Principal Scientist, Cell Therapy Process Development | Alabaster, AL

You will have the opportunity to establish manufacturing platforms and guide product development through all stages of development to ensure project advancement. This role is based in Florham Park, NJ In this role a typical day may include: Independently design studies aimed at optimizing and improving expansion and manufacturability of candidate products based on the biology and the target.

Design and execute experiments using approaches such as DOE or QBD, maintain detailed records of results, and present results to multi-disciplinary teams and leadership. Apply DOE/DQB for process characterization, establish process parameters, and contribute to CMC sections of regulatory filings.

Develop cell isolation, enrichment, separation and formulation protocols and technologies/ platforms to support product development. Develop processes that integrate innovative approaches to increase the functional capability and yield of gd T cells.

Relying on an in-depth CAR-T background, perform statistical analyses using product attribute data to assist, guide, and execute comparability studies. Develop and oversee tech transfer of protocols to CDMO. Collaborate with SME(s) at CDMOs to deliver timely and accurate technical solutions to resolve investigations and improve manufacturing performance and reliability. Present experimental outcomes, process analytics, and data trends to

larger cross functional groups and leadership. T his role may be for you if you: Enjoy the challenge of developing and improving processes for CAR-T manufacture.

Desire an opportunity to make key and highly visible contributions. Have a sound understanding in various approaches for CAR-T manufacture. Enjoy working in a matrix environment and guiding collaborations. To be considered for this role, you must have a Ph. D. + 6 years in immunology or bioengineering discipline with relevant industry experience, including cell therapy process development. We need someone with extensive hands-on experience in cell culture (primary cells and cell lines), aseptic culture, as well as genetic modification of cells using transduction and/or transfection.

Experience with gamma delta and other T cell lineages is needed. Experience in establishing cell therapy manufacturing processes and improving scalable upstream processes in the PD setting is required. Experience using wave rocker systems, benchtop bioreactors, Sepax, LOVO, and closed harvest systems will be needed. Familiarity with flow cytometry assays and other cell-based characterization assays (i. e. cytokine release and cytolytic assays) is a plus. Proven experience in the transfer of technologies/processes.

Demonstrated capability to conduct/document complex manufacturing processes, familiarity with FDA guidance's, and an understanding of GMP GDP/quality is preferred. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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), interaction, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, interactionual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.

Please contact us to discuss any accommodations you think you may need. The salary ranges provided are shown in accordance with U. S. law and apply to U. S. based positions, where the hired candidate will be located in the U. S. If you are outside the U. S, please speak with your recruiter about salaries and benefits in your location. Salary Range (annually) $121,200.00 - $197,800.00