for upstream development efforts to support manufacturing process development functions. In this role, you will work as part of a multi-functional team to provide Adeno-Associated Virus (AAV) manufacturing processes and products with the aim of providing treatment to unmet medical needs through gene therapy. This is a growth opportunity that combines the excitement and opportunity of a start-up with the security and institutional knowledge gained from working for a larger firm. You will have the unique opportunity to work on production processes across a wide range of scales from 200 mL to 500 L, and support programs across the development lifecycle, from research through clinical development, regulatory filing, and approval.

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 highly motivated Process Development Engineer II to join our Preclinical Manufacturing and Process Development (PMPD) group, responsible for upstream development efforts to support manufacturing process development functions. In this role, you will work as part of a multi-functional team to provide Adeno-Associated Virus (AAV) manufacturing processes and products with the aim of providing treatment to unmet medical needs through gene therapy. This is a growth opportunity that combines the excitement and opportunity of a start-up with the security and institutional knowledge gained from working for a larger firm. You will have the unique opportunity to work on production processes across a wide range of scales from 200 mL to 500 L, and support programs across the development lifecycle, from research through clinical development, regulatory filing, and approval.

When & where

Shift Requirements: Full-time
Location: On-site in Tarrytown, NY
Other requirements: Job will periodically require short duration physical exertions, including light-medium weight lifting

Discover your role

Design optimized, well-characterized, and 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 experiment approaches
Serve as an upstream subject matter expert and lead technology transfer to clinical manufacturing for future gene therapy programs
Conduct technology development studies aimed at enhancing process understanding and improving viral vector production, including novel reagent screening and equipment evaluation, plasmid system improvements, stable producer cell line process development, and perfusion process development
Support the 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

This role requires

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
A history of developing upstream steps within bioprocesses; experience with bioreactor scale-up and manufacturing technology transfer is preferred
JMP experience preferred; lentiviral vector production experience is a plus
Proven experience with some of the following systems is preferred: BioProfile FLEX2, AMBR250 bioreactors, bench top bioreactors, single-use pilot scale bioreactors (50-500 L), wave rockers, biosafety cabinets, incubators, autoclave, Pi Historian, JMP, Benchling
High self-motivation and proactiveness, with strong initiative and drive to set challenging goals
Strong experimental, analytical, and communication skills, with the ability to design experiments, statistically interpret results, accurately document development data, and clearly present findings to diverse audiences
Coachability, self-awareness, and a growth mindset, with a willingness to learn from experience, embrace constructive feedback, and develop new skills
Adaptability to a dynamic pipeline and priorities, with the ability to manage multiple tasks, work effectively with incomplete information, and contribute both independently and collaboratively

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
A history of developing upstream steps within bioprocesses
Experience with bioreactor scale-up and manufacturing technology transfer is preferred
JMP experience preferred
Lentiviral vector production experience is a plus
Proven experience with some of the following systems is preferred: BioProfile FLEX2, AMBR250 bioreactors, bench top bioreactors, single-use pilot scale bioreactors (50-500 L), wave rockers, biosafety cabinets, incubators, autoclave, Pi Historian, JMP, Benchling
High self-motivation and proactiveness, with strong initiative and drive to set challenging goals
Strong experimental, analytical, and communication skills, with the ability to design experiments, statistically interpret results, accurately document development data, and clearly present findings to diverse audiences
Coachability, self-awareness, and a growth mindset, with a willingness to learn from experience, embrace constructive feedback, and develop new skills
Adaptability to a dynamic pipeline and priorities, with the ability to manage multiple tasks, work effectively with incomplete information, and contribute both independently and collaboratively

Benefits

Annual bonuses
Incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Insurance benefits
Paid time off
Family support benefits

Company overview

Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.