Process Development Engineer
Core
Coordinate complex non-routine activities including tech transfer, process qualification, performance monitoring, and floor support for biopharmaceutical manufacturing.
Role type
Process Development Engineer (Biopharmaceutical Manufacturing)
Builds
Commercial biopharmaceutical products via cell culture processes
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
cell culture process knowledge, single-use technologies, harvest technologies, cGMP compliance, unit operations troubleshooting, statistical analysis, engineering principles, technical writing, problem solving
Preferred skills
advanced statistical analysis, hypothesis development, creative problem solving
Technologies
Excel, JMP, SIMCA
Responsibilities
Coordinate tech transfer and process qualification, support/lead investigations, compile and analyze process data, author technical protocols and assessments, verify data for regulatory filings, provide floor support and resolve unit operation issues
Seniority
Mid-Senior, hands-on IC