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Quality Lifecycle Management Lead (Validation)

SUMMARY

Adaptimmune is seeking a Lead within the Quality Lifecycle Management/Validation team to focus on the validation of processes for the development, manufacture, and distribution of Adaptimmune products within the rapidly growing Quality unit.

   

RESPONSIBILITIES

  • Develop and implement policies and procedures related to product and process lifecycle management of Adaptimmune assets within the Quality organization. 
  • Management of the integration of programs and activities for the Quality product lifecycle.  Support the implementation of the product and process lifecycle approach for Adaptimmune manufacturing processes.  Manage and support cross-functional team projects, as required. 
  • Support the development, implementation, and revision of corporate quality systems.  Track and trend quality system metrics related to batch execution and the quality systems.   
  • Write and review quality and technical documentation (e.g., batch records, SOPs, validation plans/protocol/reports, CMC sections for regulatory filings).    
  • Support technical transfer projects and continuous process improvements both internal (development to manufacturing) and site to site including at contractor manufacturing organizations for the manufacture and testing of Adaptimmune products. 
  • Coordinate projects with cross-functional teams working closely with Quality Assurance, Manufacturing/Technical Operations, Process Development, Quality Control, and Regulatory CMC.
  • Support the risk-based approach to qualification of product shipping/transport of products and intermediates to maintain product quality through the distribution chain.
  • Provide company representation at regulatory and industry organizations involve in the setting of standards for cell therapy process validation and other quality systems.
  • In collaboration with Quality Control, maintain the analytical instrument validation and support establishment and management of specifications related to product lot release, in-process, stability, and raw materials testing.
  • Participate in efforts to identify opportunities for and to implement continuous improvement of practices related to validation and the quality product and process lifecycle.

 

REQUIREMENTS

  • Degree in biochemical engineering, biotechnology, or life sciences with a minimum of 5 -8 years of biotechnology/cell therapy/aseptic processing manufacturing, process development, and/or validation experience.
  • Previous experience with cell therapy products is a plus.
  • Must have a knowledge of GMPs, global regulatory guidances, 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.
  • Apply proven communication, analytical, and problem-solving skills to help identify, communicate, and resolve issues
  • 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.
  • Experience data management systems and tools.  Knowledge of statistical analysis methodology of quality related data (e.g., JMP, Minitab, SQL).
  • 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.
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