Senior Associate, Vector Operations - VO2


Full-time

London, England, United Kingdom

Vector Operations

The Role of Senior Associate Vector Operations will join a small team of Vector Operations professionals based in London and will have the opportunity to work with cutting edge science in the rare disease field. Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare disease through innovative gene therapies.

Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion-dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.

Requirements

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
  • Manage/Perform technology transfer for existing/new programs
  • Work with QA, QC, Reg, CMC project management and other departments to advance programs
  • Manage implementation of process changes
  • Contribute/Develop systems and procedures to manage/select CMOs
  • Minimum of 5 years 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 is preferred
  • Experience in MSAT, Process Development, validation, or Process engineering
  • Demonstrated sustained progression in career path

Required knowledge

Skills & Abilities

  • Good CMO/vendor relationship management skills
  • Good 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 GMP manufacture

Education

  • Bachelor’s degree or higher in Biology, Bio/Chemical Engineering, or related field
  • Good understanding of Biologic/Vector GMP manufacture