Bhavik M.
Vaccine Process Development & Manufacturing Director @Gates Medical Research Institute
Signup · Get unlimited contacts
WORK HISTORY
Vaccine Process Development & Manufacturing Director @Gates Medical Research Institute
Cambridge, MA, US
Serve as DS Lead for the M72 TB vaccine Phase 3 program, coordinating process development, tech transfer and GMP manufacturing campaigns across global CDMO, overseeing process robustness studies and PPQ readiness toward first regulatory approval.· Primary author for upcoming MAA submission across EMA and LMIC frameworks, translating complex CMC data into submission-ready Module 3 documentation. Authored briefing book sections for EMA Scientific Advice Meeting
EDUCATION
University of Rajasthan
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
Institute Of Chemical Technology
Master of Science (Technology), Bioprocess Technology
Western University
Doctor of Philosophy (Ph.D.), Biochemical Engineering
SKILLS
ABOUT BHAVIK M.
Driving portfolio advancement, manufacturing strategy, and regulatory execution across biologics and vaccines, from first in human through global registration · 16+ years building and executing end-to-end CMC programs across big pharma, venture backed biotech, early-stage startup, and global health nonprofit · Seven modality platforms: monoclonal antibodies, bispecific antibodies, recombinant proteins, cyclic peptide conjugates, oligonucleotide conjugates, DNA vaccines, multivalent vaccines · Leading DS development strategy for the M72/AS01E tuberculosis vaccine from Phase 3 through commercial tech transfer · Advanced a bispecific antibody from IND through Phase 1 with zero FDA CMC questions at filing · Led Process characterization work supporting the Entyvio SC (vedolizumab) BLA submission · Scaled a first-in-class protein x cyclic peptide conjugate for MNGIE to 500L GMP manufacturing · CDMO selection, tech transfer, site readiness diligence, and technical governance of contract manufacturers through clinical campaigns globally · Building teams and governance structures that hold CDMOs accountable as true technical partners, not vendors · Authored and reviewed Module 3 for IND, BLA, MAA and scientific advice briefing document; drafted and reviewed formal response to HA · Rigorous CMC execution is what gets promising science to patients.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.