James Skrine
- Role
- Amgen
- Location
- Longmont, CO, US
- LinkedIn followers
- 500 followers
Experience
Present
Skills
- Protein Chemistry
- Capa
- Microbiology
- U.s. Food and Drug Administration (Fda)
- Manufacturing
- Compliance
- Quality Auditing
- Process Validation
- Drug Discovery
- 21 Cfr Part 11
- Drug Development
- Change Control
- Biopharmaceuticals
- Regulatory Affairs
- Lifesciences
- Purification
- Quality System
- Quality Systems
- V&V
- Cell Culture
- Process Simulation
- Quality Management
- Technical Writing
- Life Sciences
- Sds-Page
- Corrective and Preventive Action (Capa)
- Ind
- Fermentation
- Biotechnology
- Protein Purification
- Cgmp
- Process Development
- Chromatography
- Commercialization
- Sop
- Fda
- Cross-Functional Team Leadership
- Operational Excellence
- Regulatory Submissions
- Hplc
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