Ashvin Patel
Cmc Consultant @Sotio Biotech
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WORK HISTORY
Cmc Consultant @Sotio Biotech
Supporting clinical development of ADC products
EDUCATION
Abertay University
MSc, Biotechnology
Gujarat Agricultural University
MSc, Veterinary Microbiology and Immunobiology
SKILLS
ABOUT ASHVIN PATEL
Experienced CMC and QA professional with over 20 years’ experience within pharmaceutical and biotechnology industry. A successful track record of achievement and delivery in the following key areas:CMC, QA and regulatory support for clinical development of small, biological, ATMP and siRNA molecules. Sponsor oversight and project management of CMOs.Preparation/writing of CMC (chemistry, manufacturing and control) dossiers and modules for EU (IMPD and MAA) and US (IND and NDA) submission.FDA audit preparation and remediation activitiesPharmaceutical GMP and QA auditsSpecific Attributes: GMP manufacturing, Bioprocessing, Outsourcing management, Technical operations management, Process development and Scale up, Technology Transfer, Process Validation, Viral and Bacterial Vaccines, Quality Control, Quality Assurance and Compliance, Regulatory dossier writing and reviewing.
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