RESPONSIBILITIES

• 30% In-process, finished product and stability testing of clinical trial material
• 20%: Method / Technology Transfer of existing methods into the Adaptimmune QC Lab
• 20% Coordinate testing and maintenance of QC data from contract laboratories
• 20% Validation, verification and maintenance of quality control equipment
• 10% Maintenance of Quality Control Protocols, SOP’s and Test Methods

REQUIREMENTS

• Five to ten years working in a GMP quality control laboratory
• Proficient knowledge of GMP regulations including USP and EP testing requirements
• Experience conducting time critical testing of in-process and finished product to meet clinical trial needs.
• Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reports
• Conduct laboratory investigations and of prepare deviations and CAPAs as needed
• Ability to identify and implement continuous improvement projects for lab process efficiencies
• Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
• Ability to work on assigned projects independently with limited supervision.
• Familiarity with flow cytometry, ELISA, endotoxin testing
• Ability to independently coordinate testing activities at CMOs
• Method / Technology transfer experience
• Technical writing skills for drafting equipment and laboratory standard operating procedures