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
Core Activities
1. Independently perform assigned laboratory activities for lentiviral vector (LVV) manufacturing process. This may include upstream process (USP) operations (e.g. cell expansion in shake flasks and bioreactor(s), transfection, enhancement and nuclease treatment) and/or downstream process (DSP) operations (e.g. harvest/clarification, tangential flow filtration, chromatography and sterile filtration).
2. Perform analysis of LVV samples generated from assigned studies. Ensure that experimental results are maintained in relevant databases.
3. 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.
4. Author, review and data-check development protocols and technical reports, ensuring documentation quality is suitable for internal use and regulatory submission with appropriate review.
Lab maintenance
1. Author and review standard operating procedures (SOPs) for vector-related equipment and processes and contribute to risk assessments as required.
2. 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
1. 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.
2. 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.
3. 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.
4. 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.
5. Collaborate with process research, pre-clinical, QA, MSAT and other departments to support delivery of project timelines and milestones.
6. Other duties as assigned.
Requirements
Required Knowledge
· 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.
· 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.