Ameya Borwankar
Senior Director, Biologics Drug Substance
- Role
- Senior Director, Biologics at Formation Bio
- Location
- South San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Ameya Borwankar
Chemical engineer with 10+ years of experience in biologics drug substance and CMC cross-functional team leadership. Experienced in all aspects of biologics drug substance, scale-up and manufacturing including microbial fermentation, mammalian cell culture, recovery, chromatography, virus filtration, ultrafiltration/diafiltration, protein conjugation, and formulation. Extensive work on process development, process characterization, process validation, tech transfer, clinical and commercial manufacturing SkillsMicrobial fermentation, mammalian cell culture, depth filtration, cell recovery centrifugation, cell disruption, chromatography, membrane filtration, virus filtration, ultrafiltration/diafiltration, protein formulation, protein stability, regulatory authoring, deviation and investigation support, CMC matrix team leadership, CMC strategy, Experience with variety of protein therapeutics (mAbs, fusion proteins, interleukins and others), building high functioning technical teams, cleaning validation, QbD, FMEA
Experience
Senior Director, Biologics
Oct 2025 — Present
Education
The University of Texas at Austin
Doctor of Philosophy (Ph.D.), Chemical Engineering
2009 — 2014
Institute Of Chemical Technology
Bachelor of Engineering (B.E.), Chemical Engineering
2005 — 2009
Skills
- Biochemistry
- Research
- Hplc
- Light Scattering
- Uv/Vis
- Zeta Potential
- Colloids
- Nanotechnology
- Data Analysis
- Chemistry
- R&D
- Uv-Vis-Nir
- Materials Science
- Electron Microscopy
- Scanning Electron Microscopy
- Matlab
- Chemical Engineering
- Rheology
- Tff
- Biotechnology
- Characterization
- Spectroscopy
- Lyophilization
- Nanomaterials
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