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About the Role

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. This role will define standards and best practices for ELN use and guide scientists and superusers. The role is primarily focused on enabling Technical Development (TD) activities, while also supporting research activities.

Responsibilities

Own the continuous improvement of the ELN platform, identifying and prioritising enhancements.
Engage stakeholders across R&D laboratories, quality and lab informatics to capture and define their requirements for the ELN platform.
Design and build ELN tools, including standard modules, workflows and templates.
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.
Monitor and troubleshoot ELN platform issues.
Write technical documentation to support ELN usage.
Deliver ELN training as required.
Provide day-to-day support and technical guidance to ELN superusers.
Establish, implement and monitor 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.
Act as the primary liaison between TD and consultants, translating scientific data requirements into clear specifications for data repository design and delivery.
Lead the development and implementation of a centralised TD data repository.
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.

Requirements

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.
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

Excellent analytical and problem-solving skills.
Sound judgement in balancing user needs, compliance and practicality.
Strong collaboration, communication and stakeholder-management skills.
Ability to translate between scientific, quality and lab informatics audiences.
Ability to build consensus.
Ability to work independently.
Ability to take ownership.
Ability to 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.

Location

London, UK

Work Type

Hybrid

Experience Level

Senior Scientist

Education Level

Bachelor's degree

About the Company

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.