Personal Information
Entreprise/Lieu de travail
San Francisco Bay Area United States
Profession
Analytical Development and Quality Control / Biologics / Group Manager / Bayer
Secteur d’activité
Medical / Health Care / Pharmaceuticals
À propos
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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presentation
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Présentations
(3)J’aime
(56)Components of a typical fermenter
Asmita Sagar
•
il y a 7 ans
Biomarker Strategies
Tom Plasterer
•
il y a 14 ans
Clinical trials: Terminology
Pradeep H
•
il y a 12 ans
Clinical trial design
Sandhya Talla
•
il y a 7 ans
Key Concepts of Clinical Research & Clinical Trial
SWAROOP KUMAR K
•
il y a 8 ans
Clinical Trial Requirements U.S. vs. EU Similarities and Differences
RETIRE
•
il y a 14 ans
Clinical Trial Phases
Dr. Ashutosh Tiwari
•
il y a 9 ans
Clinical trial design
Dr. Ritu Budania
•
il y a 10 ans
Bioanalytical method validation guidelines for ligand binding assays
SHANE_LOBO145
•
il y a 7 ans
USFDA guidelines for bioanalytical method validation
bhatiaji123
•
il y a 5 ans
Sterility assurance
Tim Sandle, Ph.D.
•
il y a 9 ans
The selection and use of reference materials
Tim Sandle, Ph.D.
•
il y a 5 ans
Developments in regulatory requirements
Tim Sandle, Ph.D.
•
il y a 9 ans
Depyrogenation by dry heat
Tim Sandle, Ph.D.
•
il y a 7 ans
Application of microbiological data
Tim Sandle, Ph.D.
•
il y a 8 ans
USP <1116> and its impact on Microbiology
Tim Sandle, Ph.D.
•
il y a 8 ans
Myths of pharmaceutical microbiology
Tim Sandle, Ph.D.
•
il y a 8 ans
Pharmaceutical Microbiology: Current and Future Challenges
Tim Sandle, Ph.D.
•
il y a 5 ans
EU GMP Annex1 Review
Tim Sandle, Ph.D.
•
il y a 7 ans
Risk analysis in sterile operation
Tim Sandle, Ph.D.
•
il y a 9 ans
Cleanroom sop slides
Tim Sandle, Ph.D.
•
il y a 8 ans
ISO 14644 - introducing the revised standard
Tim Sandle, Ph.D.
•
il y a 8 ans
Alert Action and Specification Limits for Bioburden and Endotoxin - SK26Feb15 (3) - Final for PDA Annual Meeting 2015
Stephan O. Krause, PhD
•
il y a 8 ans
As process development and manufacturing (cmc) for biologics development-an overview 26 nov09
Steven S. Lee
•
il y a 14 ans
MABs Stability – Analytical Techniques
Pharmaxo
•
il y a 11 ans
FDA container closure system & drug stability saurav anand 23 iip
hncsaurav
•
il y a 11 ans
The Chemistry of Monoclonal Antibodies
Pharmaxo
•
il y a 11 ans
stability tests for pharmaceutical products
alaaalfayez
•
il y a 11 ans
Stability (Sanjay Dwivedi)
Sanjay180370
•
il y a 9 ans
Personal Information
Entreprise/Lieu de travail
San Francisco Bay Area United States
Profession
Analytical Development and Quality Control / Biologics / Group Manager / Bayer
Secteur d’activité
Medical / Health Care / Pharmaceuticals
À propos
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...
Mots-clés
presentation
Tout plus