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
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for…