Mahesh Pratapwar
Research|Formulation|RegulatoryAffairs|M.Pharm
- Role
- Assistant Manager (F & d) at Caplin Point Laboratories Ltd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Mahesh Pratapwar
I am with over 10 years of experience in pharmaceutical formulation and development, I…
Experience
Assistant Manager (F & d)
Oct 2023 — Present · Chennai, IN
To lead the team members of Pharmaceutical formulation and development department. To deal with cross functional teams, Project managers, CDMOs to meet organizational goals. To initiate new drug product development of Oral Solid, Liquids, Topical Semisolids dosage forms formula optimization and stretch upto commercialization. To perform literature survey and Patent search during development stage. To execute R&D trial batches, Pilot batches, Production commercial batches. To find Product CQAs, CPPs, CMAs, during development and control all attributes to mentain product lifecycle. To prepare documents required for test license and manufacturing license and import license. To prepare MFR, Product Specifications, PDR. To select and procure Excipient and APIs for product development. To provide training to juniors and monitor, assist them in execution of successful experiments. To prepare and review Product development report, Process validation protocol, stability protocol, hold time study protocol. To perform Stability study evaluation.
Education
Dr.D.Y. Patil Institute Of Pharmacy
Master of Pharmacy
2016 — 2017
Government college of Pharmacy, Aurangabad
Bachelor of Pharmacy - BPharm
2012 — 2015
Skills
- Mhra
- Pharmaceutics
- Life Sciences
- Fda Gmp
- Standard Operating Procedure (Sop)
- Freez Dryer
- Good Laboratory Practice (Glp)
- Uv/Vis Spectroscopy
- Production
- Dissolution Testing
- Dra
- Deep Freeze
- Good Documentation Practices
- High-Performance Liquid Chromatography (Hplc)
- World Health Organization
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