Jatin Vaghasiya

CMC program experience: vaccines and small molecules

I have seven years of CMC program management for vaccines and small molecules, and more than ten years in pharma and biotech. The work goes from first clinical supply through approval, commercial launch, and post-approval change.

10+ years
Pharma and biotech
20+
Regulatory submissions and post-approval changes
Phase 1 → commercial
Lifecycle coverage
2M+ doses
Launch supply across 12 markets

Washington, DC (Remote)

Sabin Vaccine Institute

Senior Project Manager, CMC

Sep 2025 to present
  • Own the integrated CMC and Technical Operations strategy for the Marburg and Sudan cAd3 vaccine programs. Turn Phase 2, Phase 3, and outbreak-response scenarios into the CMC critical path, and frame manufacturing, filing, and supply tradeoffs for leadership.
  • Manage U.S. Government contract work with BARDA: contract milestones, Statements of Work, RFPs, contract modifications, budgets, accruals, and earned value variance reports.
  • Plan CMC submissions for the IND and BLA pathways, with timelines, content strategy, and FDA responses.

Programs

Marburg and Sudan ebolavirus vaccines (cAd3): Adenovirus-vectored vaccine programs. The CMC plan covers Phase 2, Phase 3, and outbreak-response scenarios.

Regulators and pathways

FDA (IND, BLA)

Full scope of the role
  • Work with Program and CMC leadership to turn the development strategy into integrated CMC plans, schedules, budgets, resource needs, and deliverables.
  • Lead the day-to-day management of the drug product process development providers. Coordinate deliverables, timelines, dependencies, and inputs against the CMC strategy and program milestones.
  • Build and manage logic-linked integrated schedules that show the critical path, decision points, assumptions, and schedule risks. Check that each schedule is realistic and matches program commitments.
  • Assess changes in scope, strategy, or assumptions, and show the effect on schedule, cost, resources, risk, and downstream work.
  • Lead CMC regulatory plans and the execution of submissions for the IND and BLA pathways. The scope includes filing timelines, content strategy, response plans, and FDA interactions.
  • Act as the primary contact for CMC project management with BARDA, the U.S. Government funder. Manage contract milestones, deliverables, Statements of Work, budget development, accruals, and variance analysis.
  • Work with Finance, functional leads, and the earned value management (EVM) team on budgets, forecasts, actuals, and variance analysis. Report cost and schedule performance as the U.S. Government contract requires.
  • Support prime contract and subcontract planning with technical staff and Grants and Contracts. Help prepare Statements of Work, RFPs, proposal evaluations, bases of estimate, and contract modifications.
  • Hold internal teams, CDMOs, testing laboratories, and consultants accountable for accurate status, early escalation, and delivery to schedule and budget. Find variances and agree corrective or recovery actions with the accountable leads.
  • Keep project controls current: agendas, minutes, schedules, action and decision logs, risk registers, and milestone reports. Give clear updates to Program leadership, governance bodies, and funders.
  • Manage technical, regulatory, manufacturing, validation, and supply risk early, with risk registers, scenario assessments, and mitigation plans.
  • Coordinate technology transfer, analytical method transfer, scale-up plans, and validation activities across sites.
  • Work with Quality Assurance and Technical Operations on GMP compliance, change control, deviation and CAPA management, and inspection readiness.
  • Improve project management tools and practices, and help build the R&D project management standards.

Gaithersburg, MD (Remote)

Novavax

Senior Program Manager, CMC

May 2023 to Sep 2025
  • Led launch readiness and supply tracking across 12 markets for more than 2 million COVID-19 vaccine doses, with no critical supply disruption.
  • Sole CMC program manager for every drug substance, drug product, and analytical method transfer across a seven-partner network. Had primary accountability for PPQ, validation, and stability.
  • Built CMC dashboards that reduced manual reporting by more than 12 hours a week. My risk models showed milestone risks 4 to 6 weeks earlier.

