Location: London, UK (Laboratory based- role)
Reporting to: Principal Scientist, Global Technical Development
Job Summary
Reporting to the Principal Scientist, Global Technical Development, the Associate Scientist will contribute towards laboratory-based activities supporting lentiviral vector (LVV) process development. Under supervision, the Associate Scientist will execute 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. Assist in lentiviral vector (LLV) laboratory activities including preparation of materials (e.g. buffers and reagents), consumables and equipment for development studies and/or analysis.
2. Support execution of upstream process (USP) (e.g. cell expansion in shake flasks and bioreactor(s), transfection, enhancement and nuclease treatment) and/or downstream process (DSP) (e.g. harvest/clarification, tangential flow filtration, chromatography and sterile filtration) experimentation under supervision.
3. Assist in analysis of LVV samples generated, data compilation within relevant databases and data checking for integrity.
4. Support authoring or data checking of development protocols and reports ensuring documentation quality is suitable for internal use and regulatory submission with appropriate review.
Lab maintenance
1. Contribute to vector laboratory upkeep, including routine laboratory and equipment maintenance, material ordering and inventory management, in line with safety and quality standards.
2. Support in authoring or review of standard operating procedures and/or risk assessments for vector equipment as and when required.
Broader Technical Development & CMC Exposure
1. Potentially participate in CMC vector sub-team and cross-functional activities particularly where development activities are conducted in-house.
2. May be required to support CMC activities including compilation of data from batch records, generation of source documents and/or conducting DI checks.
3. Other activities may be assigned.
Requirements
Required Knowledge
· Experience in biotechnology/biological sciences or equivalent. Experience in cell and gene therapy is highly desirable.
· Understanding of vector manufacturing process operations including cell culture (adherent and/or suspension platforms), filtration, chromatography and tangential flow filtration operations. Practical experience in at least 2 of the above process steps is required.
· Understanding of analytical methods associated with gene therapy vectors and /or autologous gene-modified cellular therapies. Practical experience in vector analytics is highly desirable.
· Confident in performing various laboratory techniques, especially in aseptic culturing, with the ability to quickly learn and develop new practical skills.
Skills and Abilities
· Excellent interpersonal skills
· Outstanding organizational skills
· Excellent written and oral communication skills
· Creative problem solver
· Ability to operate in a fast-paced, multi-disciplinary industrial environment
Education
· A minimum of BSc or equivalent in bioprocessing, biological sciences, gene therapy or related subject.