Found Description
Role Overview
Scientist Stability is responsible for product stability strategy and oversight of stability programs for commercial small‑molecule Drug Substances and Drug Products, including drafting protocols, approving stability reports, and regulatory filings.
Responsibilities
- Accountable for the stability program on assigned brand(s) and acts as Stability Product Lead.
- Participate on transfer teams for new products to internal and external sites, review registrational stability studies, and conduct gap analysis against Global Manufacturing & Supply requirements.
- Develop stability data to fill identified gaps.
- Maintain expertise on overall stability performance of products in the global supply chain.
- Serve as stability representative on project teams covering post‑approval changes, designing and executing required pre‑market stability programs, performing change‑control impact assessments, and documenting stabil...