Role Summary
Regeneron’s Bioreactor and Scale-Up Development Group within Preclinical Manufacturing and Process Development (PMPD) is looking for a motivated Process Development Associate to work as part of the late-stage development team to develop production processes of biologics in a non-GMP process development laboratory. In this role, they will perform studies at pilot scale to develop commercially enabling manufacturing processes.
Responsibilities
- Support lab operations to cultivate mammalian cells producing biologics in bench and pilot-scale bioreactors, including sterilizing, sanitizing, and operating bioreactors, preparing buffers and feeds, and maintaining and onboarding laboratory equipment.
- Contribute to technology development projects to innovate process development and explore personal areas of interest.
- Evaluate and solve challenges associated with the scale-up of processes.
- Analyze seed train, production, and quality data to support process understanding and technology transfer, followed by authoring development reports, process transmittals, and documentation in electronic notebooks.
- Participate in Technology Transfer Start-Up Teams by transferring technology via written reports and providing virtual and on-site support during clinical production campaigns.
- Produce various non-clinical reagents to support Regeneron’s Research and Development activities.
Qualifications
- Required: BS or MS in Chemical Engineering or Bio-related Engineering with 0-2 years of experience in a laboratory setting.
- Preferred: Experience with NOVA FLEX, Sartorius Biostat DCU Bench top Bioreactors, Biobrain Operate, Applikon bench top bioreactors, WAVE bioreactors, ABEC/Hyclone Single Use Bioreactors (50-500L), ABEC Stainless Steel Pilot Scale (40-500L) bioreactors, Medium Prep skid, CIP, Biosafety cabinets, incubators, autoclave, Perfusion Bioreactor, Continuous Processing, SynTQ, PI Historian, JMP, Benchling, Ignition.
- Note: Please clearly state your GPA on your CV.