Orchard Therapeutics

Location: London, UK Reporting to: Vice President, Global Manufacturing Technology & Supply Job Summary The Associate Director, Global Supply Planning is responsible for end-to-end (E2E) supply planning activities for Orchard s cell and gene therapy supply chain managing GMP plasmids, Vector Products (VP) and Drug Products (DP). This includes manufacturing planning at Orchard's Contract Development and Manufacturing Organisations (CDMO's) and ongoing management and control of Orchard's GMP Inventory for Clinical and Commercial Operations. The job holder is part of the Global Manufacturing Technology & Supply leadership team, and will be expected to provide thought leadership on best supply planning practices supporting the overall Tech Ops strategic objectives. Key Elements and Responsibilities Supply Planning Lead the Supply Planning process within Technical Operations for all programs and channel to operations addressing demand from Clinical, Medical and Commercial Lead a cross functional Demand Planning Process Generate supply and inventory planning across all of Orchard's supply network and time horizons. Inventory and Master Data Management Develop the Material Requirements Planning (MRP) strategy, Proactively manage obsolete inventory within the CDMO and 3rd party logistics (3PL) network Manage 3rd party cold storage providers Ensure master data accuracy Lead the creation of inventory and storage policies in line with the latest GMP regulations. Own and manage existing ERP system and support any future implementation of enterprise systems such as ERP and/or Advanced Planning Systems. Manufacturing Planning and Execution Ensure sufficient supplies of Clinical and Commercial Vector Product (VP) and capacity for Drug Product (DP) manufacturing Manage CDMO GMP Supply Ordering and Delivery for Plasmids, VP and DP Oversee the administration of all CDMO manufacturing financial transactions. KPIs and Process Improvements Define, monitor and strive to improve Key Performance Indicators to create a continuous improvement culture and collaborative planning environment Identify and implement key supply chain related initiatives with internal stakeholders and external partners to improve supply chain efficiency. Required Knowledge At least 12 years of end-to-end supply chain experience with a minimum of 5 years of relevant biotechnology or pharmaceutical industry in roles across supply chain planning operations and external manufacturing in a global matrix Relevant experience in cell & gene therapy and autologous ex-vivo gene therapy is ideal Strong track record of effective team leadership, preferably in global organisations. Proven experience in Demand/Supply Planning and Sales & Operations Experienced in developing, implementing, and leading strategic initiatives which deliver change, continuous improvement and Operational Excellence to the business Experience in managing and implementing supply chain systems across multiple areas of supply chain such as traditional ERP and SaaS technology Strong Working knowledge of regulatory frameworks (FDA, EMA etc) GMP manufacturing and GMP storage requirements Proven collaborative planning and relationship management experience in the biologics contract manufacturing or similar industry. Skills & Abilities Action-oriented and resourceful Highly influential individual, able to navigate a complex landscape of stakeholders at all levels Builds trusted partnerships and works collaboratively to meet shared objectives Team-player as well as a highly supportive team lead with a continuous improvement coaching style and lead by example mentality Resilient, works well under pressure and is able to prioritise and make robust decisions Plans and prioritizing work to meet commitments aligned with organizational goals Proven track record of achieving results. Education Minimum of bachelor's degree in supply chain management, Life Sciences, Business Management or Engineering with relevant qualifications and experience in Supply Chain Operations and/or Operational Business Planning.

