Director, Quality Control Chemistry & Raw Materials
Core
Lead start-up and operational management of chemistry and raw materials testing for biologics and ADCs at a new biotech manufacturing site.
Role type
Director, Quality Control Chemistry & Raw Materials
Builds
High potent biologics, Antibody Drug Conjugates (ADCs), and raw materials for global supply
Domain
Biotechnology / Pharmaceutical Manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical Instrumentation, Analytical Method Transfer, Biochemistry, Chemical Analysis, Chemistry, Chromatography, Good Manufacturing Practices (GMP), Laboratory Operations, Laboratory Setup, Laboratory Techniques, Microbiological Analysis, Process Chemistry, Process Testing, Quality Control Systems, Raw Material Analysis, Separation Techniques
Preferred skills
ADC experience, Regulatory Inspection Experience, Digital Tools, Laboratory Automation
Technologies
Chromatography, Digital Tools, Laboratory Automation
Responsibilities
Lead laboratory start-up (design, commissioning, validation), manage day-to-day QC operations for separations and raw materials, oversee method lifecycle management, lead OOS/OOT investigations, manage departmental budgets, build and lead analytical teams
Seniority
Director, strategic & operational leadership
