Director, Cell Therapy Operations (Europe) - London


Full-time

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.

Requirements

Responsibilities

  • 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