Sr Scientist - Analytical Development
About the Role
The Sr. Scientist, Analytical Development is responsible for leading analytical activities supporting clinical-stage drug substance and drug product development programs. This role provides phase-appropriate analytical development, validation, and analytical CMC regulatory support to ensure successful advancement of development candidates through clinical and commercial milestones. The Sr. Scientist will lead analytical method development and validation activities, analytical risk assessments, and control strategy development for drug substance, drug product, excipients, impurities, degradation products, and critical quality attributes. The individual will serve as a key technical contributor and cross-functional partner while providing scientific oversight of external laboratories and development organizations.
Key Responsibilities
- Develop and execute analytical development plans aligned with CMC milestones, clinical timelines, regulatory requirements, and overall product development strategy
- Design, develop, optimize, qualify, validate, and transfer analytical methods for drug substance, drug product, raw materials, in-process controls, and stability testing in accordance with ICH, FDA, USP, and cGMP requirements.
- Lead analytical risk assessments and contribute to development of phase
