Subrata Das
Senior Director, Chemistry, Manufacturing, and Controls. Head of Drug Product Development at PYC Therapeutics
- Role
- Senior Director, Chemistry, Manufacturing, and Controls Head of Drug Product Development at Pyc Therapeutics Asx Pyc
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Subrata Das
Expertise in generic and brand product development of Ophthalmic, Metered dose inhaler (pMDI), Dry Powder Inhaler (DPI), Nebulizer, Nasal, and sublingual dosage formulations.
Experience
Senior Director, Chemistry, Manufacturing, and Controls Head of Drug Product Development
May 2021 — Present · Los Angeles, CA, US
Lead pre-formulation and formulation development efforts Lead the process development, manufacture, release and stability-related activities during drug product development Lead and manage analytical, specification setting, stability studies for drug product Manage drug candidate supply chain Contribute to program strategy, and design and implement drug product development strategy Oversee and manage technical aspects of drug product release for nonclinical, and clinical efforts Design and oversee execution of process development activities in preparation for registration and validation activities
Education
Louisiana State University
Ph.D., Physiology and Biochemistry
1987 — 1992
University of Calcutta
MS, Zoology
Skills
- Technology Transfer
- Chromatography
- Anda
- Hplc
- Drug Delivery
- Lims
- Validation
- Drug Development
- Pharmaceutical Industry
- Sop
- Fda
- R&D
- Glp
- Standard Operating Procedure (Sop)
- Regulatory Submissions
- Ind
- Abbreviated New Drug Application (Anda)
- Dissolution
- Good Laboratory Practice (Glp)
- Analytical Chemistry
- Pharmaceutics
- U.s. Food and Drug Administration (Fda)
- Biotechnology
- Formulation
- Gmp
- CRO
- Regulatory Affairs
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