
Santosh Bhende
- Highly motivated Drug Product formulator and regulatory professional with 12 years of experience in Formulation Development of... | Pune, Maharashtra, India
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Santosh Bhende’s Emails sa****@la****.com
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Santosh Bhende’s Location Pune, Maharashtra, India
Santosh Bhende’s Expertise - Highly motivated Drug Product formulator and regulatory professional with 12 years of experience in Formulation Development of Solid Oral, MUPS, Soft gel and ophthalmics dosage forms for regulated market. - Presently associated with Janssen Pharmaceuticals (J&J) in Material Science. Professional Skills - With a proven ability to develop and apply new technologies independently, I am able to work on multiple projects simultaneously. - I have demonstrated an ability to provide scientific inputs and make decisions to resolve problems. - I am also able to maintain a high level of scientific expertise in the field of excipients and it's characterization technique to be applied in the Drug product development and Regulatory space. Job Responsibilities Presently, my job responsibilities in Material Science include the preparation and review of regulatory documents such as Drug product Nitrosamine risk assessment, GMP risk assessment of excipients, Technical material qualification reports, - Pharmacopeial equivalence documents, excipient compatibility reports, safety reports, analytical method equivalency reports, Technically unavoidable particle profile (TUPP) of excipients - Extractable and leachable assessments of polymeric contact materials to ophthalmic and injectable products. - Responsible for presentation of departmental dashboards, regulatory monitoring, CMC, and coordination of material characterization activities with contract labs. - Responsible for preparing sound scientific responses to queries from different regulatory agencies. Achievements - In terms of formulation development, I have successfully completed filing of several products, including complex generic ANDAs. - I was actively involved in the commercial scale plant readiness and execution of validation batches for solid oral formulations. - Additionally, I was involved in the equipment installation and commercial scale plant readiness for a soft gel formulation facility. With my experience in the formulation development and regulatory space, my ability to develop and apply new technologies independently, I would be an asset to any organization. My achievements in formulation development demonstrate my ability to execute projects successfully, and my professional skills make me an effective communicator and collaborator.
Santosh Bhende’s Current Industry Labcorp Drug Development
Santosh
Bhende’s Prior Industry
Abbott
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Lupin
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Sun Pharma
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Intas Pharmaceuticals
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Teva Pharmaceuticals
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Labcorp Drug Development
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Work Experience

Labcorp Drug Development
Associate Manager
Tue Feb 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Teva Pharmaceuticals
Formulation Researcher
Sun Aug 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Feb 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Intas Pharmaceuticals
Research Scientist
Thu Mar 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Aug 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Sun Pharma
Senior Executive
Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Mar 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Lupin
Research Associate
Sun Jul 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott
Research Intern
Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jul 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)