RESPONSIBILITIES

• Manage the execution of process validation activities including designing protocols and studies, evaluating process and assay data, investigating protocol deviations and acceptance criteria failures, and compiling final summary reports.
• Develop, document, and implement process validation master plans utilizing a product & process lifecycle approach compliant with Regulatory authority guidance and industry best practices.
• Develop and manage a risk-based approach to the design and execution of aseptic process simulations performed for manufacturing processes.
• Support the implementation of the product and process lifecycle approach to Adaptimmune manufacturing processes by working with Process Development and Manufacturing Science and Technology units. Apply risk assessment throughout the process validation lifecycle.
• Support technical transfer projects and continuous process improvements at contractor manufacturing organizations for the manufacture of Adaptimmune products.
• Manage analysis of manufacturing data and support development of database for the collection, control, and access of key process and development data.
• Support the risk-based approach to qualification of product shipping/transport of products and intermediates to maintain product quality through the distribution chain.
• Coordinate projects with cross-functional teams including Quality Assurance, Manufacturing/Technical Operations, Process Development, Quality Control, Regulatory CMC.
• Participate in efforts to identify opportunities for and to implement continuous improvement of practices related to validation.
• Up to 20% travel.

QUALIFICATIONS

• BS or MS degree in Engineering with a minimum of 5 years direct work experience in Validation within a Quality unit.
• Must have a knowledge of GMPs, regulatory guidelines, and best industry practices. Strong understanding of the application of a process validation lifecycle approach (process design/process qualification/on-going process monitoring).
• Must be able to prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
• Must be able to work well on cross-functional teams, as well as perform independently.
• Must have excellent technical writing and verbal communication skills.
• Strong knowledge of Quality Risk Management and experience with performing risk assessments using a variety of tools, e.g. FMEA, HACCP.
• Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process simulations).
• Excellent written and verbal communication skills
• Must be able to work well on cross-functional teams, as well as perform independently.
• Able to manage multiple priorities
• Strong organizational and project planning skills.