Sumit Laxane
Scientist at P&G Consumer Health R and D
- Role
- Scientist at Procter & Gamble
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Sumit Laxane
About 15 years diversified research experience in Preclinical and Clinical Bioanalysis of…
Experience
Scientist
Feb 2016 — Present · Mumbai, IN
Job Profile:• Responsible for sample preparation for method development, method validation and study samples on LC-MS/MS in a GLP environment in support if in vivo and in vitro evaluation of drugs (New Chemical Entity).• Hands on experience in the fields of Analytical and Bioanalytical Development, Quality Systems, Instruments and Quality Control and meet the requirements of Quality assurance and Regulatory affairs.• Review of outsourced analysis data.• Record raw data and processed data as per GLP requirement.• Knowledge and experience with the concepts of quality, analytical and regulatory operations in the Generics and NCE (API and Drug products) field. • Method SOP / protocol and report preparation of the respective projects.• Execute analysis as per GLP and safety procedure requirement in GLP Certified Facility.• Assist section head in executing compliance to observation on Bioanalytical Data by QA and regulatory agencies.
Education
Manipal University
Master of Pharmacy
2006 — 2008
School name:
Bachelor of Pharmacy (B.Pharm.)
2002 — 2006
Skills
- Pharmacokinetics
- Quality Assurance
- Lifesciences
- Pharmacology
- Pharmaceutical Industry
- Hplc
- Glp
- Bioanalysis
- Drug Delivery
- Pharmaceutics
- Drug Discovery
- Life Sciences
- In Vivo
- In Vitro
- V&V
- Method Development
- Lc-Ms
- Chromatography
- Anda
- Medicinal Chemistry
- Regulatory Affairs
- Dissolution
- Sop
- Formulation
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