Process Engineer MS&T
Core
Lead technology transfer, new product introduction, and lifecycle management for autologous and allogeneic cell therapies in a cGMP manufacturing facility.
Role type
Senior IC process engineer (cell therapy manufacturing)
Builds
Safe, high-quality cell-based therapies for commercialization
Domain
Biopharmaceuticals / Cell & Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, process validation, fit-gap analysis, root cause investigation, statistical data analysis, equipment qualification, regulatory documentation
Preferred skills
cell culturing (T-Flask, G-REX), autoclave operation, facility start-up and licensure, data historian/DCS systems
Technologies
Data Historian, Distributed Control Systems, Microsoft Office
Responsibilities
Lead technology transfer and new product introduction activities; Author and approve cGMP technical documentation including batch records and SOPs; Lead process validation activities including PPQ support; Provide hands-on manufacturing support for troubleshooting and deviation management; Analyze manufacturing data to support process improvements; Partner with cross-functional teams for equipment implementation and operational readiness.
Seniority
Senior, hands-on IC