Senior Project Manager, CMC · Sabin Vaccine Institute
Jatin Vaghasiya
AI for regulated pharma. Strategy and program leadership.
I build AI workflows for evidence review, program risk, and portfolio decisions. My work is grounded in CMC strategy and cross-functional program leadership across vaccines, biologics, and small molecules at Sabin Vaccine Institute, Novavax, and Akebia Therapeutics.
Open to mentoring, advising, and collaboration
Programs, partners, and funders that I worked with
More tools. Each one has a working demo.
How these tools stay inside the rules →All 7 tools →Module 3 drafting. A source for each sentence.
Click a sentence to see its source rows. A claim that the data cannot support goes to the reviewer, not into the draft.
- Reads the source documents: batch records, stability reports, and method reports.
- Writes the draft section with a citation on each sentence.
- Shows the reviewer the source rows for each claim.
- Holds back each claim that the data cannot support.
Source
STB-RPT-014 · Drug product stability report
Three commercial-scale batches · long-term storage at 5 °C ± 3 °C · Table 3 shows batch DP-001
| Test | 0 mo | 6 mo | 12 mo |
|---|---|---|---|
| Potency (%)Spec 80 to 125 | 101 | 99 | 98 |
| Purity, SEC (%)Spec ≥ 95.0 | 98.9 | 98.6 | 98.4 |
| AppearanceSpec Clear, colorless | Conforms | Conforms | Conforms |
| pHSpec 6.8 to 7.6 | 7.2 | 7.2 | 7.3 |
Drafted section
Click a sentence to see the source rows that support it.
The draft does not state a 24-month shelf life. The source set has no 18-month or 24-month results. Thus the tool flags the claim and does not write it.
Where I worked. Three companies, from clinical supply to launch.
Full experience →2025 to now
Sabin Vaccine Institute
Senior Project Manager, CMC
CMC and Technical Operations strategy for the Marburg and Sudan ebolavirus vaccines (cAd3), funded by BARDA.
Read more →2021 to 2025
Novavax
Program Manager → Senior Program Manager, CMC
COVID-19 vaccine. The only CMC program manager for all drug substance, drug product, and method transfers across seven manufacturing partners, through PPQ and launch.
Read more →2019 to 2021
Akebia Therapeutics
Associate Project Manager
Vadadustat for anemia in chronic kidney disease. Tech transfer to the drug substance and drug product suppliers. The Module 3 document plan for the US and Japanese NDAs.
Read more →Today in CMC and biotech. In plain words, updated daily.
All news →Do you work on CMC or AI for regulated work?
I am glad to connect with people who move into CMC, regulatory, and program management, and with teams that build AI tools for this work. I also like to discuss tech transfer, PPQ, comparability, or Module 3, and I welcome joint articles and talks about AI in regulated manufacturing.
Send me a LinkedIn message or email me.