Director, Cell Therapy Operations

Location
Foster City, California
Posted
Oct 17, 2017
Required Education
Bachelors Degree
Position Type
Full time

Location: Foster City, California

Reporting to: Vice President, Cell Therapy Operations

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for a Director, Cell Therapy Operations to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include the development, scale-out, validation and execution of manufacturing processes and controls to support OTL’s product pipeline programs from pre-clinical research through to commercialization.

  1. Manage the transfer of cell isolation, cell culture and cell transduction processes and controls from academic collaborators to company designated Contract Manufacturing Organizations (CMOs)
  2. Manage the GMP production, testing and distribution of gene-modified cell-based products at CMOs
  3. Lead the reporting, investigation and resolution of deviations encountered during GMP production activities
  4. Provide expert compilation, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports
  5. Provide expert review and approval of executed batch, records, test records and associated documentation for release of gene-modified cell therapy products
  6. Establish appropriate internal infrastructure to provide development and validation of platform manufacturing process and associated controls for commercialization of company’s products
  7. Co-ordinate production activities with the research, pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones
  8. Other activities as may be assigned

As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry, this candidate will possess:

  • Extensive experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell and gene-based therapy products
  • In-depth technical experience with a proven track record of developing, integrating and implementing equipment and platforms for closed system:
    • Cell isolation/purification
    • Cell culture
    • Cell transduction
    • Cell washing/volume reduction
    • Formulation and final fill of cell-based products
  • Proven experience of the set-up and technology transfer of manufacturing processes and controls to both domestic and international CMOs
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • DOE, PAT and QBD experience a plus

The ability to travel domestic and international

Education & skills

  • A minimum BS or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Creative problem solver
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment