2016 to 2018
Master of Science, Project Management (Clinical Trials)
Northeastern University, Boston, MA
About Jatin Vaghasiya
I am Jatin Vaghasiya. I build AI tools for regulated pharma work, and I bring more than 10 years of pharma and biotech experience to program leadership. My background spans GMP quality and manufacturing work and small-molecule CMC at Akebia. It also spans vaccine CMC at Novavax and my current role at Sabin Vaccine Institute.
How I work
I work where technical execution meets program decisions. Which evidence is needed? Which dependencies matter? Who owns the next action, and how does the work support a filing or supply milestone? I build AI workflows to make that work easier to review, with source traceability and human judgement at the center.
The tools came from my programs. Evidence was in many different systems, risks became visible too late, and teams learned the same lessons again on each program. Each tool starts from one of those problems, and a person makes each decision.
Tools I use. For programs, and for the AI tools I build.
For programs
Plans, risks, and reports.
- MS Project
- Smartsheet
- Power BI
- Veeva Vault
- SharePoint
- Jira
- Planisware
- Tableau
- Excel
To build tools
Source-linked AI workflows.
- Python
- SQL
- OpenAI and Codex
- Retrieval-augmented generation (RAG)
- React
- GitHub
Education. Clinical trials project management and pharmacy.
2009 to 2013
Bachelor of Pharmacy
Gujarat Technological University, India
Get in touch. Mentoring, advice, and collaboration.
I can help with
- Mentorship for people who move into CMC, regulatory, or program management roles
- Advice for teams that build AI for CMC or regulatory work, and which parts will pass a review by a regulator
- Discussion of a difficult CMC problem, such as tech transfer, PPQ, comparability, or a Module 3 plan
- Joint articles or talks about AI in regulated manufacturing