Associate Director/Principal Scientist, Cell and Gene Therapy Technologies

Orchard Therapeutics ,
London, Greater London
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Job Description

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 Principle Scientist to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include process development, external tech-transfer, and scale-out of HSC-based gene-modified autologous cell products from pre-clinical research through to commercialization. The post-holder will also input into validation and GMP execution of manufacturing processes and controls to support OTLs product pipeline programs. The job position is for Associate Director or Principal Scientist, depending on experience. Key Elements and Responsibilities * Manage the transfer of cell processes and controls from academic and external collaborators to the cell processing team. * Design and implement improvements in processes and characterize HSC-based gene modified cell processes to deliver robust platform processes suitable for early and late-stage clinical and commercial development. * Provide expert compilation, review, editing and approval of batch records, standard operating procedures, investigations, development protocols and reports. * Provide guidance and direction on experiments and reports required and suitable for regulatory submissions. * Co-ordinate development activities with the research, pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones. * As required, assist with oversight of manufacturing at company designated Contract Manufacturing Organizations (CMOs). * Other activities as may be assigned. Requirements Required knowledge 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: * Minimum of 3 years of 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 processes for clinical and/or commercial application: * Cell isolation/purification * Cell culture * Cell transduction * Cell washing/volume reduction * Formulation and final fill of cell-based products * In depth expertise of gene therapy vectors and autologous gene modified cellular therapies * Experience with regulatory filings and associated reports/sections writing. In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements * Experience with process characterization and comparability strategies * DOE and QBD experience a plus * The ability to travel domestic and international * Experience in GMP preferred * Experience authoring regulatory documents preferred * 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 Skills & Abilities * Experience in GMP preferred * Experience authoring regulatory documents preferred * 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 Education * A minimum PhD or equivalent, in bioprocessing, biological sciences, gene therapy

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