Jill A. Myers
Ph.D.
Manufacturing and Process Development
Jill serves our clients in the area of manufacturing and process development. She has been consulting since 2005 and has over 20 years of biopharmaceutical experience, including positions at Abbott Laboratories, Repligen, Biogen (now Biogen Idec), Applied Molecular Evolution (AME), and Eli Lilly. She has designed preclinical, clinical, and commercial-phase production purification processes and has been involved in pre- and post-approval strategies and technical discussions and submissions. She has experience starting a successful process development/production function from scratch at a small biotechnology company.
Her experience enables her to design, evaluate, optimize, or troubleshoot purification processes and associated work (including viral clearance studies), assist in technology transfer (in-house or to a CMO), prepare “request for proposals” (RFPs) for contract manufacturing operations (CMOs) and evaluate, manage or work with CMOs. She also has experience in writing, editing, and reviewing Chemistry, Manufacturing and Controls (CMC) sections of regulatory submissions, responses to CMC agency questions, and technical reports.
Jill was a postdoctoral fellow at Harvard Medical School and holds a Ph.D. in Biochemistry from UCLA and a B.S. in Chemistry from University of California, Santa Barbara. She sits on the Recovery of Biological Products Conference Governing Board, the Parenteral Drug Association (PDA) Biotechnology Advisory Board and is the PDA biotechnology interest group leader.
If you need more assistance in determining which of our experienced consultants might best fit your needs, please contact us.
