Location: London, UK (Hybrid role)

Reporting to: Principal Scientist, Global Technical Development

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative cell and gene therapies. Orchard has its global headquarters in London and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

Job Summary

The ELN and data specialist will act as the organisation's subject-matter expert for our ELN platform, responsible for its configuration, governance and continuous improvement across our R&D laboratories. As the primary point of accountability for the ELN platform, the Senior Scientist will define the standards and best practices for its use and guide scientists and superusers in applying them. While accountable for the platform across R&D, the role will be primarily focused on enabling Technical Development (TD) activities, while also supporting research activities.

The role entails the hands-on administration, configuration and ongoing development of the ELN platform to support laboratory operations and good data management practice, alongside extending its capability to support broader laboratory data and analytics activities. A key responsibility will be coordinating and collating the requirements of all users and ensuring that suitable ELN tools are developed that are fit for purpose. The role is also responsible for building and maintaining data repositories within TD to support data-driven scientific innovation and decision making.

The ideal candidate combines hands-on ELN and laboratory experience with sound scientific understanding and interpersonal skills to partner effectively with R&D, Quality and laboratory informatics teams.

Key Elements and Responsibilities

ELN Design and Development

·         Own the continuous improvement of the ELN platform, identifying and prioritising enhancements in line with evolving laboratory and data needs.

·         Engage stakeholders across R&D laboratories, quality and lab informatics to capture and define their requirements for the ELN platform.

·         Design and build the ELN tools required, including standard modules (e.g. Inventory and Registry), workflows and templates to support laboratory operations.

·         Support the design and implementation of integrations between the ELN and other laboratory or business systems.

·         Support the development of dashboards and custom label reports for monitoring of R&D data.

·         Evaluate and trial new ELN features, such as in-built AI capabilities, to drive continuous improvement.

ELN Operations and Support

• Monitor and troubleshoot any issues that arise, ensuring the smooth operation of the ELN platform.
• Write technical documentation to support ELN usage.
• Deliver ELN training as required.
• Provide day-to-day support and technical guidance to the ELN superusers.
• Establish, implement and monitor the practices and standards that uphold data integrity and ensure compliance with internal ELN policies.
• Act as R&D's representative and primary liaison for the ELN, with internal project teams, the broader Kyowa Kirin organisation and external parties such as the ELN vendor.

Data Management

·         Act as the primary liaison between TD and the consultants (data engineers), translating scientific data requirements into clear specifications for the design and delivery of a data repository.

·         Lead the development and implementation of a centralised TD data repository that consolidates data from across the programme lifecycle (including CDMOs) and meets the data integrity requirements for CMC dossiers and regulatory filings.

·         Collaborate across TD, Manufacturing Science and Technology, Quality and laboratory informatics to align on consistent data capture methods, data structures, nomenclature and shared data goals.

·         Define the reporting and analytics needs required to enable data-driven scientific decision-making from the repository.

·         Write SQL queries to extract, transform and validate data from laboratory systems and the data repository.

Qualifications & Experience

Required:

·         Bachelor's degree in Data Science, Biological Sciences, Engineering or a related field.

·         Proven experience working in a scientific laboratory environment (academia, biotech or pharma) including substantial hands-on experience in ELN administration.

·         Understanding of process development and manufacturing.

·         Proven ability to configure and customise an ELN (Benchling preferable) or comparable laboratory informatics platform, including schemas, modules and custom workflows.

·         Understanding of regulatory standards including GxP, ALCOA+ principles, and 21 CFR Part 11 requirements.

Desirable:

·         Knowledge and understanding of the cell and gene therapy industry.

·         Experience designing and implementing system integrations using APIs and integration frameworks.

·         Experience with statistical modelling, DoE, multivariate data analysis and process analytics, including applications such as JMP.

·         Proficiency in programming skills in languages such as Python.

Skills and Abilities

·         Excellent analytical and problem-solving skills, with sound judgement in balancing user needs, compliance and practicality.

·         Strong collaboration, communication and stakeholder-management skills, able to translate between scientific, quality and lab informatics audiences and to build consensus.

·         Able to work independently, take ownership and prioritise across competing demands in a multidisciplinary environment.

·         Ability to operate in a fast-paced, multi-disciplinary industrial environment; proven track record delivering under tight timelines.

Requirements