Overview In this role you will manage stability studies for vaccine and pharmaceutical products, coordinating sample handling, protocol creation, and study closeouts. You will work with cross-functional teams across internal and partner sites to ensure GMP-compliant documentation and timely issue resolution. The position focuses on maintaining stability programs, supporting deviations, and driving continuous improvement initiatives. This is an opportunity to contribute to high-quality, compliant stability operations in a global setting with a strong emphasis on cross-site collaboration.
Compensation / Benefits- medical, dental, vision insurance
- retirement benefits including 401(k)
- paid holidays and vacation
- compassionate and sick days
Responsibilities- Manage stability studies for vaccines and pharmaceutical products, including sample handling, labeling, chain of custody, protocol creation, study builds, and closeouts
- Coordinate sample shipment and receipt with partner sites and labs
- Review annual stability reviews for licensed products for accuracy
- Respond to product or project inquiries in a timely manner
- Maintain GMP documentation per company policies and procedures
- Support deviation management and implementation of corrective actions related to stability operations
- Respond to early warning limit excursions
- Author or revise local Standard Operating Procedures
- Utilize Laboratory Information Management System and software tools for data handling and reporting
Key requirements- Bachelor's degree in chemistry, Biological Science, Pharmacy, or related Science or Engineering field
- Experience in laboratory, technical services, manufacturing, regulatory and/or quality roles (preferred)
- Working knowledge of analytical methods, GMP compliance
- Experience with vaccines, biologics, and/or devices (preferred)
- Familiarity with LIS, QA, and documentation practices
- Adaptability
- Interpersonal relationships
- Decision making
- Laboratory Information Management System (LIS)
- GMP Documentation
- Data analysis