Location: London Reporting to: Associate Director, MSAT (Cell Process) Job Summary The successful candidate will be providing maternity cover for 12 months fixed term with responsibility for overseeing characterization and validation activities to support transition of validated assets from Technical Development to MSAT and ensure readiness of late phase programs for commercialization along with overseeing GMP manufacture at CDMO. The individual will have relevant experience in Cell Gene therapy products, GMP manufacture particularly in cell therapies. The post-holder will be a key member of the MSAT team and provide phase appropriate management of cell DS DP processes in-line with program and company plans and will work collaboratively with both internal and external stakeholders to ensure timely and robust implementation of appropriate product quality attribute strategies as well as represent Orchard in regulatory inspections and discussions. Key Elements and Responsibilities Support clinical GMP production and testing of Drug Substance (DS) and Drug product (DP) product at CDMOs including but not limited to review and approval of master & executed batch records, test records and associated documentation for DP manufacture & release. Provide expert compilation, review, editing and approval of relevant documentation including but not limited to master production records, standard operating procedures, development/validation protocols and reports & quality documentation. Support technology transfer of PPQ-DS/DP process manufacture to GMP or throughout GMP facilities as required. Collect, assemble, analyze and summarize production data from early-stage trials using appropriate statistical methods and ensure phase appropriate monitoring of DP manufacturing data to support process control parameters and specifications and participate in OOS and OOT investigations according to internal SOPs Oversee the development of early-stage control strategy and defining process characterization studies during clinical manufacture up to PPQ and lead post PPQ activities and product management. Maintain a high Quality standard by complying with all SOPs related to GxP, trainings, data integrity, participation in quality investigations and ensuring timely resolution of all manufacturing quality events . Establish process validation procedures and templates to standardize approaches to preparation, execution and reporting of activities. Oversee development validation activities and ensure requirements pre PPQ, in accordance with current industry standards, CMC regulatory standards and best practices in the evolving field of cell and gene therapy. Lead & participate in multi-disciplinary teams to perform risk-based analysis of processes where appropriate and providing impact assessments as required. Assess the impact of process changes on validation status and support change implementation. Author/ review of technical documents and relevant sections related to Health Authority submissions. Participate in relevant internal and external meetings as required and communicate complex information to various audiences. Travel as required to provide on-site support oversight during key DS/DP manufacturing activities & provide support to CDMOs. Required knowledge Understanding of the Product Life Cycle, with reference to industry standards and guidelines Experience with risk-based approaches, such as Failure Modes and Effects Analysis Experience with manufacturing or process development within the pharmaceutical or biopharma industry, preferably in vector, cell and gene therapy. Experience within a Process Validation role. Experience and understanding of technology transfer. Experience within other aspects of Process Validation. Experience in GMP manufacture, process development and process characterization Skills & Abilities Demonstrated skills and capability in planning, preparing, executing and reporting of process validation activities Ability to evaluate and interpret development and manufacturing data Knowledge of statistical data analysis Attention to detail Working across cross functional teams to direct validation activities and drive results Ability to visualize / present data to clearly communicate ideas, concepts and results to technical and non-technical audiences Interest in continuous improvement of processes Organization and time management to deliver results Knowledge of vector and cell therapy processes, or with Biologics processes would be advantageous. Education Degree or equivalent higher education qualifications in a relevant science or engineering discipline. Extensive experience in the biopharmaceutical industry leading process validation activities or process development

Reporting to: Director of Advanced Analytics, Technical Development Location: London 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. The Technical Development (TD) organisation at Orchard is responsible for the development of manufacturing and analytical processes of Orchard's HSC-based gene therapy pipeline which is actively collaborating with internal stakeholders and external CDMOs to develop innovative technical solutions to bridge early-stage, late-stage and commercial product needs. The Principal Scientist, Analytical Development will be primarily responsible for delivering late stage analytical project milestones of specified Orchard development programs in close partnership with technical and regulatory functions within Orchard and at CDMOs. They will also be a member of the CMC team representing Analytics for the assigned project(s). The incumbent will work together with innovator partners in process development as an integrated part of the development programs to provide scientific, technical support for advancing, de-risking and accelerating all stages of product development, including candidate selection. The ideal candidate has demonstrated leadership and knowledge of the development, validation design and execution, implementation, maintenance and improvement of analytical methods as well as the delivery of high-quality regulatory submissions. Responsibilities Implement defined project analytical strategy for the assigned Orchard's late- stage development programs in close partnership with technical and regulatory functions at Orchard and CDMOs. Design analytical method validation strategies for Orchard's programs in support of