Senior Scientist, Process Development
Core
Lead the development, scale-up, characterization, and technology transfer of biologics drug substance purification processes from harvest to final drug substance.
Role type
Senior Scientist, Process Development (Biologics Purification)
Builds
Robust, scalable, and manufacturable biologics purification processes for pivotal and commercial programs.
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Biologics purification process development, chromatography, virus inactivation, virus filtration, ultrafiltration/diafiltration, formulation, final filtration, Design of Experiments, process scale-up, technology transfer, GMP manufacturing execution, process characterization, operating range establishment, CMC regulatory content authoring, technical writing, project leadership, risk management, troubleshooting, mentorship.
Preferred skills
Experience leading drug substance technology transfers to internal sites and external partners/CDMOs, supporting engineering/clinical/commercial campaigns, developing process control strategies, qualifying scale-down models, authoring CMC regulatory filings.
Technologies
Chromatography systems, filtration systems (virus, ultrafiltration), formulation equipment, statistical analysis tools, LIMS (implied via study protocols/batch records), GMP manufacturing facilities.
Responsibilities
Provide scientific direction and identify technical risks for purification programs; lead technology-transfer workstreams to internal and external manufacturing sites; design and execute process characterization and scale-down studies; establish operating ranges and process control strategies; support GMP manufacturing campaigns including on-site and person-in-plant support; lead troubleshooting and root-cause assessments; author development reports, protocols, SOPs, and CMC regulatory content; mentor junior scientists; travel to support technology transfers.
Seniority
Senior, hands-on IC with technical leadership