Programs

NVX-CoV2373: A recombinant vaccine that uses spike protein nanoparticles with Matrix-M adjuvant (XBB.1.5 formulation). The work went from Phase 1/2 CTM through Phase 3 scale-up, EUA supply, COVAX stockpiling, and commercial production. Today, Sanofi sells the vaccine as Nuvaxovid under a 2024 agreement with Novavax.

Regulators and pathways

FDA (BLA, EUA), EMA (IMPD), MHRA, Health Canada, TGA, PMDA, WHO PQ / COVAX PQ, TFDA, IMOH, HSA

Tools built in this role

CMC Portfolio Control, CMC Risk Engine, Module 3 Authoring Tool, CMC Knowledge System

Full scope of the role
  • Led global CMC operations with ICH Q8/Q11 QbD principles across Phase 1 to 3 and commercial programs. This work included CQA/CPP definition and process design space.
  • Was the sole CMC PM for all DS, DP, and analytical method tech transfers between sites and CDMOs. Kept design space integrity through each transfer.
  • Held primary accountability for PPQ execution, process validation, analytical method validation, stability execution, and commercial-scale site qualification.
  • Supported CMC execution for 20+ regulatory submissions and post-authorization changes across FDA, EMA, MHRA, Health Canada, WHO, PMDA, TGA, and partner markets. Maintained 18 to 24 month Content and Document Plans for Module 3 readiness.
  • Managed post-approval variation filings under ICH Q12 PACMPs, and lifecycle regulatory changes, in all jurisdictions.
  • Led Integrated Program Team operations across 12+ disciplines. Developed RACI matrices and RAID logs to support decisions and resolve dependencies. Mentored two junior project managers and three coordinators, and standardized CMC playbooks, templates, and RACI models. Onboarding time went down by 40 to 50 percent.
  • Ran launch operations from business case approval through commercial launch and post-launch stabilization. The scope included COVAX, WHO PQ, Latin America, Europe, Canada, Australia, Japan, Taiwan, Singapore, Israel, South Korea, and New Zealand.
  • Aligned DS/DP schedules, labels and packaging, cold-chain qualification, import/export tests, and volume ramp-up with regional regulatory approvals.
  • Maintained executive RAID dashboards for senior leadership and Board governance. The dashboards tracked regulatory milestones, validation readiness, and portfolio risk posture.
  • Built CMC dashboards that reduced manual reporting by more than 12 hours a week. Built risk models that showed schedule, supply, PPQ, and regulatory risks 4 to 6 weeks earlier.
  • Led launch readiness and supply tracking across 12 markets for more than 2 million doses, with no critical supply disruption.
  • Kept cGMP compliance under the ICH Q10 PQS during high-volume commercial manufacturing. This included change control, deviation impact assessments, CAPA execution, and 21 CFR Part 11 / ALCOA+ data integrity.

Program Manager, CMC

Apr 2021 to May 2023
  • Coordinated the manufacture of Phase 1/2 clinical trial material for the COVID-19 vaccine, in line with IND commitments and BARDA milestones.
  • Supported Phase 3 scale-up at the same time as emergency use preparation for FDA, MHRA, TGA, and Health Canada. Led the move from emergency COVAX supply to commercial stockpiling.
  • Managed comparability studies and Module 3 variations across four parallel vaccine programs.

Programs

NVX-CoV2373: From Phase 1/2 CTM manufacture through Phase 3 scale-up, EUA preparation, and the move from emergency supply to commercial stockpiling.

NanoFlu: A quadrivalent influenza vaccine with recombinant HA. Phase 3 program. Lancet Infectious Diseases published the results in 2021.

COVID-Influenza Combination: Phase 1/2 in Australia, September 2021.

Hummingbird: A pediatric Phase 2b/3 program.

Omicron variant program: A change to the variant strain, with the related comparability work and Module 3 variations.

