Process Development Engineering Principal Associate
Core
Lead Manufacturing Science and Technology (MSAT) activities for cell therapy products, managing technology development, transfer, and process performance qualification.
Role type
Principal Associate, Process Development Engineering
Builds
Clinical and commercial manufacturing processes for cell therapy products
Domain
Biotechnology / Cell Therapy / Manufacturing Science and Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
MSAT investigation and change management, cell processing (primary cells), Design Control, Risk Management (FMEA), regulatory submission support, CDMO oversight, process lifecycle management
Preferred skills
Cell-gene therapy development experience, late phase clinical/commercial experience
Technologies
FMEA, IND, IMPD
Responsibilities
Lead triage, investigation, and change control implementation; Manage execution of deliverables via milestones and timelines; Contribute to regulatory submissions (IND, IMPD); Coordinate cross-functional activities; Drive continuous improvement and operational excellence; Support pre-PPQ and PPQ activities; Establish robust process performance across manufacturing lines; Oversee CDMO activities
Seniority
Senior, hands-on IC
