Role: Principal Scientist Stability overseeing stability strategies and programs for commercial large molecule biologics, including Drug Substances and Drug Products.
Responsibilities: lead stability program development and maintenance, author/study protocols, review stability reports and regulatory filings, support change controls, and represent stability in cross-functional projects. Manage stability data analysis, investigations, and stability-related regulatory responses. Collaborate with transfer teams, support health authority inspections, and streamline stability operations.
Qualifications: B.S. in Chemistry, Biology, Microbiology or similar; 8+ years in pharmaceutical stability or related fields. Expertise in ICH stability guidelines (Q1A, Q5C), cGMP regulations, and global regulatory requirements (US/EU/ROW). Knowledge of analytical/microbiology methods, stability data analysis using statistics software, and stability management systems.
Preferred: experience with biologics, post-approval stability, and external service providers.
High-value: biologics, large molecules, post-approval stability, global supply chain, regulatory submissions, and inspections.
Work setup: not explicitly stated.
#J-18808-LjbffrPrincipal Scientist Stability in new brunswick at Unknown Company
This position is listed as full time and onsite.