Vilma Jimenez
Director, CMC Analytical Strategy Bayer
Vilma Jimenez is Director of CMC Analytical Strategy for Cell Therapy at Bayer, based at the company’s biotechnology and cell therapy hub in Berkeley. She leads analytical strategy supporting late-stage development, launch readiness, and commercialization of advanced cell therapies. Her work spans analytical assay development, method transfers, and product characterization, with a strong focus on comparability as programs transition from development to commercial manufacturing. Vilma collaborates cross-functionally with process development, manufacturing, MSAT, and formulation teams to address evolving regulatory expectations and ensure robust analytical control strategies for emerging cell therapy products.
Seminars
- Initiating early product and process lifecycle mapping to identify optimal timing for changes while leveraging FDA guidelines emphasizing flexibility in early phases versus stringent late-stage expectations
- Implementing robust statistical justification strategies and collaborating with statisticians to overcome analytical challenges and support regulatory-compliant comparability assessments
- Applying risk management frameworks in stepwise approaches to tackle potential showstoppers early and facilitate smoother transitions throughout process development activities
