Senior Scientist, Analytical Chemistry, Concert Pharmaceuticals, Inc, Lexington, MA: will ensure that scientific data is of high quality from a technical, accuracy, and GMP compliance perspective. This includes overseeing analytical data generated as part of process characterization, method validation, stability studies and regulatory filings. The role involves collaboration with Concert’s Process Chemistry, Formulation and Quality Assurance groups as well as with our partner contract manufacturing organizations (CMOs) to ensure the accuracy of scientific data. Responsibility is undertaken for the tracking and trending of development and commercial batch data, including yearly product reviews. Overseeing stability programs to support clinical development and commercialization and performing the review and/or approval of product specification changes will be undertaken. Support will be provided for investigations?and acting as analytical Subject Matter Expert for CMO audits. The role includes summarizing data and scientific findings in presentations and reports. Contributions will include input to Concert CMC regulatory filings?and any ongoing analytical Quality Risk Management.
Minimum Requirements: Master’s degree in Pharmacy, Pharmaceutical Sciences, Pharmacology, or a closely related field and 3 years’ experience in analytical method development for pharmaceutical formulations. Special Requirements: Must have demonstrated knowledge of: 1) analytical instrumentation including HPLC and GC and 2) Drug substance and drug product analysis. Qualified applicants email resumes to Nikki Cachelin, Senior Human Resources Representative, Concert Pharmaceuticals, Inc at firstname.lastname@example.org with reference to Job Code: SSCP23.