Associate Director, Vector Operations - London


Full-time

London, England, United Kingdom

Vector Operations

Location: London, UK

Reporting to: Senior Director, Vector 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 an individual to join a London-based team responsible for activities related to the development and cGMP production of lentiviral vectors at European contract manufacturing organizations (CMOs). Such activities will include the scale-up, validation and execution of manufacturing processes and controls to support Orchard Therapeutics innovative cell and gene therapy product programs from Phase I clinical trials through to commercial.

Requirements

Responsibilities

  • Manage the GMP production, testing and fill finish of lentiviral vectors at CMO's
  • Drive activities for the DoE, protocol generation, execution and reporting of studies to validate production processes and associated assay method controls to support BLA/MAA submissions for company products
  • As required, provide on-site person-in-plant oversight during production campaigns and key development/validation activities
  • Assist in 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 lentiviral vector lots and for plasmid lots used in their production
  • Other activities as may be assigned

Job Requirements

The ideal candidate for this position will have demonstrated experience of the large-scale cGMP production of lentiviral vectors, including upstream cell culture, downstream processing, and fill finish operations.

Candidate must possess:

  • Extensive experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, downstream processing, and fill finish operations for biologics
  • In depth knowledge of lentiviral vector construction and biology
  • In-depth experience of the large-scale cGMP production of lentiviral vectors, including
    • Upstream cell culture, downstream processing, and fill finish operations
    • Process characterization and validation
  • Proven track record of managing lentiviral vector development, validation and production both in-house, and at CMO’s/partners
  • Demonstrated ability to build and lead technical teams in fast-paced operational environments
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements for biologics
  • Knowledge of Quality Systems, QBD and PAT as they relate to GMP production operations, process optimization and process validation
  • This position requires on site person-in-plant presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite

Education & skills

  • Minimum BSc or equivalent in bioprocessing, chemical engineering, vector biology, or biological sciences
  • Experience of managing CMO relationships and projects
  • Working knowledge of US and European regulatory requirements
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Fluency in French, German or Italian a plus
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills