PARVEZ SHAIKH
Mumbai
Summary
An innovative formulation research and development professional with
13 years 6 months experience in formulation design and development of solid oral dosage forms for regulated markets (USA and Europe markets) which includes development and technology transfer of modified release dosage forms such as pellets and osmotic drug delivery.
Overview
14
14
years of professional experience
Work History
Research Officer
Flamingo Pharma, Mumbai
Mumbai
02.2014 - 11.2015
- Design and conduct pre-formulation, formulation, process, stability, and container closure development studies for drug products
- Apply scientific fundamentals to solve formulation, stability and manufacturing issues
- Development and technology transfer immediate release tablets and capsules for Europe and ROW markets.
- Prepare professional technical reports, presentations, and documents for regulatory submissions.
Research Executive (Formulation and Development)
USV Limited, Mumbai
Mumbai
11.2010 - 02.2014
- Self-prioritize project work to optimize productivity.
- Literature search, Patent search, FOI searches of allocated projects and interpretation of patent claims.
- Enabling the delivery of the technical aspects of product development of various solid oral dosage forms such as tablets (immediate release, bilayer and matrix release extended release tablets).
- Formulation development activities using Quality by design (QBD) approaches and implementation of Design of Expert (DOE).
- Technology transfer and manufacture of scale up and exhibit batches.
- Compiling relevant documents such as product development report (PDR), Pharmaceutical Equivalency Report (PER), Quality overall summary (QOS) to the agreed timelines.
Deputy Manager (Formulation and Developmen)
Alkem Laboratories Ltd., Mumbai
Mumbai
02.2014 - Current
- Apply scientific fundamentals to solve formulation, stability and manufacturing issues.
- Makes decisions affecting project directions and maintains project timelines.
- Experienced in the development of Solid orals (Tablets & Capsules - modified release, immediate release and oral solutions).
- Formulation development on Pellet formulations of delayed release and extended release products using labscale and production scale wursters (Bottom Spray) for regulated markets.
- Development and technology transfer of Osmotic drug delivery system.
- Successfully developed bioequivalent and got approvals for pellet formulations of Delayed Release and extended release Capsules for USA and Europe markets.
- Product development with QBD approach and DOE (Design of experiments) analysis.
Education
Master of Science - Pharmaceutics
Allana College of Pharmacy, Pune
Pune06.2008
Bachelor of Science - Pharmacy
P.D.V.V.P.F S ,College Of Pharmacy, Ahmednagar
Ahmednagar06.2005
Skills
- Complete projects as assigned and obtain high quality results
- Experience with development and technology transfer for pharmaceutical manufacturing of complex products such as pellets and osmotic drug delivery
- Good communication skills, strong interpersonal skills, and the ability to thrive in an interdisciplinary fast-paced environment
- Demonstrated leadership skills and experience leading a diverse team
- Excellent verbal and written communication and data-analysis skills, including the ability to write technical reports
Accomplishments
- Successfully developed F2F (First to file) project for USA market.
- Successfully developed a bioequivalent and got approved for pellet formulation of Delayed release and extended release capsules for USA and Europe markets.
Timeline
Research Officer
Flamingo Pharma, Mumbai
02.2014 - 11.2015
Deputy Manager (Formulation and Developmen)
Alkem Laboratories Ltd., Mumbai
02.2014 - Current
Research Executive (Formulation and Development)
USV Limited, Mumbai
11.2010 - 02.2014
Master of Science - Pharmaceutics
Allana College of Pharmacy, Pune
Bachelor of Science - Pharmacy
P.D.V.V.P.F S ,College Of Pharmacy, Ahmednagar
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