Senior Scientist II, PD Vector - Upstream

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Senior Scientist II, PD Vector - Upstream, London

Client:

Location: London, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 21b5ce74cd8b

Job Views: 13

Posted: 28.04.2025

Expiry Date: 12.06.2025

Job Description:

Role Summary

The post holder will be highly motivated and organised with knowledge of gene and cell therapy, process development, and biotechnology. The individual will be expected to lead a team within the function. Required technical skills include proven skills with viral vector or vaccine upstream production systems, including multi-layer culture systems and bioreactors platforms, preferably adherent cell culture. Additionally, knowledge and experience with associated analytical methods such as Cell Based Assays, Flow Cytometry, ELISA are required. This role involves close collaboration with other departments and team members and contributing to the development of processes suitable for cGMP manufacture of high-quality therapeutic products.

Key responsibilities

1. Contribute to the strategy design and development for viral vector manufacturing projects.
2. Collaborate with different departments within the company to develop viral vector process strategies.
3. Act as the subject matter expert for viral vector process aspects in cross-functional projects.
4. Co-author the CMC section of regulatory submissions supporting INDs and BLAs.
5. Participate in evaluating novel technologies and automation for GMP clinical production.
6. Develop processes suitable for manufacturing viral vectors.
7. Design and perform experiments to characterize and optimize critical process parameters.
8. Perform Design of Experiments (DoE) and analyze data for viral vector purification.
9. Develop and implement process and product improvements through experiments.
10. Author development and technology transfer reports, SOPs, review BMRs, and regulatory documents.
11. Lead technology transfer to manufacturing.
12. Participate in meetings, sharing results clearly and logically.
13. Support instrument maintenance, calibration, and lab housekeeping.
14. Work independently with external service providers.
15. Perform other duties as required in consultation with the post holder.
16. Adhere to all health and safety guidelines provided by the company.