Manager EU, Cell Therapy Operations - CTO13
London, England, United Kingdom
Cell Therapy 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.
Reporting to: Senior Manager EU, Cell Therapy Operations
The CMO Manager will manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include the transfer and oversight of manufacturing processes and controls to support OTL’s product pipeline programs from pre-clinical research through to commercialization.
- Manage the transfer of cell isolation, cell culture and cell transduction processes and controls from academic collaborators and/or internal departments to company designated Contract Manufacturing Organizations (CMOs) or academic sites
- Provide oversight for the GMP production, testing and distribution of gene-modified cell-based products at EU CMOs and academic sites
- Review and approve executed batch records, test records and associated documentation for release of gene-modified cell therapy products
- Lead the reporting, investigation and resolution of deviations encountered during GMP production activities
- Track and trend manufacturing run data
- Provide person-in-plant support for manufacturing runs
- Review, edit and approve master production records, standard operating procedures, development/validation protocols and reports
- Participate in cross-functional activities with Process Development, Process Validation, Quality Assurance, Quality Control, Analytical Operations, Clinical Development, and commercial departments to ensure the successful achievement of company timelines and milestones
- Support the internal process development and validation of platform manufacturing process and associated controls for commercialization of company’s products
- Other activities as may be assigned
The ideal candidate for this position must have experience in the manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry.
Candidate must possess:
- A BS or equivalent in bioprocessing, medical technology, chemical engineering, or biological sciences
- Extensive experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products
- Experience with technology transfer of manufacturing processes and controls at CMOs is advantageous
- Knowledge of FDA, EMA, GMP and ICH regulatory requirements
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- This position requires on site person-in-plant presence at CMOs and contract vendors on a potential global basis. Therefore, ability to travel is a prerequisite.