Michelle Gawrys
Senior Director, Cell Therapy External Manufacturing - New Drug Product Program Leader @Bristol Myers Squibb
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WORK HISTORY
Senior Director, Cell Therapy External Manufacturing - New Drug Product Program Leader @Bristol Myers Squibb
Summit, NJ, US
Pioneer use of novel automation technology to deliver fully automated, high-throughput cell therapy manufacturing. Lead team of >20 people (internal and external) to establish new external capacity to expand access to patients globally. • Oversee 10 workstreams for operational readiness, including facility construction across 3 facilities, site readiness for GMP batches, QC method transfer, IT/systems integration, MSAT/Tech Ops, supply chain, logistics, quality systems, and sterility assurance. Ensure successful PPQ/Comparability run execution, regulatory submission, and approval. • Define scale up and capacity ramp strategy to integrate 3 new external commercial supply nodes into existing network. • Build an open, collaborative relationship with the CMO. Institute governance meetings to track performance, proactively manage risks, and drive timely decision-making.
EDUCATION
University of Pennsylvania
Master of Engineering, Bioengineering
The Wharton School
Executive Master of Business Administration (MBA)
Princeton University
BSE, Chemical Engineering
ABOUT MICHELLE GAWRYS
A highly motivated self-starter who enjoys driving results and influencing change in organizations. Proven leader with a demonstrated ability to motivate and transform teams in manufacturing, operations, and business settings. Consistently leverages her engineering background and business degree to encourage teams to conduct strategic problem-solving and develop innovative solutions. Effective and enthusiastic communicator, with experience partnering across divisions. A global biopharmaceutical leader with 16 years of experience across GMSAT (Tech Ops), Operations, Strategic Supply Chain, and External Manufacturing functions. Work experience based in US and Europe, enjoys embracing working across cultures. Experience managing organizations of 40+ staff including union employees, directly responsible for P+L and yearly operational budget of >$30 million. Significant experience in lean/six sigma, biopharmaceutical operations, external partner management, technology transfer, capacity planning, supply chain design, vaccine manufacturing, and sterile filling.
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