Shailesh Biradar
Section Head (Associate Research Director) @Syngene International Limited
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WORK HISTORY
Section Head (Associate Research Director) @Syngene International Limited
Bengaluru, IN
Pharmaceutical drug product development for potential global branded pharmaceutical companies (as a client) for:a) Human Health Drug Productsb) Animal Health Drug Products2. Driving CMC section for the drug products (IND package & NDA package), based on:a) Small synthetic moleculesb) Large molecules (Peptides, proteins, and oligonucleotides)c) Biologics (monoclonal antibodies, mAbs & antibody-drug conjugates, ADCs)3. Leading formulation development activities, right from ideation to cGMP scale commercial supply for:a) Oral Drug Productsb) Parenteral Drug Products (injectables, nasal & ophthalmic)4. Authoring the DP project proposals for the branded & generic drug products for conventional drug products and differentiated drug products 5. An active member of the team responsible for driving OU/Dept specifica) Annual operating plan (AOP)b) Business continuity plan (BCP)c) Annual Budget planningd) Innovation program (IP)6. Collaborated with multiple clients, spread globally for DP business opportunities in drug product development and cGMP scale fill-finish (IFF) activities.CRO & CDMO - Business development - US, Europe & Asia
EDUCATION
Bharati Vidyapeeth
Master of Pharmacy
Symbiosis International University
PG Diploma in Intellectual Property Rights
Bharati Vidyapeeth
Doctor of Philosophy (Ph.D.: Pharmaceutics)
Government College of Pharmacy, Aurangabad
B. PHARMACY
ABOUT SHAILESH BIRADAR
Worked with both branded (Ferring & …
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