Bernard Shamsai
- Role
- Executive Director, Process Development at Gilead Sciences
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Bernard Shamsai
Seasoned pharmaceutical executive, 20+ years of technical and managerial experience in…
Experience
Executive Director, Process Development
Dec 2018 — Present
Leadership in CMC, commissioning and qualification, engineering, automation, and technology transfers to CMOs. Expertise in complex injectable products, including liposomes, suspensions, long-acting release formulations and biologics. Operational leadership in sterile manufacturing organizations and facilities.
Education
UCLA
PhD, Chemical Engineering
1992 — 1997
University of Southern California
BS, Chemistry, Chemical Engineering
1989 — 1992
Skills
- Valuation Modeling
- Capa
- Drug Product
- Due Diligence
- Start-Up Consulting
- Regulatory Affairs
- Process Simulation
- Biotechnology
- Drug Development
- Technology Transfer
- Operations Management
- 21 Cfr Part 11
- Process Control
- Drug Testing
- Controlled Release
- Pharmaceutical Manufacturing
- Business Analysis
- Manufacturing Operations Management
- Aseptic Processing
- Project Management
- Downstream Processing
- Product Design
- Global Operations
- Scale-Up
- Biopharmaceuticals
- Contract Negotiation
- Drug Delivery
- Process Engineering
- Pharmaceutical Industry
- Start-Up Ventures
- Analytical Chemistry
- Technical Recruiting
- Business Development
- Analytical Method Validation
- Aseptic Technique
- Venture Capital
- Pharmaceutics
- Biotechnology Industry
- Pharmaceutical Packaging
- Global Regulatory Compliance
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