Essential Duties and Responsibilities*
- Provides in depth technical and scientific advice and guidance to contract service providers and analysts in the Quality Control Operations. This advice includes external laboratory guidance investigations and protocol deviations.
- Lead review of stability analyses and investigations on drug substance and drug product for various techniques (HPLC, Dissolution, Titration, CE, etc.) according to protocol, specifications, analytical methods and procedures.
- Develop, establish and implement quality control processes, specifications, validation, reports, etc. both internally and externally to
- support Esperion's commercial programs.
- Ensure testing and release services are provided in support of established schedules by being the primary technical and project management liaison with counterparts at the CMOs and contract laboratories.
- Work directly with and provide technical support to operating entities