プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

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☆☆☆☆☆

Dr. Sampath S.に依頼

India

Biologics development, Quality Assurance, Quality Control, Analytical Development, Validation, CMC, Technical review

プロフィール概要

Pharma Professional with over 20 years of experience, more than 15 years of which have been in Technical & Operational leadership roles. Led the team for the Development, Qualification and Validation of analytical methods to assess and certify product quality and stability. Strategised Technology Transfer [both Analytical Method and Process Transfer] and preparing CMC documents and reviewing CMC documents for medicinal product regulatory submission. Quality & Regulatory Systems and Processes: Guided the team on establishing Pharmaceutical Quality System and product development, program management and to meet regulatory requirements. Provided technical leadership ensuring scientifically sound deviation investigations and corrective and preventive action [CAPA] identification & implementation. Quality Risk Management. Technical input to close deviations and Biopharmaceutical Manufacturing:

専門分野

• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Structural Biology
• ☆ Binding Assays
• ☆ Molecular Biology
• ☆ Protein Sequencing
• ☆ Monoclonal Antibody Production
• ☆ Biophysics
• ☆ Biotechnology & Bioengineering
• ☆ Recombinant Protein Expression
• ☆ Synthetic Biology
• ☆ Human Behavior & Psychology
• ☆ Cognitive Science
• ☆ Organizational Studies
• ☆ Educational Administration
• ☆ Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Drug Stability Testing
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmaceutical Manufacturing
• ☆ Bioprocess Development
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Technology Scouting
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Skills Training
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Grant Writing
• ☆ Formulation
• ☆ Pharmaceutical Formulation
• ☆ Project Management
• ☆ Risk Management
• ☆ Management Consulting

サービス

• Writing

Writing Non-Medical Regulatory Writing, Technical Writing, Copywriting

職務経験

Vice President-Quality

Biofusion Therapeutics

4月 2020 - 8月 2022

Associate Research Director

Syngene International

10月 2017 - 3月 2020

Senior Group Leader

Syngene International

5月 2016 - 9月 2017

Assistant Vice President

Stelis Biopharma

5月 2015 - 4月 2016

Associate Director

Biocon Limited

1月 2012 - 2月 2015

Principle Scientist

Dr Reddy's Laboratories Ltd

10月 2007 - 12月 2011

Staff Scientist

University Health Network, Toronto, Canada

1月 2004 - 9月 2007

Post Doctoral Fellow

National Institutes of Health (NIH, Hamilton, MT, USA)

9月 2002 - 12月 2003

学歴

PhD

National Tsing Hue university, Taiwan

6月 1997 - 9月 2001

認定資格

• Executive General Management

  Indian Institute of Management, Bangalore

  1月 2013 - 現在

• Regulatory Affairs Certification [US]

  Regulatory Affairs Professionals Society

  12月 2019 - 12月 2022