Senior Scientist - Labs - QC Stability
Thermo Fisher Scientific
- Boston, MA
- Permanent
- Full-time
- Draft and revises stability protocols and reports, from initiation to finalization
- Creates and maintains stability schedules for GMP clinical stability studies, ensuring stability samples get pulled within appropriate timeline
- Coordinate with external testing labs to retrieve stability testing data and timepoint reports
- Initiate, document and address stability quality events, including change controls, deviations, and analytical investigations.
- Update stability related GMP documents (specifications, JoS, memos, etc.)
- Performs initiation and management of stability studies in LIMS and performs data entry and review.
- Support continuous improvement activities for stability program.
- Provide support to applicable stability sections of regulatory submissions.
- Present stability program updates to the Leadership Team.
- Perform stability data trending, as needed.
- Periodically review and update stability SOPs.
- Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
- Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
- OR Masters degree
- Past experience with Quality Control, preferably with focus on stability
- Good understanding of cGMP, GDP and GLP regulations and guidelines
- Knowledge of clinical and commercial QC stability regulations (FDA, EMA, ICH)
- General experience in data analysis and statistical evaluation/data trending