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 Director of Quality Control is responsible for all operational aspects of the Quality Control analytical testing organization at the Adaptimmune Philadelphia Navy Yard facility in support of raw material, in-process, final product, and stability testing. This individual plays a critical role in supporting method lifecycle management, including method transfers, validations and ongoing performance monitoring for testing performed at or for the Navy Yard Quality Control operations.
The QC Director ensures the compliance of QC operations with Adaptimmune policies, procedures and methods, including responsibility for QC related change control, CAPA and deviations.The QC Director is responsible for staff hiring, training and continued development of personnel within Quality Control. The Director of Quality Control The Director is responsible for assessing and monitoring the performance of the QC unit, including development of key performance metrics and identification of necessary improvement plans.Key Responsibilities
- Ensure employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports. (30%)
- Ensure management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs. (15%)
- Represent QC cross functionally with internal and external partners, including regulatory agencies (15%)
- Direct Quality Control operations for delivery of release and stability testing for Raw Materials, In Process, Lentiviral Vector and T-cell Drug Product tested at the Philadelphia Facility per target cycle times. (10%)
- Develop, monitor and report metrics for QC team performance, including improvement plans to meet missed performance targets (10%)
- Ensure robust laboratory investigations are performed to identify root cause for Out of Specification or unexpected results, including identification of corrective and preventive actions. (5%)
- Responsible for supporting analytical lifecycle management of test methods and instruments used at Philadelphia Facility including method validation, transfer, and method performance (5%)
- Development and management of ~$5M+ operating budget for department (5%)
- Support strategy development for content provided to regulatory agencies, provide review and approval for QC related content (5%)
- Additional management responsibilities as identified
Qualifications & Experience
Required
- Bachelor’s degree required, preferably in Chemistry, Microbiology, or related science. Advanced degree preferred.
- 12 years of relevant work experience required.
- 5 years of leadership experience with direct reports required.
- Strong knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
- Expertise in requirements for analytical methods, method transfer, qualification and validation for compendial and product specific analytical methods, stability, and QC release testing for advanced therapy
- Strong planning and resource management skills in a dynamic project environment located across multiple geographies.
- Strong communication and collaboration skills to build strong, empowered working team.
- Self-directed individual who can manage work with limited direction in a fast-paced, goal-oriented environment.
- Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences
- Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments
Desirable
- Proficiency in MS Office applications
- Understanding of statistical analysis of data
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.
