Senior Manager EU Cell Therapy Operations - Innovative Gene Therapy St

Orchard Therapeutics
United Kingdom
01 Mar 2018
18 Mar 2018
Contract Type
Full Time
Location: London, UK Reporting to: AD, 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 Sr Manager EU 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 transfer and oversight of manufacturing processes and controls to support OTL's product pipeline programs from pre-clinical research through to commercialization Responsibilities 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 Lead the reporting, investigation and resolution of deviations encountered during GMP production activities Provide expert compilation, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports Provide expert review and approval of executed batch, records, test records and associated documentation for release of gene-modified cell therapy products Participate in internal development and validation of platform manufacturing process and associated controls for commercialization of company's products Co-ordinate production activities with the pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones Other activities as may be assigned. Job Requirements 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 is required 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

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