Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Analytical Development and Quality Control / Biologics / Group Manager / Bayer
Industry
Medical / Health Care / Pharmaceuticals
About
Group manager with 15 years’ post-graduate biological research and development experience, including 10 years in CMC Analytical Development (AD) and clinical product Quality Control (QC).
Recently started a new leadership role in commercial product QC organization.
Technical skills in GMP release assay development, validation, comparability and transfer, as well as product extended characterization, GMP testing, CMC regulatory filing, etc.
Extensive project management and people management experience.
Specialized in separation science and physicochemical analysis. Broad experience in other areas of ADQC.
Experience with recombinant proteins, monoclonal antibodies, protein-polymer...
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Presentations
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(56)Components of a typical fermenter
Asmita Sagar
•
7 years ago
Biomarker Strategies
Tom Plasterer
•
14 years ago
Clinical trials: Terminology
Pradeep H
•
12 years ago
Clinical trial design
Sandhya Talla
•
7 years ago
Key Concepts of Clinical Research & Clinical Trial
SWAROOP KUMAR K
•
8 years ago
Clinical Trial Requirements U.S. vs. EU Similarities and Differences
RETIRE
•
14 years ago
Clinical Trial Phases
Dr. Ashutosh Tiwari
•
9 years ago
Clinical trial design
Dr. Ritu Budania
•
10 years ago
Bioanalytical method validation guidelines for ligand binding assays
SHANE_LOBO145
•
7 years ago
USFDA guidelines for bioanalytical method validation
bhatiaji123
•
5 years ago
Sterility assurance
Tim Sandle, Ph.D.
•
9 years ago
The selection and use of reference materials
Tim Sandle, Ph.D.
•
5 years ago
Developments in regulatory requirements
Tim Sandle, Ph.D.
•
9 years ago
Depyrogenation by dry heat
Tim Sandle, Ph.D.
•
7 years ago
Application of microbiological data
Tim Sandle, Ph.D.
•
8 years ago
USP <1116> and its impact on Microbiology
Tim Sandle, Ph.D.
•
8 years ago
Myths of pharmaceutical microbiology
Tim Sandle, Ph.D.
•
8 years ago
Pharmaceutical Microbiology: Current and Future Challenges
Tim Sandle, Ph.D.
•
5 years ago
EU GMP Annex1 Review
Tim Sandle, Ph.D.
•
7 years ago
Risk analysis in sterile operation
Tim Sandle, Ph.D.
•
9 years ago
Cleanroom sop slides
Tim Sandle, Ph.D.
•
8 years ago
ISO 14644 - introducing the revised standard
Tim Sandle, Ph.D.
•
8 years ago
Alert Action and Specification Limits for Bioburden and Endotoxin - SK26Feb15 (3) - Final for PDA Annual Meeting 2015
Stephan O. Krause, PhD
•
9 years ago
As process development and manufacturing (cmc) for biologics development-an overview 26 nov09
Steven S. Lee
•
14 years ago
MABs Stability – Analytical Techniques
Pharmaxo
•
11 years ago
FDA container closure system & drug stability saurav anand 23 iip
hncsaurav
•
11 years ago
The Chemistry of Monoclonal Antibodies
Pharmaxo
•
11 years ago
stability tests for pharmaceutical products
alaaalfayez
•
11 years ago
Stability (Sanjay Dwivedi)
Sanjay180370
•
9 years ago
Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Analytical Development and Quality Control / Biologics / Group Manager / Bayer
Industry
Medical / Health Care / Pharmaceuticals
About
Group manager with 15 years’ post-graduate biological research and development experience, including 10 years in CMC Analytical Development (AD) and clinical product Quality Control (QC).
Recently started a new leadership role in commercial product QC organization.
Technical skills in GMP release assay development, validation, comparability and transfer, as well as product extended characterization, GMP testing, CMC regulatory filing, etc.
Extensive project management and people management experience.
Specialized in separation science and physicochemical analysis. Broad experience in other areas of ADQC.
Experience with recombinant proteins, monoclonal antibodies, protein-polymer...
Tags
presentation
See more