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.
Primary ResponsibilityThe QC Specialist, Raw Materials and Stability is a member of the Quality Unit who focuses on supporting the Quality Control stability and raw material program at Adaptimmune.Key Responsibilities
- Perform and/or coordinate testing for stability and raw materials as needed.
- Raw Materials-perform and/or facilitate testing at contract testing laboratories (CTL). Summarize data generated from CTL internally to support material release.
- Stability-perform stability testing on T-Cell final product as needed. Schedule/review of stability testing.
- Author internal documents summarizing data generated for raw materials and stability samples as needed.
- Assist in document revision/authorship as needed.
- SOP’s, material specifications, protocols, and reports.
- Assist in execution of deviations, change controls, and CAPAs as needed.
- Assist in data integrity checks and internal audits.
- Assist in program improvements such as design/implantation of templates within LIMS.
- Assist in the qualification of critical ancillary and excipient raw materials used in the GMP manufacturing process.
Qualifications & Experience
Required
- Bachelor’s degree in Biological Sciences or science related field with 2-3 years of relative experience.
- Experience working in a GMP facility.
- Experience performing/reporting QC testing.
- Experience with technical writing such as authoring/revising SOP’s, study protocols and reports, specification, Certificate of Analysis, etc.
Desired
- Previous experience working in a GMP laboratory.
- Quality documentation systems such as LIMS, MasterControl, PAS-X, and/or Veeva.
- Performance of analytical methods such as flow cytometry, PCR, potency, and USP/compendial.
- Understanding of raw material and stability programs within the QC department.
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.
