Director, Viral Vector Development

About the job

Location: London, UK

Reporting to: Vice President, Global Technical Development

Job Summary

The Director, Lentiviral Vector (LVV) will be responsible for shaping and executing the strategy for suspension-based lentiviral vector (LVV) manufacturing across multiple projects at various stages of development. The successful candidate will lead a high-performing internal LVV team and work in close collaboration with our contract manufacturing organisation (CMO) and internal and external partners to deliver robust, cost-effective, and high-quality viral vector processes.

Key responsibilities include driving process innovation, overseeing GMP production and validation activities, ensuring optimized cost-of-goods (COGs), and enabling scalable production. You will also play a key role in regulatory submission support through expert execution of process validation studies, including DoE-driven investigations and PPQ activities. The role requires a strategic and technically accomplished leader who will ensure the delivery of commercially viable and regulatory-compliant LVV manufacturing solutions.

Key Elements And Responsibilities

• Lead the strategic direction of Orchard’s platform Suspension LVV in collaboration with key external partners across multiple projects at various stages of development.
• Build and manage a high-performing internal LVV team fostering technical expertise and cross-functional collaboration.
• Conduct landscape scouting to identify innovations that drive continuous improvement in quality, yield and COGs.
• Foster a strong collaboration with our key CMOs to ensure alignment, quality, and achievement of mutually defined goals
• Develop and implement a COGS optimized lentiviral process ensuring high quality, and process robustness enabling better patient access to treatment.
• Provide technical leadership and expert oversight during GMP production, testing and fill/finish of lentiviral vectors at CMO’s.
• Establish a robust scale down model for suspension LVV production to ensure process understanding and enable effective optimization at scale production.
• Provide expert support in design and assessment of PPQ activities to ensure high quality commercial ready processes.
• Drive activities for the DoE, protocol generation, execution and reporting of studies to validate production processes and associated assay method controls to support BLA/MAA submissions for company products.
• Serve as person-in-plant during key production campaigns and development/validation activities
• Assist in the reporting, investigation and resolution of deviations encountered during GMP production activities
• Provide expert compilation, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports and associated documentation for release of lentiviral vector lots
• Provide support for creation and expert review of source technical documents and Quality sections of regulatory submissions (IND/CTA/Briefing books).
• Contribute to internal initiatives and support additional activities related to suspension LVV development and manufacturing.

Requirements

Required Knowledge

• The ideal candidate for this position will have demonstrated experience in the development and large-scale cGMP production of lentiviral vectors, including upstream cell culture, downstream processing, and fill finish operations.

Candidate Must Possess

• Minimum of 10 years of experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, downstream processing, and fill finish operations for biologics
• In depth knowledge of lentiviral vector construction and biology
• In-depth experience of the large-scale cGMP production of lentiviral vectors, including
• Upstream cell culture, downstream processing, and fill finish operations
• Process characterization and validation
• Proven track record of managing lentiviral vector development, validation and production both in-house, and at CMO’s/partners
• Demonstrated ability to build and lead technical teams in fast-paced operational environments
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements for biologics and experience in drafting of review of regulatory submissions
• Knowledge of Quality Systems, QBD and PAT as they relate to GMP production operations, process optimization and process validation
• This position requires on site person-in-plant presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite

Skills And Abilities

• A strategic thinker with excellent technical leadership, team building and people leadership skills
• Technical credibility and strong decision-making skills
• Excellent interpersonal skills and the ability to influence and align with all key stakeholders
• Outstanding organizational skills; proven ability to drive execution, continuous improvement and innovation
• Excellent written and oral communication skills
• Ability to operate in a fast-paced, dynamic, multi-disciplinary industrial environment
• Fluency in Italian a plus, but not necessary

Education

Minimum BSc or equivalent in bioprocessing, chemical engineering, vector biology, or biological scien