Michelle Petkov
Bioassay Development Principal Scientist & CMC Analytical Lead at Bristol Myers Squibb
- Role
- Principal Scientist Cmc Analytical Lead at Bristol Myers Squibb
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Michelle Petkov
Greetings! I am an enthusiastic development scientist currently in the Central New Jersey area. At BMS, I hold the dual roles of a Scientist and a CMC Analytical Lead. As a Scientist in Bioassay Development, I am responsible for assay development, optimization, validation, and testing to support the company’s portfolio of early and late stage clinical biologics. As a CMC Analytical Lead, I provide overall direction to a matrix team to develop and execute a complete analytical control strategy for the advancement of BMS biologic assets.Feel free to reach out if you would like to chat!
Experience
Principal Scientist Cmc Analytical Lead
Jul 2024 — Present
CMC Analytical Lead:* Manage analytical matrix teams to support overall CMC development with input from functional area subject matter experts including disciplines such as compendial methods, biophysical characterization, biological assays, GMP operations, and separations method development.* Represent the entire analytical function in the CMC project team and partner with representatives from key functions such as process development, formulation development, quality, regulatory, manufacturing, and supply chain.* Ensure phase-appropriate method validation and testing is conducted to support product development.* Author, edit, and review sections/documents for regulatory submission including INDs, CTAs, and other regional applications. Respond to health authority queries after filing.Bioassay Development:* Serve as potency point-of-contact and potency subject matter expert on analytical subteams.* Develop, optimize, and validate ELISAs and cell-based potency assays for therapeutic biologics including monoclonal antibodies and fusion proteins.* Execute routine testing for drug characterization and GMP release/stability campaigns.* Insource potency assays for acquired assets and manage external CRO activities.
Education
North Carolina State University
Doctor of Philosophy (Ph.D.), Chemical and Biomolecular Engineering
2016
Princeton University
Bachelor of Science in Engineering (B.S.E.), Chemical and Biological Engineering
2012
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