Bachelor's degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or a related scientific discipline required
Minimum of 10 years of relevant, progressive experience in the pharmaceutical, biotechnology, or biopharmaceutical industry, with substantial experience in GMP Quality Control laboratories.
Minimum of five years of direct people-management experience
Strong experience supporting biologics or biotherapeutics
Broad knowledge of analytical and microbiological laboratory operations, analytical method lifecycle activities, laboratory investigations, data review, statistical trending, electronic laboratory systems, sample management, and equipment lifecycle management.
Strong working knowledge of applicable FDA, EMA, ICH, pharmacopeial, and global cGMP expectations for biologics and advanced therapy products.
Proven success managing multi-site operations, operating and capital budgets, laboratory capacity, competing priorities, organizational change, and complex cross-functional initiatives.
The incumbent must be able to work in laboratory and manufacturing environments and comply with applicable gowning, personal protective equipment, health, safety, and site-access requirements.