Scientist I, Global Technical Development (Hiring Immediately) in London

Location: London, UK (Laboratory based role)

Reporting to: Principal Scientist, Global Technical Development

Job Summary

Reporting to the Principal Scientist, Global Technical Development, the Scientist I will independently perform laboratory-based activities supporting lentiviral vector (LVV) process development. The role involves execution of upstream and downstream process studies, vector analytics, and generation of high-quality technical documentation, while collaborating with cross-functional teams to support development, technology transfer, and CMC deliverables across the programmes.

Key Elements and Responsibilities

• Perform analysis of LVV samples generated from assigned studies. Ensure that experimental results are maintained in relevant databases.
• Design and execute experiments with guidance where required, including data analysis and interpretation. Present experimental results and development updates to the wider department or functional teams as requested.
• Lab maintenance.
• Author and review standard operating procedures (SOPs) for vector-related equipment and processes and contribute to risk assessments as required.
• Contribute to vector laboratory upkeep, including routine laboratory and equipment maintenance, material ordering and inventory management, in line with safety and quality standards.
• Contribute to capability-building initiatives, including development and application of scale-down models for suspension LVV processes, supporting process understanding and optimization at larger scale.
• Support process characterization and validation activities ahead of PPQ, in alignment with current industry standards, CMC regulatory expectations and best practices in cell and gene therapy.
• Involved in development, integration and implementation of (new) vector processes either at OTL labs or at external partners (e.g. CDMOs). This may include technology transfer initiatives between laboratories.
• Potentially participate in early-phase CMC program team activities, including cross-functional collaboration, to support completion of key project goals.
• Support CMC activities as required, including generation of source documents and/or conducting data integrity (DI) checks.
• Collaborate with process research, pre-clinical, QA, MSAT and other departments to support delivery of project timelines and milestones.
• Other duties as assigned.

Requirements

• Expected approximately 2 to 5 years’ experience depending on scope and relevance, in biotechnology/biological sciences, with a primary focus on cell and gene therapy.
• Experience in Upstream Process (USP) operations for vector production for adherent and/or suspension cell-based platforms. Hands-on experience with suspension bioreactors is highly desirable.
• Experience in Downstream Process (DSP) operations including clarification/filtration, chromatography, tangential flow filtration and sterile steps. Practical/hands-on experience with DSP processes is highly desirable.
• Understanding of analytical methods associated with gene therapy vectors and/or autologous gene-modified cellular therapies. Practical experience in vector analytics is highly desirable.
• Basic understanding of regulatory filings and associated reports/sections writing and knowledge of FDA, EMA, GMP and ICH regulatory requirements.