Process Development Associate, Bioreactor and Scale-Up Development (1 of 2)

Role Summary

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. 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

• BS or MS in Chemical Engineering or Bio-related Engineering with 0–3 years of laboratory experience. 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 is a plus.
• Please clearly state GPA on CV.

Skills

• Strong initiative and ability to work independently and in teams on multiple projects
• Lab equipment maintenance and safety awareness
• Strong analytical, computer, and technical writing skills