Nathan Robinson-Alden
- Role
- Rhythm Pharmaceuticals Inc.
- Location
- Beverly, MA, US
- LinkedIn followers
- 500 followers
About Nathan Robinson-Alden
Analytical sciences and quality control professional with extensive experience across…
Experience
Present
Skills
- Gmp
- U.s. Food and Drug Administration (Fda)
- Quality Control
- Quality Management
- High-Performance Liquid Chromatography (Hplc)
- Assay Development
- Analytical Chemistry
- U.s. Pharmacopeia (Usp)
- Ich Quality Guidelines
- Abbreviated New Drug Application (Anda)
- New Drug Application (Nda)
- Corrective and Preventive Action (Capa)
- Change Control
- Analytical Method Validation
- Excipients
- Raw Materials
- Stability Programs
- European Pharmacopeia (Ph.eur.)
- Marketing Authorization Application (Maa)
- Oos/Oot
- U.s. Title 21 Cfr Regulation (Parts 11, 210 & 211)
- Investigational New Drug (Ind) Application
- Active Pharmaceutical Ingredient (Api)
- Chemistry, Manufacturing, and Controls (Cmc)
- Process Performance Qualification (Ppq)
- Critical Quality Attributes (Cqa)
- Dissolution/in Vitro Release
- Characterization of Impurities
- Quality by Design (Qbd)
- European Medicines Agency (Ema)
- Anvisa (Agência Nacional De Vigilância Sanitária)
- Contract Manufacturing
- Pai and Gmp Inspections
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