Aswin Sundaram
Biotech Leader | CMC & Tech Ops
- Role
- Vice President, Cmc at Osanni Bio
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Aswin Sundaram
Technical operations leader with an exceptional record of driving disciplined execution, building and managing partnerships, and catalyzing strategic growth at start-ups and global enterprises. Key accomplishments include:• Hands-on product development, NDA authoring, supply chain establishment, and regulatory authority interfacing to enable new product launches across a wide range of technology platforms (e.g. sterile injectables, tablets, capsules, oral solutions, wipes, gels, combination products, etc.) and markets.• Development and implementation of CMC strategies during product Life Cycle Management (LCM) stages to drive COGS reduction, supply chain diversification, and continued market innovation.• Growing and managing technical operations teams (including direct and indirect FTE, contractor, and consultant responsibilities). Creation and integration of Joint Product Teams, and establishment of corresponding governance structures, to facilitate organizational growth and foster collaborative communication channels. • Identification, establishment and management of external vendor, strategic partner, and CDMO relationships at virtual companies.• Budget creation and management for end-to-end technical operations; including, but not limited to: product development, drug substance manufacturing, drug product manufacturing, packaging, analytics, quality assurance, and supply chain & logistics.
Experience
Vice President, Cmc
Mar 2025 — Present · San Francisco, CA, US
Education
Case Western Reserve University
B.S., Biomedical Engineering
Skills
- Data Analysis
- Product Launch
- Pharmaceutics
- Solid Oral Dosage Forms
- Technology Transfer
- R&D
- Lifesciences
- Glp
- Medical Devices
- Quality System
- V&V
- Capa
- Tablet Compression
- Process Simulation
- Iso 13485
- Packaging
- Biomaterials
- Uv/Vis
- Biomedical Engineering
- Lyophilization
- Cell Culture
- Validation
- Research
- Quality by Design
- Campaign Launch
- Filling
- Gmp
- Liquid Sterile Dosage Forms
- Granulation
- Hplc
- Formulation
- Drug Delivery
- Design of Experiments
- Pharmaceutical Industry
- Fda
- Milling
- Api
- Chromatography
- Biotechnology
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