Principal Engineer/Scientist, Process Validation

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 To Lead lifecycle activities associated with the production of personalized cell therapy drug products. The Principal Engineer will play a critical role in the establishment of control strategies for Adaptimmune's cell therapy products; Drive qualification & validation strategies and develop the necessary documents (e.g. plans, protocols, and reports) to satisfy both internal and external standards; Matrix manage projects collaborating with Process Development, Analytical Development, QCAST, Manufacturing, and Quality Assurance teams Key Responsibilities Manage the execution of process validation activities including designing protocols and studies (i.e. extractables & leachables, shipping validation, container closure integrity) Support the implementation of process control strategies by collaborating with Process Development, Manufacturing, and Quality Assurance. Establish normal operating ranges (NORs) and proven acceptable ranges (PARs) for drug product manufacturing process parameters, hold times, and material attributes. Ensure control strategy content is developed to facilitate regulatory submissions including IND, IMPD, MAA, and BLA. Effectively communicate scientific data and results across technical teams and project teams. Lead the development of strategies, plans, and protocols for Process Performance Qualification (PPQ) of drug product manufacturing processes. Oversee the execution of PPQ activities and develop PPQ reports. Ensure that PPQ activities are documented compliantly. Support process improvement & change management initiatives by assessing impact to the validated state of the process. Support technical transfer projects and continuous improvements for the manufacture of Adaptimmune products. Participate in efforts to identify opportunities for and to implement continuous improvement of practices related to validation. Apply risk management tools and principles throughout the process validation lifecycle. Oversee technical transfer of existing processes between internal and external manufacturing sites. Stay current with industry trends and standards (PDA, ISPE) and participate in best practice forums consistent with function responsibilities. Participate in routine operating meetings and serve as Validation SME. Qualifications & Experience Required M.S (Science or Engineering) and 5 years of relevant experience or B.S. (Science or Engineering) and 7 years of relevant experience in the biopharmaceutical industry. An equivalent combination of education and experience with cell and gene therapies will be considered. Expert Knowledge of cGMP's, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations. Expert Knowledge for application of a lifecycle approach (process design, process qualification) 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 communication skills and ability to influence at all levels. Strong technical documentation skills. Experience utilizing quality systems to support process characterization activities (Document management, Change Control management, and CAPA). Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies. Desirable Proficient with the use of statistical analysis software (i.e. JMP, Minitab) other requirements The primary work location is Philadelphia, PA site. Some domestic and/or international travel may be required to provide oversight of Process Validation activities at CMOs or at Adaptimmune's facilities in the UK. ( 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.

Created: 2024-10-20