Astellas Pharma Quality Control Specialist, Technical Operations in Marlborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and is focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.
AIRM is seeking a highly motivated individual to join us as a Quality Control Specialist. This position provides Quality Control (QC) testing of in-process and final product testing. Looking for experience with cell culture, RT-qPCR, Immunofluorescence, cell based assays etc.
- Perform routine in-process and release QC testing of AIRM cell products
- Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting
- Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays
- Track and test products according to stability protocols
- Work with internal and external resources to maintain lab in an optimal state
- Monitor and trend data
- Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
- Generation of CoAs for product release
- Develop, revise and review SOPs, qualification/validation protocols and reports
- Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Perform other lab duties as required
- This position interacts with QC and AD management
- Will contribute to the development of QC departmental processes
- Bachelor's or Master's degree in biotechnology or related field with minimum 1 year of Quality Control experience
- Knowledge of GMP, SOP's and quality control process
- Proficient in MS Word, Excel, Power Point and Outlook
- Strong written and verbal communication skills
- Experience in the biotech and/or pharmaceutical industry
- Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be occasional weekend work
The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Technical Operations