Nitin Rathore
- Role
- Associate Vice President, Drug Product Process Development at Amgen
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Nitin Rathore
Highly motivated and passionate leader with nearly 20 years of experience in the…
Experience
Associate Vice President, Drug Product Process Development
Aug 2006 — Present
Leadership Experience • Ability to think strategically and drive teams forward effectively in an ambiguous and fast paced environment • Proven ability to lead large teams in advancing Amgen’s entire late stage drug product portfolio comprising of all novel biologics and synthetics assets as well as biosimilar programs • Demonstrated leadership in developing and implementing novel technologies including state-of-the-art Drug Product Formulation development and next generation Drug Product Manufacturing • Operational leadership in building and operationalizing Platforms for delivering Speed, Efficiency and Agility • Experienced in building high performance and diverse team. Run organization of over 100 staff members, manage budgets including capital plan strategy, operational expenses and FTE forecasts • Excellent communication and leadership skills and ability to work efficiently in a matrix environment Process and Product Development Experience • Experienced in leading technical teams responsible for late stage drug product process development and tech transfer to internal and contract manufacturing sites including biologics and synthetics • Experienced in leading process improvement projects for enhancing robustness, speed and economics of new product introductions in clinical and commercial manufacturing • Performance characterization of fill-finish equipment and process steps including filling, stoppering, automated visual inspection system and cleanability of products in support of tech-transfer to multi-product facility • Application of Predictive modeling for various drug product development and manufacturing use cases • Technical leadership in building CMC strategies including regulatory INDa filings, Briefing Books and Marketing Applications
Skills
- Cleaning Validation
- Process Simulation
- Filtration
- Purification
- Formulation
- Chemical Engineering
- Commercialization
- Biotechnology
- Aseptic Processing
- Sop
- Characterization
- Protein Chemistry
- V&V
- Technology Transfer
- Change Control
- Lyophilization
- Product Development
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