Rohit Thamke
Product specialist at Intas | Healthcare, biosimilars, medical devices | Ex-BBL |
- Role
- Associate Scientist at Intas Pharmaceuticals
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Rohit Thamke
Healthcare product development specialist with 9 years experience across diverse…
Experience
Associate Scientist
Aug 2024 — Present
Biosimilars CMC & combination product development: Generated primary data for biosimilar & HC mAb for BLA, EMA CMC as per ICH Q8. R&D Documentation: Study protocols, technical reports, Autoinjector development, Medical harm checklist, Query response, CMC section review 3.2.P for EMA filling. GMP documentation: Design History File (Combination product-Device), DP TTD, change control, process validation report, CPV protocol, FMEA, Quality risk management- Mfg. process & secondary, tertiary packaging, VHP sterilization, NBOP-BSI: Design, Use related risk-medical harm, DP mfg. process, packaging for EMA filling, Risk management report ICH Q8, Q9, ISO 13485 & ISO 14971.
Education
Savitribai Phule Pune University
M.Pharm
2014 — 2016
Solapur University
B.Pharm
2010 — 2014
Skills
- Polymer Formulation
- Research
- Solid Oral Dosage Forms
- High-Performance Liquid Chromatography (Hplc)
- Peptide Formulation
- Biosimilars
- Ndds
- Formulation
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