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Senior Analytical Chemist.

Employer
Vanda Pharmaceuticals
Location
Washington, DC
Closing date
Nov 12, 2019

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Industry
Science
Function
Accountant, IT
Hours
Full Time
Career Level
Experienced (Non-Manager)
Senior Scientist, Analytical Chemistry. Position Description & Responsibilities. The senior scientist will be responsible for coordination of drug substance and drug product analytical methods development and validation, development and characterization of reference standards, identification of impurities, management of stability studies, and preparation of analytical chemistry sections of regulatory submissions. Key areas of responsibility include:. . Generation and/or review of analytical methods and stability study protocols and reports. . Troubleshooting issues related to analytical methods/data. . Management of analytical chemistry activities at third-party CMOs. . Management of synthesis and characterization of reference standards for APIs and impurities. . Preparation of analytical chemistry and stability related CMC sections of INDs, IMPDs and NDAs. Position Requirements. . Successful candidates will have the following background/experience:. . Ph.D. in analytical chemistry with 2-4 years of experience or MS in analytical chemistry with 7-10 years of experience. . Thorough knowledge and understanding of analytical chemistry methodologies commonly used for characterization of small molecule drug substances and drug products. . Familiarity with ICH, FDA, and USP guidance documents relating to drug substance and product analysis and quality control. . Excellent written and oral communication skills. . Ability to work independently on projects. . Ability to work effectively and efficiently on multiple projects.

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