Manager, Vector Manufacturing/Technology Transfer - VO5


Full-time

Menlo Park, California, United States

Vector Operations

Orchard Therapeutics Limited is a global biotechnology company dedicated to bringing transformative gene therapies to children with severe and life-threatening orphan diseases. The company has been founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.

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

  • Bachelor’s degree or higher in Biology, Bio/Chemical Engineering, or related field
  • 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
  • Experience in MSAT, Process Development, validation, or Process engineering
  • 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
  • Good understanding of quality systems
  • Flexibility and adaptability for re-prioritizing tasks

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plan. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k).

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

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.