Manager, Vector Production - VO3


Full-time

London, England, United Kingdom

Vector Operations

Location: London, UK

Reporting to: VP, Vector Operations

The Manager, Vector Production will assist in the oversight activities related to the development and cGMP production of lentiviral vectors at 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

  • Assist with the transfer of plasmid and lentiviral vector production processes and controls from academic collaborators to company designated CMO’s
  • Help to coordinate and manage the GMP production, testing and fill finish of lentiviral vectors at CMO's
  • Provide on-site person-in-plant oversight during production campaigns and key development/validation activities
  • Assist with 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
  • Help to co-ordinate production activities with the research, pre-clinical development, QA, QC, clinical development, commercial and project management departments to ensure the successful achievement of company timelines and milestones
  • Ensure the ongoing security of the supply chain for raw materials and intermediates to assure the uninterrupted performance of lentiviral production operations and provision of material for pre-clinical, clinical and commercial programs
  • Other activities as may be assigned

Benefits

Job Requirements

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

Candidate must possess:

  • BS or MS in bioprocessing, chemical engineering, vector biology, or biological sciences
  • Ability to work independently or with minimal oversight
  • Strong experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, transfection, downstream processing, and fill finish operations for viral vectors and/or biologics
  • Proven track record of working in development, validation and production operations
  • Experience with:
    • Mammalian cell and microbial cell culture systems
    • Different bioreactor production systems and scales, including disposable single-use bioreactor systems
    • Validation of manufacturing processes and controls
  • Knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • Knowledge of Quality Systems and QBD as they relate to GMP production operations, process optimization and process validation

Other Requirements

  • This position requires on site person-in-plant presence at CMO’s and contract vendors on a potential global basis. Therefore, ability to travel is a pre-requisite
  • Personnel and project management skills
  • Organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Experience of facility, and production equipment design and validation, including IQ, OQ & PQ preferred