Transport Validation, Scientist / Engineer.
We are looking for a Transport Validation scientist / engineer to join the Cell and Gene Therapy Technology Department to support commercialization of gene therapy products. This role requires someone with good knowledge of Transport Validation activities, who is keen to establish procedures in-house at Orchard Therapeutics. This will include use of risk-based procedures using appropriate tools to evaluate all aspects of the transportation process with understanding of the requirements for gene therapy products. You will work with cross functional teams, with treatment centres and with CMOs to generate documentation to support transport validation activities. You will support of Regulatory questions and Health Authority Inspections. In addition, support of process validation activities is included within this role, to ensure appropriate studies are executed and documented for product commercialisation.
Key Elements and Responsibilities
Establish transport validation procedures and templates to standardize approaches to preparation, execution and reporting of activities related to shipping and transport validation Lead / participate in multi-disciplinary teams to perform transport validation risk assessments and gap analyses of current and new routes Identify transport validation requirements, and work with Supply Chain and Operations to implement sustainable shipping controls, processes and methods in the evolving field of gene therapy products Perform transport validation studies in conjunction with vendors, CMOs and contract labs to ensure that products are shipped with compliant, efficient and cost-effective solutions Write and execute process and transport validation documentation, including project plans, validation master plans, protocols, reports and change controls Assess impact of any changes on validation status
Understanding of Transport Validation, with reference to in...