Manager, Vector Operations - VO3


Full-time

London, England, United Kingdom

Vector Operations

Manager, Vector Operations

Location: London, UK

Reporting to: Associate Director, Vector Operations

The Company:

Orchard Therapeutics is a leading global, fully integrated, 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.

Job summary

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.

Key Elements and Responsibilities

  • Manage/Support clinical vector production at CMOs
  • Edit, Review, and Approve Master/Executed batch records and material specifications
  • Participate/Lead manufacturing investigations in collaboration with other departments
  • Provide person-in-plant support during production activities
  • Collect, Assemble, Analyze and Summarize Production data
  • Contribute to Regulatory Filings as needed
  • Support activities related to process validation/qualification
  • Manage/Perform technology transfer for existing/new programs
  • Work with QA, QC, Reg, CMC project management and other departments to advance programs
  • Develop and Manage change controls
  • Manage implementation of process changes
  • Contribute/Develop systems and procedures to manage/select CMOs
  • Help arrange international shipment of vectors/biologics

Requirements

Required knowledge

  • Strong experience in the biotechnology industry with experience in cell culture, purification or fill finish
  • Experience in GMP manufacture of vectors (or biologics) for pre-IND to phase III programs
  • Experience in MSAT, Process Development, validation, or Process engineering
  • Demonstrated sustained progression in career path
  • Ability to resolve production issues with creativity and within regulatory/quality guidelines
  • Ability to manage vendors effectively
  • Good verbal and written communication skills
  • Must be able to work in an environment where colleagues are in multiple time-zones
  • Ability to learn and apply new concepts

Education

  • Bachelor’s degree or higher in Biology, Bio/Chemical Engineering, or related field
  • Good understanding of Biologic/Vector GMP manufacture
  • Good CMO/vendor relationship management skills
  • Good understanding of quality systems
  • Ability to work in a fast-paced environment
  • Good organizational skills
  • Good communication skills
  • Flexibility and adaptability for re-prioritizing tasks

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.


Notice to All Applicants:
Orchard Therapeutics participates in E-Verify