Jatin Vaghasiya
Senior Project Manager, Cmc @Sabin Vaccine Institute
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WORK HISTORY
Senior Project Manager, Cmc @Sabin Vaccine Institute
Washington, DC, US
EDUCATION
Indukaka Ipcowala College of Pharmacy
Bachelor of Pharmacy, Pharmacy
Northeastern University
Master of Science in Project Management
ABOUT JATIN VAGHASIYA
I help biotech and pharma companies navigate CMC complexity from Phase 1 IND through commercial launch, integrating regulatory strategy, CDMO networks, and cross-functional execution that turns scientific breakthroughs into approved therapies.Over 10 years leading CMC programs for biologics, viral vector vaccines, and small molecules. I\'ve supported 20+ global submissions (IND, BLA, NDA, MAA, IMPD, EUA, WHO PQ) to FDA, EMA, PMDA, Health Canada, TGA, WHO, managing Phase 1/2 CTM through Phase 3 scale-up, EUA supply, and commercial launch across 15+ countries. CORE EXPERTISE:CMC Operations: Drug Substance/Drug Product development, analytical validation, tech transfer, PPQ, process validation, CDMO governance, manufacturing scale-up, GMP/GDP complianceRegulatory Support: IND/BLA/NDA/EUA submissions, eCTD Module 3, Content/Document Plans, FDA/EMA/PMDA interactions, ICH Q8-Q12, post-approval lifecycle (PACMP)Program Leadership: IPT leadership across 12+ disciplines (Clinical, Regulatory, CMC, QA, Commercial, Manufacturing, Supply Chain), RACI/RAID governance DIGITAL INNOVATION & Artificial Intelligence (AI):I build systems that make CMC operations faster and audit-ready:• Portfolio Dashboard: Smartsheet/Power BI integration auto-connecting batch data to real-time milestones. Eliminated 40hrs/month manual work.• Predictive Risk Model: AI framework identifying CTM/PPQ/regulatory risks 2-3 weeks early with automated mitigations.• Module 3 Drafting Tool: AI-assisted generator creating first-draft CMC sections. Reduced writer workload 60%, accelerated BLA 6 weeks.• Knowledge System: Converted submission insights into reusable playbooks and CTD templates. IMPACT: Directed CMC for NVX-CoV2373: 20+ submissions (FDA/EMA/WHO), enabled COVAX supply (1.1B doses) Managed 8 concurrent CDMO sites across DS/DP/analytical ensuring GMP compliance Led Phase 1/2 CTM → Phase 3 PPQ → EUA → commercial launch across 5 CDMOs Currently leading Phase 2-3 viral vector vaccines TOOLS:Smartsheet, MS Project, Power BI, Veeva Vault, SharePoint, Excel, EVM
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