Associate, Vector Operations - London


Full-time

London, England, United Kingdom

Vector Operations

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.

Key Elements and Responsibilities

  • Support clinical vector production at CMOs
  • Review executed batch records
  • Participate in manufacturing investigations in collaboration with other departments
  • Provide person-in-plant support during production activities
  • Collect, Assemble, Analyze and Summarize Production data
  • Support activities related to process validation/qualification
  • Support development or optimization of vector production at CMO / CRO
  • Support technology transfer for existing/new programs
  • Work with QA, QC, Reg, CMC project management and other departments to advance programs
  • Support implementation of process changes
  • Contribute/Develop systems and procedures to manage/select CMOs

Requirements

Knowledge

  • Experience in the biotechnology industry with experience in cell culture, purification or fill finish (industrial placement experience can be counted)
  • Experience in GMP manufacture of vectors (or biologics) for pre-IND to phase III programs is preferred
  • Experience in MSAT, Process Development, validation, or Process engineering
  • Demonstrated sustained progression in career path

Skills & Abilities

  • Understanding of quality systems
  • Ability to work in a fast-paced environment
  • Good organizational skills
  • Good verbal and written communication skills
  • Flexibility and adaptability for re-prioritizing tasks
  • Ability to resolve production issues with creativity and within regulatory/quality guidelines
  • Ability to work with external partners effectively
  • Must be able to work in an environment where colleagues are in multiple time-zones
  • Ability to learn and apply new concepts
  • Bachelor’s degree or higher in Biology, Bio/Chemical Engineering, or related field
  • Good understanding of Biologic/Vector manufacture

Education