Principal Scientist, Analytical Development
AlkermesWaltham, Massachusetts, United States • Ireland • Athens, Ohio, United States
Posted October 15, 2025
Full Time
About the Company
Alkermes is a pharmaceutical company specializing in the development of medicines for complex psychiatric and neurological disorders. With a portfolio of proprietary products and a pipeline of clinical candidates, Alkermes leverages its deep neuroscience expertise to address conditions often overlooked or stigmatized. The company's patient-inspired approach, integrated research strategy, and commitment to holistic support for patients and communities distinguish it in the industry.
Job Description
Alkermes is seeking a Principal Scientist within their Analytical Development team to provide technical leadership for small molecule analytical methodologies. The role involves characterizing drug substance, product, impurities, and degradants, ensuring compliance with ICH and FDA guidance, and driving key decision-making for drug development. The company focuses on developing medicines for psychiatric and neurological disorders and is committed to diversity and inclusion.
Requirements
- Serve as the primary Analytical Development representative on CMC teams.
- Provide strategic CDMO oversight for analytical activities.
- Design, execute, and analyze analytical method validation and transfer activities.
- Develop, review, and approve analytical source documents.
- Develop, review, and approve analytical source documents for regulatory submissions.
Benefits
- Competitive salary
- Opportunities for professional development
- Collaborative team environment
