Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
The Quality Control Specialist will be responsible for the following:
- Perform daily GMP Quality Control laboratory testing activities
- Perform data analysis and result reporting to support product lot release with adherence to turnaround times.
- Support method transfers and method validation testing
- Support generation and revision of documentation, such as SOPs, protocols and reports, deviations, laboratory investigations, CAPAs and change controls.
- Support technical problem solving for issues pertaining to GMP QC activities
- Support product stability programs including execution of stability testing and stability data analysis
- Perform peer review and or technical review of laboratory data and logbooks
- Responsible for reagent inventory and equipment cleaning and maintenance
Key Responsibilities
- Execution of In-process, finished product, and stability samples
- Support method qualifications, technology transfer and method validations
- Author/Revise SOP’s and Test Methods, Deviations, CAPA’s and Change Controls
- Responsible for inventory and instrument/equipment maintenance
Qualifications & Experience
- Bachelor’s degree in molecular biology, biomedical sciences or related specialties
- Minimum of 2 years experience in the pharmaceutical industry working in a GMP quality control laboratory
- Experience with cell culture, aseptic technique, cell-based potency assays, and flow cytometry
- Proficient knowledge of GMP regulations including USP and EP testing requirements
- Intermediate experience conducting time critical testing of in-process and finished product to meet in process manufacturing needs
- Ability to author, review and maintain test methods, qualification protocols, SOPs and reports
- Conduct laboratory investigations, complete deviations, CAPAs and change controls as needed
- Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
Desirable
- 3+ years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus
- Ability to identify and implement continuous improvement projects for lab process efficiencies
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