Regulators and pathways

FDA (EUA), MHRA, TGA, Health Canada, WHO PQ

Full scope of the role
  • Set up PM frameworks (RAID log, RACI matrix, and decision log) for cross-functional accountability across CMC, Regulatory, Manufacturing, and Supply Chain.
  • Coordinated the manufacture of Phase 1/2 Clinical Trial Material for NVX-CoV2373. Aligned DS/DP batch schedules, QC release, cold-chain logistics, and import/export to IND commitments and BARDA milestones.
  • Led QbD tech transfers aligned to ICH Q11, and kept design space and CQA/CPP continuity.
  • Supported Phase 3 manufacturing scale-up at the same time as EUA preparation for FDA, MHRA, TGA, and Health Canada.
  • Coordinated Module 3 CMC content, batch data, stability packages, and responses to health authority queries on emergency timelines.
  • Managed COVAX AMC supply through manufacturing partners, in line with WHO PQ and UNICEF schedules. Led the transition from EUA emergency supply to commercial stockpiling.
  • Managed multi-project CMC portfolios with scenario plans, what-if analysis, and resource forecasts. Moved programs through stage-gate transitions from Phase 1 to commercial readiness.
  • Managed DS/DP comparability studies and Module 3 variation filings across the NanoFlu, combination, pediatric, and variant programs.

Cambridge, MA

Akebia Therapeutics

Associate Project Manager, CMC Regulatory Affairs

Jun 2019 to Apr 2021
  • Supported tech transfer of processes and analytical methods for vadadustat to its drug substance and drug product CDMOs.
  • Kept the Module 3 Content and Document Plan for the US and Japanese NDA submissions. The plan tracked draft status, versions, and gap closure.
  • Built RACI and RAID governance, and maintained CMC timelines, Statements of Work, and budgets.

Programs

Vadadustat: An oral small-molecule HIF-PH inhibitor for anemia caused by chronic kidney disease. Submissions: NDA and JNDA. Japan approved it in 2020. The FDA approved it as Vafseo in March 2024.

Regulators and pathways

FDA (NDA), PMDA (JNDA)

Full scope of the role
  • Supported ICH-compliant technology transfer of processes and analytical methods to CDMOs for vadadustat. Helped keep CQA/CPP continuity, GMP compliance, and timeline adherence.
  • Supported the preparation of eCTD-format CMC Module 3 sections for the NDA and JNDA submissions.
  • Maintained the Content and Document Plan. It tracked draft status, version control, and gap closure against regulatory milestones.
  • Developed RACI matrices and maintained RAID logs to define cross-functional ownership. Tracked risks, actions, issues, and decisions across Quality, Regulatory Affairs, Supply Chain, and Finance.
  • Maintained detailed CMC timelines, Statements of Work, and budgets.
  • Standardized PM processes to make execution accountable and to support continuous improvement in transfer and filing workflows.

CDMOs, partners, and funders. One network across three companies.

CDMOs and manufacturing partners · 13 partners

Drug substance, drug product, and vectors.

  • AGC Biologics
  • Catalent
  • ESTEVE CDMO (formerly Esteve Química)
  • FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies)
  • Jubilant HollisterStier
  • Patheon (Thermo Fisher Scientific)
  • Recipharm
  • ReiThera
  • Serum Institute of India
  • Siegfried
  • SK bioscience
  • Takeda
  • WuXi STA

Clinical supply, packaging, and logistics · 3 partners

Labels, kits, storage, and shipping.

  • PCI Pharma Services
  • Sentry BioPharma Services
  • Thermo Fisher Scientific

Government and global health · 3 partners

Funding and global vaccine supply.

  • BARDA
  • COVAX AMC
  • UNICEF

Earlier roles. Where the GMP work started.

Sep 2018 to Jun 2019

Akebia Therapeutics

Temperature Excursion Management Specialist (Contract, Redbock LLC)

Assessed cold-chain excursions and supported their disposition in clinical supply distribution.

Jun 2013 to Apr 2016

Lorance Pharma

Quality Assurance Specialist / QC Technician

Did GMP quality assurance and QC tests on the manufacturing floor. My documentation discipline started here.

Education. Clinical trials project management and pharmacy.

2016 to 2018

Master of Science, Project Management (Clinical Trials)

Northeastern University, Boston, MA

2009 to 2013

Bachelor of Pharmacy

Gujarat Technological University, India

Do you want the details behind this work?

I can explain any of these programs: the partners, the filings, and what went wrong.

Email me