Senior Manufacturing Associate (Senior Biotechnologist), Day Shift – Large Scale Allogeneic
Core
Senior floor leader and Subject Matter Expert for upstream large-scale allogeneic cell therapy manufacturing, managing automated bioreactor operations and facility launch.
Role type
Senior Manufacturing Associate (Senior Biotechnologist)
Builds
Large-scale allogeneic cell therapy products
Domain
Biotechnology / Cell Therapy / Upstream Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, aseptic processing techniques, single-use bioreactor systems, electronic batch record (EBR) management, SOP/WI authoring, shift leadership, minor deviation investigation, change control initiation
Preferred skills
upstream processing experience, bioreactor inoculation and harvest, TrackWise platform proficiency
Technologies
single-use bioreactor systems, TrackWise, automated unit operations
Responsibilities
Lead upstream manufacturing operations including cell growth, culture maintenance, and product harvest; Execute aseptic setups in Grade B cleanrooms and monitor batches in Grade C; Author and optimize cGMP documentation (EBRs, SOPs, WIs); Mentor junior staff and act as shift supervisor fill-in; Lead minor floor investigations and initiate change controls/CAPAs; Support facility launch with engineering and water runs
Seniority
Senior, hands-on IC with leadership anchor responsibilities