Process Development Engineer II, Upstream Development - Gene Therapy

BioSpace; Village of Tarrytown (NY); On-site; USD 96,000 - 156,000; Full time

Job summary

Regeneron is seeking a Process Development Engineer II for its PMPD group in Tarrytown, NY. You will design and optimize seed train and bioreactor processes for AAV production, lead DOE studies, and drive technology transfer to clinical manufacturing for gene therapy programs.

The role requires strong experimental and analytical skills, collaboration across teams, and a proactive growth mindset in a dynamic pipeline environment.

Qualifications

• Bachelor’s or Master’s degree in Chemical/Biochemical Engineering, Biochemistry or related field with 4–8+ years of relevant experience.
• Solid experience with HEK mammalian cell culture and AAV-based gene therapy vector production.
• Experience with bioreactor scale-up and technology transfer preferred.
• JMP experience preferred; lentiviral vector production a plus.
• Proven ability to design experiments and interpret results with clear documentation.

Responsibilities

• Design optimized, well-characterized seed train and bioreactor processes for upstream viral vector production in suspension cell lines, suitable for GMP clinical and commercial production.
• Lead studies to optimize transfection, bioreactor, and scale-up parameters for viral production using multivariate DOE approaches.
• Serve as upstream SME and lead technology transfer to clinical manufacturing for future gene therapy programs.
• Conduct technology development to enhance process understanding, including reagent screening, equipment evaluation, plasmid system improvements, stable producer cell line development, and perfusion process development.
• Support development of next-generation suspension lentiviral vector production in collaboration with Regeneron Cell Medicine colleagues.
• Lead and support ongoing data management initiatives within the team.

Skills

Strong experimental skills

Analytical mindset

Excellent communication

Growth mindset

Team collaboration

Education

Bachelor's or Master's in Chemical Engineering, Biochemical Engineering, Biochemistry or related field

Tools

JMP

Benchling

BioProfile FLEX2

AMBR250 bioreactors

Bench top bioreactors

Single-use pilot scale bioreactors (50-500 L)

Wave rockers

Biosafety cabinets

Incubators

Autoclave

Pi Historian

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

• Bachelors degree with 6-8+ years of relevant experience, or Masters 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?

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 employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

• Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
• For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other locations, additional information will be provided during the recruitment process.
• If you have any questions, please speak with your recruiter.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$95,800.00 - $156,400.00