regulatory filings enabling strong analytical packages and robust control strategies ensuring product quality and compliance with applicable ICH guidelines and global health authority requirements and expectations. Lead the development of breakthrough analytical techniques aiming at achieving enhanced characterization, elucidate safety profile of gene therapies at cellular level and achieve advanced control over manufacturing consistency (e.g., first-in-class rapid assays, single cell analytics). Source, manage, and analyze large amounts of unstructured data via quantitative algorithms and statistical tools to address technical questions and drive program strategies. Serve as a subject matter expert, author and/or review relevant sections of CMC documentation in support of regulatory submissions, amendments as well as interactions with regulatory authorities. Proactively engage in collaboration with internal organisations (e.g. Research, Clinical Development and Operations, Quality, Manufacturing) and external stakeholders (e.g. CDMOs, contract testing labs) including health authorities and industry trade organizations to identify trends and expectations and incorporate them into Orchard's analytical development and control strategies. Actively support inspection readiness activities and associated Health Authority Inspections; ensure quality, regulatory and EHS compliance. Qualify, validate and transfer analytical methods to ensure product quality and compliance with applicable ICH guidelines and FDA/EMA and other global health authority requirements and expectations; and provide technical input into selecting the most appropriate methodology, assay development and design. Support drug product characterization analysis and establishment of cellular gene therapy product CQA and markers that predict clinical efficacy and safety. Provide input into science-based, phase appropriate, and risk-based analytical validation strategy and specification setting to support clinical programs from pivotal phase to commercial registration and managed analytical assays for commercial products. Support the authoring and reviews of quality reports and documentation related to development, characterization and testing of analytical methods, as well as relevant sections of CMC documentation in support of regulatory submissions, dossier amendments as well as interactions with regulatory authorities. Required knowledge 7 years' experience in analytical development in the pharmaceutical industry Deep understanding of analytic techniques with a strong knowledge of the development, validation, implementation, analytical methods as well as the delivery of high-quality regulatory submissions Sophisticated knowledge and experience onstatistics-driven approaches and tools to quality and processunderstandingin thepharmaceuticalindustry Experience in late phase development of Cell and gene therapy, lentiviral vectors, hematopoietic stem cell biology and characterization and/or in vaccines/biologics characterization. Strong working knowledge and interpretation of FDA/EU and ICH regulations and guidelines. Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections Skills & Abilities Demonstrated technical proficiency, scientific creativity, business acumen, collaboration with others, independent thought and learning agility Able to deliver high quality regulatory submissions Effective communicator and influencer with proven ability to build relationships internally and externally to the organization that enable strong collaboration between all key stakeholders to achieve critical milestones Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines Excellent problem-solving skills and organizational skills Seeks and analyzes data from a variety of sources to support decisions and align others Comfortable with ambiguity and uncertainty; able to make decisions through complex situations Creates collaborative and trusting relationships internally and with external partners Education Ph.D. in Biotechnologies, Life Sciences, or related field with strong expertise in advanced analytics and data science applied to the development of cell and gene therapies

Location : London (Hammersmith) Reporting to :Director, Viral Vector Development 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. Technical Development sits within Technical Operations at Orchard and is responsible for the development and characterization of Lentiviral Vectors (LVVs) and DS/DP production processes, which meet patient demand for therapeutic products of the best quality. Reporting to the Director, Viral Vector Development, the Principal Scientist, Viral Vector Development, will be responsible for the development of innovative, high-yield processes for production of LVVs for the defined project(s). The candidate will closely interact with other functional groups including analytics, cell process development, CMC and regulatory teams. This role is based in our Hammersmith, London facilities within our global headquarters and will suit candidates who would like to join a global company with a diverse and dynamic work environment that provides opportunities for sustained personal and professional growth. Key Elements and Responsibilities Design, develop and improve upstream and downstream processes for LVVs to deliver robust manufacturing platforms for early and late-stage clinical and commercial development Execute experimental plans, analyse experimental data and write technical reports Provide hands-on technical expertise/scientific guidance to team members and supervision of junior colleagues Contribute to the transfer of improved processes to GMP and assist with oversight of manufacturing activities as required Assist in the reporting, investigation and resolution of deviations encountered during GMP production activities Prepare, review and complete protocols/SOPs, study reports and assist with regulatory submissions Communicate, share and discuss work progress internally and externally Perform landscape scouting to drive continuous improvement in quality, yield and COGs Provide expert review and approval of executed batch, records, test records and associated documentation for release of LVVs and plasmids used in their production. Experience & Knowledge In-depth knowledge of state-of-the-art cell & gene therapy products and available technologies, more specifically regarding viral