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
Adaptimmune is seeking a Quality Engineering Sr. Specialist to provide Quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and Adaptimmune’s validation practices and procedures.
The Sr. Specialist assists with defining qualification & validation strategies and to ensure the necessary documents (i.e. plans, protocols, and reports) to satisfy both internal and external standards are generated appropriately.
Key Responsibilities
- Responsible for QA review and approval of all validation records and documentation (i.e. process validation, computer system validation, and equipment lifecycle documentation including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ, and PV protocols and reports)
- Assist in the monitoring of quarterly reports, periodic reviews and/or revalidation of equipment and processes.
- Review and approve protocol discrepancies related to manufacturing process equipment, utilities, computer systems, validation, and laboratory instruments. (5%)
- Ensure GMP compliance in all areas of validation/qualification and that systems are fully validated/qualified and all documentation completed before they are released for GMP use.
- Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner.
- Review the content of technical lifecycle documentation (i.e. Characterization Study Protocols/ Reports, QTPP, PPQ Protocols/Reports, Control Strategy Documents, etc) ensuring compliance with the validated state of the process.
- Collaborate on the Aseptic Process Validation strategies, assessments and protocols to ensure the Navy Yard manufacturing facility remains compliant. (5%)
- Assist with the Data Integrity Audit Trail Review implementation at the Navy Yard Site.
- Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation.
- Support process improvement & change management initiatives by assessing impact to the validated state of the process and equipment. Participate in efforts to identify opportunities for and to implement continuous improvement of practices related to validation.
- Maintain inspection readiness and actively support regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors.
- Stay current with industry trends and standards (PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
- Participate in routine plant operating meetings (CAPA, Deviation, Change Control) and serve as Quality Engineering SME.
Required
Qualifications & Experience
- Bachelor’s Degree in Science or related technical field.
- Minimum of 5+ years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.
- Must demonstrate understanding of cGMP’s, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations.
- Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
- Strong knowledge of global regulatory requirements for Clinical and Commercial GMP computerized systems validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
- Knowledge of Quality Risk Management principles and experience with performing risk assessments using a variety of tools, i.e. FMEA.
- Must be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks.
- Must possess strong verbal/written communication skills and ability to influence at all levels.
- Experience utilizing quality systems to support Quality Engineering activities (Document management, Training, Deviation management, Change Control management, and CAPA).
- Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
Desirable
- Experience with Calibration manager databases, Electronic Lab Notebooks, Veeva, Validation Data Acquisition systems (ie Kaye, Ellab, TempTale), Building Management systems, Document Control Software
- Experience with leading the start-up, validation, and licensure of manufacturing facilities.
- Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process validation).
- Experience working with cell and gene therapies or biologics products.
- Experience working with external parties and/or leading cross-functional teams.
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.
