Sr Scientist, Purification Process Development (Pivotal & Commercial)
Core
Leading purification process development, characterization, and technology transfer for biologics during pivotal phases (II/III) and post-launch.
Role type
Senior Scientist, Purification Process Development (Pivotal & Commercial)
Builds
Purification processes for biologics programs
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, Risk Management
Preferred skills
Pivotal stage GMP facility experience, 2-25 kL scale technology transfer, CMC regulatory filing experience, Lab automation, Data science
Technologies
JMP, Spotfire
Responsibilities
Design experiments for purification development; Lead process characterization and optimization; Support technology transfer and clinical resupply; Author GMP/non-GMP regulatory documents; Represent department on cross-functional CMC teams; Mentor junior team members.
Seniority
Senior, hands-on IC with potential management
