General Purpose of the job:
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.
Duties and 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.
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.
Working Conditions and Physical Effort:
- Ability to remain in a stationary position (e.g., standing or sitting) for extended periods.
- Ability to move within facility environments, including accessing testing areas and operating instrumentation.
- Work may occasionally take place in controlled radiation areas under supervision and within regulatory exposure limits.
- Use of personal protective equipment (PPE), lab coats, safety glasses, and dosimeters.
- Work environment involves some exposure to hazards or physical risks, which require following basic safety precautions.
- Although flexible work hours may be available, shift-work schedules may be required, and extended hours will sometimes be necessary to complete required work assignment.
Employees must be able to perform the essential functions of the position satisfactorily. If requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.
Employees must be able to perform the essential functions of the position satisfactorily. If requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. Management reserves the right to change, rescind, add or delete the duties and responsibilities of positions within this job at any time.
SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.
SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.