Scientist I, Global Technical Development

Location: London, UK (Laboratory based role)

Reporting to: Principal Scientist, Global Technical Development

Job Summary

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

• Core Activities
  • Independently perform assigned laboratory activities for lentiviral vector (LVV) manufacturing process, including upstream process (USP) operations and/or downstream process (DSP) operations.
  • 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.
  • Author, review and data-check development protocols and technical reports, ensuring documentation quality is suitable for internal use and regulatory submission.
• 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.
• Broader Technical Development & CMC Exposure
  • Contribute to capability-building initiatives, including development and application of scale-down models for suspension LVV processes.
  • 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.
  • 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.

Required Knowledge

• Approximately 2 to 5 years’ experience 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.
• Understanding of analytical methods associated with gene therapy vectors and/or autologous gene-modified cellular therapies.
• Capable of independently designing and/or conducting experiments, analyzing data and effectively managing their time.
• Basic understanding of regulatory filings and associated reports/sections writing and knowledge of FDA, EMA, GMP and ICH regulatory requirements a plus.
• DOE, QBD and Benchling experience a plus.

Skills and Abilities

• Excellent interpersonal skills
• Positive can-do attitude
• Outstanding organizational skills
• Excellent written and oral communication skills
• Creative problem solver
• Ability to operate in a fast-paced, multi-disciplinary industrial environment
• Experience authoring development reports preferred

Education

• BSc, MSc or PhD in bioprocessing, biological sciences, gene therapy or related subject.