Senior Scientist-Stability Manager, QC
$100,000–$140,000 year
On-site · Coventry, Rhode Island, United States
Job Summary
Senior Scientist-Stability Manager, QC responsible for managing stability studies, drafting stability protocols and reports, and coordinating sample testing in a GMP QC environment. Will train and mentor junior QC scientists, review experimental data/notebooks/protocols/reports, investigate laboratory deviations (OOS/OOT) and write investigation reports, participate in cross-functional project teams, and ensure high-quality QC/analytical work with clear documentation per cGMP. Will participate in site audits, maintain Good Laboratory Practices, and assist with SOP development and revisions. Requires MS with 6-8+ years (or BS 8-10+ years) in pharma, stability program management experience, GMP QC compliance expertise, proficiency with HPLC/GC/FTIR/KF, and knowledge of FDA/EMA/ICH guidance.
Required Qualifications
- MS with 6-8+ years of experience or BS with 8-10+ years of experience in pharmaceutical industry
- Experienced in stability program management
- Expert in GMP QC compliance
- Experienced investigation of lab deviations, OOS, OOT and troubleshooting QC problems
- 3 years of experience with core analytical instrumentation such as HPLC, GC, FTIR, KF
- Evidence of ability to effectively contribute to multi-disciplinary scientific teams
- Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance
- Evidence of ability to effectively scientifically supervise staff
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.