Jatin Vaghasiya — Senior CMC Program Leader & AI Systems Builder
Senior CMC program leader and AI systems builder with 10+ years across vaccine, biologics, and small molecule programs. Leads CMC execution from IND through BLA, commercial launch, and post-approval lifecycle across FDA, EMA, WHO PQ, and 20+ regulatory jurisdictions. Builds AI-enabled operating tools, dashboards, risk engines, and decision platforms from direct program experience.
Current role: Senior Project Manager, CMC (Contract) at Sabin Vaccine Institute — Phase 2–3 vaccine programs, tech transfer, health authority readiness.
Experience
Sabin Vaccine Institute — Senior Project Manager, CMC (Contract) · Sep 2025–Present
Leading vaccine programs through Phase 2–3 with emphasis on CMC strategy, filing planning, tech transfer, and health authority readiness. ICH-aligned CMC strategies, eCTD content management for IND/IMPD/BLA, FDA Type A/B/C readiness, EVM and sponsor reporting.
Novavax — Senior Program Manager, CMC · May 2023–Sep 2025
Led integrated global CMC execution across Phase 1–3, PPQ, launch readiness, and commercial manufacturing for NVX-CoV2373 and XBB.1.5. Global filings across FDA, EMA, MHRA, Health Canada, TGA, PMDA, WHO PQ, and partner authorities. Tech transfer across FUJIFILM Diosynth, SK Bioscience, Takeda, Serum Institute of India/COVAX, and AGC Biologics.
Novavax — Program Manager, CMC · Apr 2021–May 2023
Supported Phase 1–3 progression, CTM supply coordination, EUA readiness, comparability strategy, and multi-program portfolio control across NVX-CoV2373, NanoFlu, COVID-Influenza combination, and pediatric programs.
Akebia Therapeutics — Associate Project Manager · Jun 2019–Apr 2021
Small-molecule CMC tech transfer, NDA/JNDA Module 3 preparation, CDMO governance, and filing readiness for vadadustat.
AI-enabled CMC tools and projects
CMC Decision Intelligence Platform
Cross-functional AI platform unifying CMC, clinical, regulatory, and commercial inputs into a phase-gated LLM + RAG reasoning engine. Five decision modules: Process & Analytical dev, Manufacturing strategy, Regulatory strategy, Supply chain & CoGS, and Risk & portfolio. Human-in-the-loop governance with SME validation, audit trail, and regulatory defensibility. Outputs decision memos, risk dashboards, and submission packages.
BridgeOS — AI-Native CMC Operating System
Chat-first CMC operating system connecting Mission Control, Evidence workspace, CMC Studio, Submission packager, and Lifecycle change map. Turns public regulatory intelligence and private program evidence into route options, milestone workbacks, cited Module 3 sections, and lifecycle impact analysis. Public-safe preview.
Cited Module 3 Generator
AI-enabled authoring workflow that parses batch records, stability reports, and analytical methods; links evidence to CTD sections; drafts first-pass text with citations; and flags unresolved support gaps before reviewer handoff.
Predictive Risk Engine
Scores schedule stress, dependency exposure, and RAID patterns into intervention themes and escalation paths. Converts risk state into one-page artifacts for governance forums before standard reporting catches up.
Portfolio Control Surface
Consolidates MS Project schedules, Smartsheet trackers, milestone health, and CDMO status into Power BI portfolio dashboards and leadership one-pagers.
CMC Knowledge System
Reusable operating memory for templates, playbooks, lessons learned, and review logic across tech transfer, submission, and lifecycle programs.
CMC Program Dashboard
Audience-specific operating dashboards for leadership (LT view), program management (PM view), and CDMO governance with milestone rollups, KPI snapshots, and action-led review screens.