Girish Pendse
Vice President, Global Head of Protein Therapeutics Api Development at Johnson & Johnson Innovative Medicine
Based in United States
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Seniority
Vp
Department
Science
Location
United States
Industry
Pharmaceutical Manufacturing
Company size
39K
Contact information
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g•••••••@innovativemedicine.jnj.com
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Background
About Girish Pendse
An accomplished leader with 25+ years of diverse experience in Process Development and MS & T roles in the Biopharmaceutical industry including 17 years in management positions. Subject matter expert in biologics drug substance development including cell line development, upstream and downstream process development, process characterization (robustness studies), scale-up and tech transfer as well as cGMP cell banking activities. In depth knowledge of BLA, CTD, FDA, EU and PMDA regulations with proven expertise in providing responses related to drug substance control strategy and cell banking during regulatory inspections/meetings/responses to information requests. Scientific Project Leader with cross-functional oversight leading an interdisciplinary technical team for development, management and execution of overall CMC program strategy for multiple projects. Motivated, flexible, results oriented leader with an excellent interpersonal communication and team building skills, along with a strong aptitude to work with cross-functional teams.
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