vectors Minimum of 5 years of experience with development, manufacture and delivery of viral vectors, preferably retro and lentiviral vectors including late phase product development Experience with risk-based approaches, such as Failure Modes and Effects Analysis Demonstrated skills and experience in adherent and suspension cell lines in different culture systems Demonstrated knowledge in designing and developing processes for LVV production and purification Experience in process characterization and validation of the large-scale cGMP production of lentiviral vectors Experience with specialised lab equipment e.g. bioreactors, AKTA, TFF systems, etc Proficiency with MS office, MFCS, SnapGene, Unicorn, e-lab books and other commonly used software is required. Experience with DoE software (s) and statistical analysis would be ideal. Knowledge of FDA, EMA, GMP and ICH regulatory requirements Knowledge of Quality Systems and QBD as they relate to GMP production operations, process optimization and process validation. Knowledge of statistical data analysis Knowledge of plasmid DNA manufacturing would be an asset. Skills and Abilities Demonstrated skills and capability in planning, preparing, executing and reporting of process development and validation activities. Ability to operate in a fast paced, multidisciplinary industrial environment Creativeness, motivation, and troubleshooting skills to solve problems and/or develop new technical capabilities Excellent interpersonal and communication skills Ability to visualize / present data in order to communicate ideas, concepts and results to technical and non-technical audiences. Ability to independently design and appropriately analyse data and provide an interpretation of results Strong organization and planning skills to prioritise work and meet deadlines Education PhD, BSc or equivalent in biotechnology, process development, cell and gene therapy, biological sciences, or other relevant scientific disc

Location: Boston, MA or London, UK Reporting to: Vice President, Global Medical Affairs and Diagnostics Job summary Reporting to the Head of Global Medical Affairs, the Senior Medical Director of Global Medical Affairs position will lead development of global medical strategies for Orchard's late stage hematopoietic stem cell gene therapy (HSC-GT) programs including approved products. The Senior Medical Director works in partnership with Regional Medical Affairs teams to ensure alignment and pull-through of global medical strategies for supported programs. This role ensures medical affairs representation on cross-functional program teams and contributes to the development of integrated program strategies. This individual will be the global medical lead for at least one program and also manages a team of direct reports that cover individual programs worldwide. Key Elements and Responsibilities Responsible for the development and implementation of the Medical Affairs global strategic plans and evidence generation plans for Orchard's late stage programs in metachromatic leukodystrophy and Wiskott-Aldrich syndrome, Serves as global medical affairs lead for at least one of the above programs while overseeing team of direct reports that hold responsibilities for additional programs Partners with Regional Medical Affairs, Diagnostics, Clinical Sciences, Biostatistics, and Medical Communications functions in the execution of the medical strategy Internal and external subject matter expert on HSC-GT including providing training and serving as internal consultant on cross-functional projects Oversee global medical training of qualified commercial treatment centers (QTCs) for approved therapies Oversee review of compassionate use requests and collaborate with cross-functional teams to enable compassionate use treatment Provide expertise as a member of internal team approving grants and research proposals Collaborate cross functionally with commercial and other stakeholders to plan launch activities for the programs lined up for file/approval Collaborate with the commercial team on market access, reimbursement plans Support regional teams in building KOL physician relationships and representing the company in key meetings, congresses Support patient advocacy team in building relationships with patient advocacy groups working in relevant therapeutic areas and providing disease and product education Working in partnership with the cross functional study team, develop phase 4 clinical studies/programs/registries ensuring the development, review, finalization and delivery of scientifically and operationally robust study documents in order to meet study timelines Collaborate with CMC/Manufacturing to help assess needs/activities for commercialization Other responsibilities as assigned Travel 25-40% Qualifications/Requirements MD, PhD or PharmD with extensive experience in HSC-GT 5+ years experience in Medical Affairs at regional or global level Experience managing direct reports is preferred Gene therapy background preferable Biotech background preferable Experience in Leading a complex Matrix team Robust understanding clinical development and drug commercialization Commercial/reimbursement experience ideal in rare diseases Fluency in English required Skills and Abilities Experienced individual, capable to work independently and make decisions/ recommendations to a board/ management team Accountable and responsible individual Collaborative working syle; the ideal candidate will partner effectively with his colleagues across the organization to seek critical information, constructively challenge plans and assist with the optimal allocation of resource Strategic mindest Excellent organisational skills; the ideal candidate will be able to prioritize activities depending on business imperative and to contibute to several projects in parallel Outstanding presentation skills 'Can-do' attitude, excellent problem solving skills, solutions focussed and strong team player. Able to work in a virtual enterprise Able to manage complex data Able to work in a pressurized environment Able to manage/collaborate with a group of world leader experts Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications. We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment. Notice to All Applicants: Orchard Therapeutics participates in E-Verify RECRUITERS All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.