Senior Director, Biopharmaceutical Drug Substance Process Development
GSK
Pennsylvania, United States
Biopharmaceutical drug substance development
Cell culture and purification science
Process development and scale-up
Lead a team of approximately 100 cell culture and purification scientists responsible for end-to-end biopharm drug substance process development, characterization, and tech transfer
Job Summary
Lead a team of approximately 100 cell culture and purification scientists responsible for end-to-end biopharm drug substance process development, characterization, and tech transfer.
Drive process characterization and validation strategies aligned with regulatory expectations and lifecycle plans, with accountability for development activities leveraging internal and external capacity.
Foster a high-performance culture, identify and develop talent, and establish sound succession plans while collaborating effectively across internal and external partners.
Matching Summary
Lead a team of approximately 100 cell culture and purification scientists responsible for end-to-end biopharm drug substance process development, characterization, and tech transfer.
Skills & Requirements
Must-have
Biopharmaceutical drug substance development
Cell culture and purification science
Process development and scale-up
Technology transfer to GMP sites
CMC regulatory submissions
High-performance culture development
Nice-to-have
Emerging innovation industrialization
Cross-functional partnership
Strategic external development partners
Predict, Design, Execute mindset
Data integrity assurance
Safe working practices implementation
Key Requirements
Bachelor's/Master's degree with 15+ years experience or PhD with 10+ years experience
10+ years leading CMC projects
10+ years leading end-to-end medicine and vaccine CMC process development
Experience leading lab-based process development teams > 50 FTE
Experience representing company to external organizations