Maithili Rairkar
CTO & Head of CMC, Alessa Therapeutics
- Role
- Chief Technology Officer & Head of Cmc at Alessa Therapeutics, Inc
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Maithili Rairkar
Pharmaceutical Development professional skilled in drug, device and combination product development • In-depth knowledge of formulation, process (manufacturing and packaging) and analytical method development spanning liquid and solid dosage forms• A self-starter with strong interpersonal and problem solving skills and 20+ years of experience in pharmaceutical and medical device industry, includes 10+ years of supervisory experience• Built and led teams on internal and external collaborative projects• Excellent understanding of cGMPs, QSR’s, Change Control, Design Control and relevant consensus standards such as ICH, ISO• Proven ability to work in a matrix and outsourced environment - experienced working with several domestic and international CMOs and CROs • Developed CMC regulatory strategy for US (IND, NDA) and EU (MAA) – experienced regulatory submissions (IND, NDA, MAA, PMA) and in face to face meetings with regulatory authorities (FDA and EU states)
Experience
Chief Technology Officer & Head of Cmc
Sep 2023 — Present · San Carlos, CA, US
Education
Maharashtra Institute of Technology
B.E., Polymer Engineering
1993 — 1997
The University of Alabama in Huntsville
Ph.D., Materials Science
1997 — 2002
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