Director, Cell Therapy Operations (Europe) - London


London, England, United Kingdom

Cell Therapy Operations

Location: London, UK

Reporting to: Senior Vice President, Cell Therapy Operations

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for a Director, Cell Therapy Operations to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include the validation and execution of manufacturing processes at European Contract Manufacturing Organizations (CMOs) supporting OTL’s product programs in clinical trials and subsequent commercialization.



  • Manage the implementation and validation of cell isolation, cell culture and cell transduction processes and controls at company designated European CMOs
  • Manage the GMP production and distribution of gene-modified cell-based products to support clinical trials and commercial supply
  • Lead the reporting, investigation and resolution of deviations encountered during GMP production activities
  • Provide expert compilation, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports
  • Provide expert review and approval of executed batch, records, test records and associated documentation for release of gene-modified cell therapy products
  • Co-ordinate production activities with the QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones
  • Other activities as may be assigned

Job Requirements

As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry, this candidate will possess:

  • Extensive experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell and gene-based therapy products
  • In-depth technical experience with a proven track record of developing, integrating and implementing equipment and platforms for closed system:
    • Cell isolation/purification
    • Cell culture
    • Cell transduction
    • Cell washing/volume reduction
    • Formulation and final fill of cell-based products
  • Proven experience of the set-up, technology transfer and validation of manufacturing processes at CMOs
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • DOE, PAT and QBD experience a plus
  • This position requires frequent on site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite

Education & skills

  • A minimum BS or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Creative problem solver
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Fluency in French, German or Italian a plus