Technical Group Leader, Upstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc.
Core
Lead upstream process development from small-scale experiments to pilot-scale operations and technology transfer into GMP manufacturing for biologics.
Role type
Senior Technical Group Leader, Upstream Biologics
Builds
Upstream bioprocessing processes and cell culture operations for clinical and commercial production
Domain
Biopharmaceuticals / Biologics CDMO
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mammalian cell culture, upstream bioprocessing, scale-up design, technology transfer, aseptic techniques, GMP compliance, process development, team leadership, RCA/CAPA, SOP drafting
Preferred skills
experience managing technologists, cross-functional collaboration, problem-solving
Technologies
SU bioreactors, shaker incubators, cell counters, peristaltic pumps, mixers, depth filtration systems, sterile filtration systems
Responsibilities
Execute and oversee small- and pilot-scale upstream PD experiments including seed expansion and bioreactor operations. Operate and maintain key upstream equipment and perform harvests and filtrations. Lead technology transfer, scale-up designs, and scientific reporting. Author batch records, SOPs, and CQV protocols. Lead RCA investigations for process deviations and drive CAPA execution. Oversee GMP upstream manufacturing activities and supervise floor operations.
Seniority
Senior, hands-on IC with leadership responsibilities