The QC Chemistry Supervisor will be Responsible for supervising all internal and outsourced QC laboratory operations. Provide the primary technical support for the QC laboratory and ensure that all testing and investigation resolutions are performed in a high quality and timely manner. Responsible for supervising the stability programs, and the release of drug substances, and finished drug products
Responsibilities
- Chemistry quality control testing of in-process, finished product products and stability samples.
- Oversee laboratory testing, including investigations, deviations, and troubleshooting in a technical and supervisory role.
- Coordinate scientists’ activities to ensure that all testing and calibrations are completed according to schedule and meet all CGMP requirements.
- Monitor instrument qualifications.
- Ensure that qualifications of analytical instruments are up to date and meet regulatory requirements.
- Develop test protocols, review and write technical reports, write SOP’s, and review stability data.
- Work closely with QA to implement procedures in compliance with regulatory requirements
Requirements
- Bachelor’s or Master’s degree in Chemistry or related field
- 5 years of experience in sterile pharmaceutical and/or biotechnology drug product testing
- Supervisory experience in the pharmaceutical / biotechnology / medical device field
Benefits
- Employer sponsored health and dental
- 15 days paid time off (to start)
- 401k + company matching
- Tuition Reimbursement
- Short term disability insurance
- Profit sharing plan
- Travel insurance