Senior Manager EU Cell Therapy Operations - Innovative Gene Therapy Start Up

London, England, United Kingdom
Feb 23, 2018
Required Education
Bachelors Degree
Position Type
Full time

Location: London, UK

Reporting to: AD, 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 Sr Manager EU 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 transfer and oversight of manufacturing processes and controls to support OTL’s product pipeline programs from pre-clinical research through to commercialization


  • Manage the transfer of cell isolation, cell culture and cell transduction processes and controls from academic collaborators and/or internal departments to company designated Contract Manufacturing Organizations (CMOs) or academic sites
  • Provide oversight for the GMP production, testing and distribution of gene-modified cell-based products at EU CMOs and academic sites
  • 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
  • Participate in internal development and validation of platform manufacturing process and associated controls for commercialization of company’s products
  • Co-ordinate production activities with the pre-clinical development, 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 and technology transfer of manufacturing processes and controls to both domestic and international CMOs is required
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • DOE, PAT and QBD experience a plus
  • The ability to travel domestic and international

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