Principal Scientist, PSSM ARD, GMP Analytics, Stability Strategy & Operations
Pfizer · Groton, CT
QualityFull-time$106k–$177kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Pfizer's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.