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 Responsibility
This is an onsite role in our Philadelphia Navy Yard site.

The Quality Control Specialist will be responsible for conducting /coordinating in-process environmental monitoring of cGMP suites, finished product safety tests (endotoxin, sterility), and stability testing associated with Adaptimmune drug products. This individual is generally considered the Subject Matter Expert (SME) on environmental monitoring and drug product safety tests.  This role has the ability to operate independently and troubleshoot issues associated within the quality control laboratory.

Key ResponsibilitiesIn-process environmental monitoring, finished product testing and stability testing.Maintenance of Quality Control Protocols, SOP’s and Test MethodsDeviations, change controls, CAPAsMethod / Technology Transfer of existing methods into the Adaptimmune QC LabEnsuring daily schedule is maintained for QC operations
Qualifications & Experience

RequiredBachelors of Science degree in a Scientific discipline3-5 years working in a cGMP quality control microbial laboratoryAdvanced knowledge of cGMP regulations including USP and EP testing requirementsAdvanced experience conducting time critical testing of in-process and finished product to meet clinical trial needs.Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reportsConduct laboratory investigations and of prepare deviations and CAPAs as neededAbility to identify and implement continuous improvement projects for lab process efficienciesAbility and desire to effectively work independently or in an interdisciplinary team environmentEffectively interact at multiple levels within the company to support internal manufacturing capabilitiesDesirablePrevious Gown Qualification for aseptic processing experienceAbility to work on assigned projects independently with limited supervision.Advanced knowledge with rapid microbiology methods, Endotoxin testing, and EM monitoringExperience using MODA and LIMS software
 

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.