Associate Director, Vector Operations - London


Full-time

London, England, United Kingdom

Vector Operations

Associate Director, Vector Operations

Location: London, UK
Reporting to: VP, Vector Operations

The Company:

Orchard Therapeutics is a fully integrated, leading global commercial-stage biotech dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.

Partnering with world-leading research institutions in gene therapy, Orchard’s portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

Orchard is a publicly traded company (NASDAQ: ORTX) with offices in the UK and the US, including London, San Francisco and Boston.

The Role:

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.

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

Requirements

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:

  • Strong 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
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Fluency in French, German or Italian a plus

For further information on this role do not hesitate to email HR@orchard-tx.com

RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.