Principal Scientist, Viral Vector Development

Location: London (Hammersmith)

Reporting to: Director, Viral Vector Development

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the life of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cell (HSC). Orchard has its global headquarters in London and U.S. headquarters in Boston.

Technical Development sits within Technical Operations at Orchard and is responsible for the development and characterization of Lentiviral Vectors (LVVs) and DS/DP production processes, which meet patient demand for therapeutic products of the best quality.

Reporting to the Director, Viral Vector Development, the Principal Scientist, Viral Vector Development, will be responsible for the development of innovative, high-yield processes for production of LVVs for the defined project(s).  The candidate will closely interact with other functional groups including analytics, cell process development, CMC and regulatory teams. This role is based in our Hammersmith, London facilities within our global headquarters and will suit candidates who would like to join a global company with a diverse and dynamic work environment that provides opportunities for sustained personal and professional growth.

 Key Elements and Responsibilities

• Design, develop and improve upstream and downstream processes for LVVs to deliver robust manufacturing platforms for early and late-stage clinical and commercial development
• Execute experimental plans, analyse experimental data and write technical reports
• Provide hands-on technical expertise/scientific guidance to team members and supervision of junior colleagues
• Contribute to the transfer of improved processes to GMP and assist with oversight of manufacturing activities as required
• Assist in the reporting, investigation and resolution of deviations encountered during GMP production activities
• Prepare, review and complete protocols/SOPs, study reports and assist with regulatory submissions
• Communicate, share and discuss work progress internally and externally
• Perform landscape scouting to drive continuous improvement in quality, yield and COGs
• Provide expert review and approval of executed batch, records, test records and associated documentation for release of LVVs and plasmids used in their production.

Experience & Knowledge

• In-depth knowledge of state-of-the-art cell & gene therapy products and available technologies, more specifically regarding viral vectors
• Minimum of 5 years of experience with development, manufacture and delivery of viral vectors, preferably retro and lentiviral vectors including late phase product development
• Experience with risk-based approaches, such as Failure Modes and Effects Analysis
• Demonstrated skills and experience in adherent and suspension cell lines in different culture systems
• Demonstrated knowledge in designing and developing processes for LVV production and purification
• Experience in process characterization and validation of the large-scale cGMP production of lentiviral vectors
• Experience with specialised lab equipment e.g. bioreactors, AKTA, TFF systems, etc
• Proficiency with MS office, MFCS, SnapGene, Unicorn, e-lab books and other commonly used software is required. Experience with DoE software (s) and statistical analysis would be ideal.
• Knowledge of FDA, EMA, GMP and ICH regulatory requirements
• Knowledge of Quality Systems and QBD as they relate to GMP production operations, process optimization and process validation.
• Knowledge of statistical data analysis
• Knowledge of plasmid DNA manufacturing would be an asset.

Skills and Abilities

• Demonstrated skills and capability in planning, preparing, executing and reporting of process development and validation activities.
• Ability to operate in a fast paced, multidisciplinary industrial environment
• Creativeness, motivation, and troubleshooting skills to solve problems and/or develop new technical capabilities
• Excellent interpersonal and communication skills
• Ability to visualize / present data in order to communicate ideas, concepts and results to technical and non-technical audiences.
• Ability to independently design and appropriately analyse data and provide an interpretation of results
• Strong organization and planning skills to prioritise work and meet deadlines

Education

PhD, BSc or equivalent in biotechnology, process development, cell and gene therapy, biological sciences, or other relevant scientific disc