Principal Scientist, PSSM ARD, GMP Analytics, Stability Strategy & Operations
$106k - $176.6kPfizer Inc
Principal Scientist role in pharmaceutical stability strategy and analytics at Pfizer. Develop scientifically sound stability strategies for drug development programs from clinical through registration phases, lead cross-functional initiatives, and provide technical expertise in GMP analytics and regulatory submissions.
Responsibilities
- Develop and communicate phase-appropriate stability strategies for drug substance and product programs
- Design stability protocols, oversee testing conditions and schedules, assess data trends and compliance risks
- Author and review stability protocols, technical reports, regulatory submissions and CMC documentation
- Coordinate stability activities across internal and external laboratories and testing partners
- Support GMP investigations, deviations, audits and health authority responses involving stability topics
Requirements
- BA/BS with 12+ years relevant experience; MS/MBA with 9+ years; or PhD with 4-8 years
- Pharmaceutical analytical development, stability sciences, or product quality in regulated GMP environment
- Strong understanding of ICH stability guidance and pharmaceutical stability principles
- Ability to interpret complex analytical data and communicate clear scientific conclusions
- Experience in cross-functional, matrixed team environments
- Strong technical writing and presentation skills
- Proficiency with software systems and ability to learn new technologies
Vacancy posted 29 days ago
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