Hanmant Salunkhe
F&D, Technology Transfer
- Role
- Lead F & d at Srs Research Centre
- Location
- Solapur, MH, IN
- LinkedIn followers
- 500 followers
Experience
Lead F & d
Aug 2023 — Present · Navi Mumbai, IN
Formulation & Development (F&D)Design & optimize formulations (tablets, capsules, injectables, etc.) as per USP/Ph. Eur. guidelines.Select excipients, processes, and packaging suitable for US/UK regulatory expectations.Conduct QbD-based development with risk assessments (DoE, CPPs, CQAs).Tech Transfer (TT)Transfer lab-scale / pilot-scale formulation to commercial manufacturing.Review of TT documents (BMR, BPR, MFR, process validation protocols).Train manufacturing teams and resolve scale-up issues.Ensure compliance with cGMP, ICH, FDA, MHRA requirements.Regulatory & Market-Specific FocusSupport ANDA / NDA (US) and MA (UK/EU) filings.Align product specifications with in House / USP, BP, and Ph. Eur. monographs.Provide data for CMC (Module 3 of CTD) submissions.Address regulatory queries (FDA deficiency letters, MHRA Q&A).Cross-Functional LeadershipCoordinate with RA, QA, Manufacturing, Packaging, and Supply Chain.Lead troubleshooting during exhibit/validation batches.Manage timelines to meet first-to-file / launch deadlines.
Education
Shri Santkripa College of Pharmacy, GHOGAON,
Bachelor of Pharmacy - BPharm
2008 — 2012
Gauri Shankar Institute of Pharmasutical Education and Research
Master's degree
2014 — 2016
LSVD JAWALA
Bachelor of Pharmacy - BPharm
2006 — 2008
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