Senior Stability Specialist, Quality Control
About The Position
The GMP Senior Stability Specialist serves as the technical subject matter expert for GMP stability programs and is responsible for the coordination, execution, and monitoring of stability programs in compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements (e.g., ICH, FDA). The Senior Stability Specialist ensures that stability studies are designed, implemented, and maintained to support product shelf life, regulatory filings, and ongoing product quality. The Senior Stability Specialist works cross-functionally with Quality Control, Quality Assurance, Manufacturing, and Regulatory Affairs to ensure data integrity and timely reporting of stability results. This position is based in Massachusetts and requires presence on-site 5 days per week. The base salary range for this position is $110,000-$125,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.
Requirements
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences or related scientific field (Master’s preferred).
- Minimum 5-8 years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Experience with stability programs, QC laboratory operations, or analytical testing preferred.
Nice To Haves
- Master’s degree in Chemistry, Pharmaceutical Sciences or related scientific field.
Responsibilities
- Lead the design, implementation, and lifecycle management of complex stability programs for commercial, clinical, and development products.
- Serve as the Quality Control Stability Subject Matter Expert (SME) during regulatory inspections, client audits, and internal audits.
- Independently assess stability data and provide scientific recommendations regarding product shelf-life, retest periods, storage conditions, and regulatory commitments.
- Perform advanced statistical analysis and trend evaluations to identify emerging product quality risks.
- Lead investigations related to stability OOS, OOT, atypical results, and stability-related deviations.
- Author and approve stability protocols, reports, risk assessments, technical justifications, and regulatory support documents.
- Evaluate stability impact assessments associated with manufacturing changes, process improvements, raw material changes, and product transfers.
- Drive continuous improvement initiatives to enhance stability program efficiency, compliance, and data integrity.
- Support implementation and validation of stability management systems and associated electronic platforms.
- Provide technical guidance and mentorship to junior specialists, analysts, and cross-functional teams.
- Support regulatory submissions, annual reports, product quality reviews, and health authority responses.
- Participate in establishing departmental policies, procedures, and best practices related to stability management.
- Lead cross-functional projects involving method transfers, product launches, validation studies, and lifecycle management activities.
- Review and approve stability documentation as delegated by management.
Benefits
- Comprehensive compensation package
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What This Job Offers
Job Type
Full-time
Career Level
Senior
