Sumit Goswami
Leader at Pharmaceutical development, Tech transfer and Commercial operation (MS&T)
- Role
- Associate Director External Manufacturing Ms & T- Biologics Dp at Bristol Myers Squibb
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Sumit Goswami
Leader with 12+ years of experience of formulation/process development of biologics sterile products (vaccine, mAb, ADC, oncolytic virus), manufacturing (clinical & commercial), technology transfer, process validation. Leader of external manufacturing (ExM) parenteral MS & T global team, advancing global supply and life cycle management of 10+ commercial products of BMS at 5+ CMOs. Leadership of cross-functional team (DS/API, analytical, regulatory, QA, supply chain, MS & T) driving technical brand strategy of commercial product. Leadership of early/late-stage formulation and process development of vaccines (multivalent: glycoconjugate, subunit Ag) DP in liquid, and lyophilized dosage form and alum-based adjuvant in liquid suspension dosage form- presented in vial and prefilled syringe (PFS). Scale up and technology transfer to CMO and internal manufacturing sites and commercial manufacturing at CMO. Key competencies include: Colleague development Technology transfer (scale up), process validation, and aseptic manufacturing at internal site and CMOs (liquid & lyo) Commercial manufacturing investigation support and change control management Formulation and process development for biologics Development of liquid and lyophilized DP Regulatory filing- author/review of IND, BLA, APQR sections New technology evaluation & due diligence on potential asset for in-licensing and product divestiture
Experience
Associate Director External Manufacturing Ms & T- Biologics Dp
Oct 2020 — Present · New Brunswick, NJ, US
Led (interim) parenteral ExM MS & T global team (>20 colleagues) o Commercial supply and life cycle management of 13 commercial products o Management of global commercial manufacturing operation at 6 CMOs • Established MS & T team supporting manufacturing and commercial launch and supply of Opdualag™ - first commercial launch from CMO • Led technical life cycle of Abraxane (Paclitaxel-Albumin nanoparticle) commercial product o Governance of a cross-functional team (DS/API, analytical, regulatory, QA, supply chain, MS & T) o Technical strategy lead for the brand, ensuring stakeholder endorsement and execution • Annex-1 gap assessment and oversight of PUPSIT strategy (internal and external site) • Parenteral product divestiture experience
Education
Jadavpur University
B.Pharm, Pharmaceutical Technology
1997 — 2001
University of Tennessee-Knoxville
PhD, Biochemistry, Biophysics, Cell biology
2003 — 2010
Jadavpur University
M.Tech, Biotechnology
2001 — 2003
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