Sr Scientist, Purification Process Development (Pivotal & Commercial)
Core
Leading purification process development, characterization, and technology transfer for biologics during pivotal (Phase II/III) and commercial phases.
Role type
Senior Scientist, Purification Process Development (Pivotal & Commercial)
Builds
Purification processes for biologics therapies
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Chromatography, Tangential Flow Filtration (TFF), Virus Filtration, Harvest, Virus Clearance, Process Characterization, Statistical Analysis, Design of Experiments (DoE), GMP Documentation, Technology Transfer, Process Scalability, Risk Management
Preferred skills
CMC Regulatory Filings (BLA/MAA), Lab Automation, Data Management, Cross-functional Collaboration
Technologies
JMP, Spotfire
Responsibilities
Design experiments for purification process development; Lead process characterization strategy and execution; Support technology transfer and clinical resupply; Perform statistical analysis for process parameter criticality; Author GMP and non-GMP technical documents; Represent department on cross-functional CMC teams; Mentor junior team members
Seniority
Senior, hands-on IC with potential management responsibilities