Analytical Science and Technology Senior Scientist

Senior Scientist, Analytical Sciences & Technology (AS&T)

General Summary:
Provide analytical-science expertise to support launch readiness and lifecycle management for the commercial small molecule portfolio.

Key Duties And Responsibilities:
- Lead and ensure success of commercial analytical activities: prioritization and execution to meet program commitments
- Serve as SME to ensure analytical method robustness, commercial testing requirements, and analytical event investigations
- Author and/or review technical documents (methods, study protocols, technical reports)
- Partner internally and externally for commercial analytical technology transfer
- Own analytical method validations, continuous improvement, and lifecycle management
- Collaborate with cross-functional teams (Analytical Development, Process Development, Commercial Manufacturing, Supply Chain, Quality, Vertex Partners, and contract test labs)
- Oversee analytical testing and method performance executed at CDMOs and contract testing labs

Knowledge And Skills (Qualifications/Requirements):
- Expertise in analytical method development, characterization, and qualification/validation
- Knowledge of ICH/FDA/EMA guidelines; strong GMP background (small molecule preferred)
- Desirable: experience managing contract (CMO/CDMO) analytical testing
- Experience supporting commercial small molecule products and cGMP manufacturing
- Ability to prioritize across projects and meet timelines while staying flexible
- Excellent technical writing and communication skills
- Hands-on experience with small-molecule methods; dissolution test preferred

Education And Experience:
- BS or higher in Science or related discipline
- 8+ years in pharmaceutical/biopharmaceutical industry (or equivalent combination of education and experience)