Manager, Vector Manufacturing/Technology Transfer - VO5


Full-time

Menlo Park, California, United States

Vector Operations

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.

The vector operations group within Orchard is responsible for the production of clinical and commercial supply of vector to support our autologous ex-vivo gene therapies. This field is at the cutting edge of gene therapy and we are rapidly expanding. We are actively searching for experienced and motivated bioprocess professionals to join our team and contribute to our exciting growth. This particular role will be involved with Technology Transfer for manufacturing processes going into our new facility. The candidate will also be involved with manufacturing sciences to ensure processes are transferred appropriately and/or find solutions to any inconsistencies.

Responsibilities

  • Lead Technology transfer from internal and external development sources to our internal manufacturing group
  • Establish Tech transfer systems for efficient transfer and identifying critical tasks
  • Lead manufacturing deviations and investigations
    • Design and execute experiments to support investigations
  • Develop process descriptions of vector manufacturing process steps
  • Support startup of initial manufacturing by reviewing Unit Operations Reports and SOPs
  • Become a vector bioprocess SME
  • Train/educate new manufacturing staff
  • Provide floor support during facility startup
  • Contribute to/Develop systems and procedures to manage Process development and manufacturing sciences

Requirements

  • Minimum of 5 years in the biotechnology industry with experience in cell culture, purification, fill-finish, and technology transfer.
  • Experience in GMP manufacture of vectors (or biologics)
  • Good understanding of and ability to create GMP manufacturing processes and work flows
  • Ability to resolve production issues with creativity and within regulatory/quality guidelines
  • Ability to work with multiple departments effectively
  • Ability to manage others effectively
  • Excellent verbal and written communication skills
  • Ability to learn and apply new concepts quickly
  • Experience in MSAT, Process Development, validation, or Process engineering

Education & Skills

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