Scientist I

Location: London, UK Reporting to: Scientist II, Global Technical Development Job Summary Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the life of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cell (HSC). Orchard has its global headquarters in London and U.S. headquarters in Boston.Global Technical Development sits within Technical Operations at Orchard and is responsible for the development and characterization of Lentiviral Vectors (LVVs) and Drug Substance/Drug Product production processes, which meet patient demand for therapeutic products of the best quality.Reporting to Scientist II, Global Technical Development, the Scientist will be involved in activities for development of ex-vivo gene therapy manufacturing processes along the development pathway to the point of process qualification.  They would be a key part of the cell process development function supporting both early- and late-stage development to achieve the key project goals.This position is primarily based in Orchard's state-of-the-art Hammersmith labs and will require being onsite 3+ days a week.Key Elements and Responsibilities · Design and implement improvements in processes and characterize gene modified HSC-based processes and products to deliver robust processes for early and late-stage clinical development. · Design and perform experiments and data analysis in Orchard's Hammersmith labs, and prepare high quality data presentations, reports and standard operating procedures.· Presentation of development data to the wider department and functional teams, and discuss/suggest conclusions, impact and next steps.  · Assist with lab management duties, stock management and equipment maintenance.· Preparation and review of documents, including risk assessments, development protocols and reports, and SOPs.· Assist with experimental design and oversight of development at company designated Contract Development and Manufacturing Organizations (CDMOs). · Participate in multi-disciplinary teams to perform risk-based analysis of processes where appropriate and providing impact assessments as required.· Support validation requirements pre PPQ, in accordance with current industry standards, CMC regulatory standards and best practices in the evolving field of cell and gene therapy.· Other activities as may be assigned. RequirementsRequired Knowledge & ExperienceAs a proven technical scientist with applied experience in the development, manufacture and delivery of cell-based therapy products and/or biotechnology industry, this candidate will possess: · Experience in the biotechnology or pharma industry e.g. >3 years' experience (depending on scope and relevance), with a primary focus on biotechnology/biological sciences, ideally the development, manufacture, distribution and delivery of cell and gene therapy products· Expertise of gene therapy vectors and autologous gene modified cellular therapies, and associated analytical methods· Technical experience including the development, integration and implementation of equipment and processes for clinical and/or commercial application.· Capable of independently designing and conducting experiments, analysing data and effectively managing their time· Understanding of tech transfer, GMP manufacture, and process development · Experience or understanding of regulatory filings a plus· DOE and QBD experience a plus Skills and Abilities · Excellent interpersonal skills· Excellent written and oral communication skills· Outstanding organizational skills · Creative problem solver · Ability to operate in a fast-paced, multi-disciplinary industrial environment · Experience authoring development reports preferredEducation · BSc, MSc or PhD or equivalent, in bioprocessing, biological sciences, gene therapy or related subject