Profile Details

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USD 50 /hr

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Hire Dr. Sampath S.

India

USD 50 /hr

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

Profile Summary

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:

Subject Matter Expertise

• ☆ 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

Services

• Writing

Writing Non-Medical Regulatory Writing, Technical Writing, Copywriting

Work Experience

Vice President-Quality

Biofusion Therapeutics

April 2020 - August 2022

Associate Research Director

Syngene International

October 2017 - March 2020

Senior Group Leader

Syngene International

May 2016 - September 2017

Assistant Vice President

Stelis Biopharma

May 2015 - April 2016

Associate Director

Biocon Limited

January 2012 - February 2015

Principle Scientist

Dr Reddy's Laboratories Ltd

October 2007 - December 2011

Staff Scientist

University Health Network, Toronto, Canada

January 2004 - September 2007

Post Doctoral Fellow

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

September 2002 - December 2003

Education

PhD

National Tsing Hue university, Taiwan

June 1997 - September 2001

Certifications

• Executive General Management

  Indian Institute of Management, Bangalore

  January 2013 - Present

• Regulatory Affairs Certification [US]

  Regulatory Affairs Professionals Society

  December 2019 - December 2022