Senior Scientist (Laboratory Data Systems), Global Technical Development in London

Location: London, UK (Laboratory based role)

Reporting to: Principal Scientist, Global Technical Development

Job Summary

As part of laboratory expansion initiatives, we are looking for an ELN Administrator & Data Scientist to lead our lab digitalisation and data management efforts. The Senior Scientist will be responsible for laboratory data systems across multiple laboratories.

In this role, the candidate is responsible for ensuring that the ELN platform is optimized for daily laboratory operations as well as to build data infrastructure to support data driven scientific innovation and/or decision making. The ideal candidate will possess a diverse skill set that encompasses technical expertise, domain-specific knowledge, and strong soft skills to partner effectively with R&D Scientists, Quality and IT stakeholders in driving impactful data solutions.

Key Elements and Responsibilities

• ELN Administrator responsibilities

• Collaborate with key stakeholders in Research and Development (R&D) Laboratories, Quality and IT to understand business requirements and objectives for the ELN platform.
• Analyse current business processes and workflows to identify opportunities for improvement and automation through the use of technology.
• Collaborate with R&D scientists and stakeholders to understand scientific user and functional requirements to translate to the configuration of ELN.
• Configure ELN standard modules, including Inventory, Registry, and Workflows, to support sample tracking and laboratory processes.
• Design and implement integrations between ELN and other systems using APIs and integration frameworks, and creation of specific processes to ensure seamless and compliant data integrity.
• Develop custom workflows to enhance the functionality of the ELN platform, with appropriate development testing & troubleshooting.
• Develop dashboards and custom label reports for monitoring of R&D data.
• Monitor and troubleshoot any issues that arise, ensuring the smooth operation of the ELN platform.
• Draft technical documentation to support and deliver ELN training for onboarding and periodic training review/updates.
• Provision of primary day-to-day support and training on ELN for all R&D Scientists.
• Implement routine monitoring of practices to ensure data integrity and tracking compliance with internal ELN policies.
• Primary point of contact and liaison with ELN support and customer success services.
• Serve as Orchard liaison for ELN interactions with broader Kyowa Kirin Group.

• Lead development and implementation of a centralised Technical Development data repository, involving assessments of data sources and types generated through program lifecycle, including from CDMOs and seamless data integration into an internal data management system.
• Develop methodology and infrastructure to manage collation, review and extraction of multi-source datasets, streamlining data-driven decision making and reducing manual data handling.
• In collaboration with Quality and MSAT, ensure that Technical Development data repository meets data integrity requirements for use in CMC (Chemistry, Manufacturing, and Controls) dossiers and regulatory filings.
• Facilitate alignment on data capture methods and long term analytical goals between Technical Development, MSAT, Quality and IT.
• Provide specialist support across all teams in the adoption of advanced statistical methods, data mining/modelling, and Design of Experiments (DoE) to embed Quality by Design (QbD) principles across product development lifecycle.
• Support introduction of Laboratory Information Management System (LIMS) as part of laboratory expansion initiatives.

Qualifications / Required Knowledge

• Bachelor's degree in Data Science, Bioinformatics, Statistics, Biological Sciences, Engineering or a related field.
• At least 3 years of experience working in a scientific laboratory environment (academia, biotech or pharma) with hands-on experience in ELN administration and Data Sciences.
• Proven ability to configure schemas, develop custom workflows and optimise platform utilisation. Prior experience in use of Benchling ELN is preferred.
• Knowledge/understanding of the Cell and Gene Therapy Industry is desirable.
• Experienced in statistical modelling, DOE, multivariate data analysis and process analytics including applications e.g. JMP.
• Strong programming skills in languages such as Python, JavaScript, or Java; experience with SQL preferred.
• Experience in laboratory informatics or other data management tools.
• Understanding of regulatory standards including GxP, ALCOA+ principles, and 21 CFR 11 requirements.

Skills and Abilities

• Excellent analytical and problem-solving skills.
• Excellent interpersonal skills in communication and collaboration.
• Ability to work independently and as part of a team.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment; proven track record delivering under tight timelines.