Pramthesh Patel
BioPharmaceutical R&D executive with 30+ years of experience in Large Pharma and now at a leading CDMO
- Role
- Vice President in Charge of Process Development and Ms & t at Avid Bioservices
- Location
- Lake Forest, CA, US
- LinkedIn followers
- 500 followers
About Pramthesh Patel
Seasoned pharmaceutical leader with a proven track record of driving success in CMC organizations. Demonstrated expertise in spearheading process development for clinical trial material and commercial supplies. Proficient in drafting and reviewing CMC documents for regulatory submissions, contributing to the launch of multiple products. Skilled in technology transfer and project management across global contract manufacturing sites.# Over 30 years of experience in the Pharmaceutical Industryo Demonstrated record of accomplishment in developing manufacturing processes for clinical trial material & commercial supplies.o Experienced in authoring & reviewing CMC documents for regulatory submissions (6 launched products).o Detailed hands-on experience in technology-transfer and managing technical aspects of projects at contract manufacturing sites located around the world.# Strategic Thinker with Tactical Leadership Skillso Leadership role in setting strategic path & growth of Avid Bioservices & GSK’s Bio-Pharmaceutical CMC Division. o Demonstrated ability to lead multi-disciplinary scientific & technical teams. o Proven ability to articulate a long-term vision and set strategic goals with the discipline and focus to implement tactical plans• Technical Expertiseo Technically trained in cellular physiology and molecular biology with experience encompassing Drug Discovery and Development.o Thorough knowledge of various heterologous gene expression technologies and platforms ranging from coli to yeast to mammalian cells.o Experienced in all aspects of drug discovery, including target selection, assay design, HTS/UHTS, lead identification, SAR analysis and lead optimization.o Four issued patents + Over 25 peer reviewed published articles.o Co-author of the A-mAb case study for the application of QbD principles & served on GSK’s committee assisting the advisory board for ICH-11 concept paper. GSK’s sponsor on industry consortia viz. BioPhorum and NIIMBL.
Experience
Vice President in Charge of Process Development and Ms & t
Sep 2022 — Present · Orange County, CA, US
Education
University of Mumbai
Bachelor of Science (B.Sc.), Microbiology, General
1973 — 1977
University of Florida
Ph.D, Microbial & Cellular Physiology
1980
Southern Illinois University
MS, Microbiology
1978 — 1980
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