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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

1. Lead the strategic direction of Orchard’s platform Suspension LVV in collaboration with key external partners across multiple projects at various stages of development.

2. Build and manage a high-performing internal LVV team fostering technical expertise and cross-functional collaboration.

3. Conduct landscape scouting to identify innovations that drive continuous improvement in quality, yield and COGs.

4. Foster a strong collaboration with our key CMOs to ensure alignment, quality, and achievement of mutually defined goals

5. Develop and implement a COGS optimized lentiviral process ensuring high quality, and process robustness enabling better patient access to treatment.

6. Provide technical leadership and expert oversight during GMP production, testing and fill/finish of lentiviral vectors at CMO's.

7. Establish a robust scale down model for suspension LVV production to ensure process understanding and enable effective optimization at scale production.

8. Provide expert support in design and assessment of PPQ activities to ensure high quality commercial ready processes.

9. 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.

10. Serve as person-in-plant during key production campaigns and development/validation activities

11. Assist in the reporting, investigation and resolution of deviations encountered during GMP production activities

12. 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

13. Provide support for creation and expert review of source technical documents and Quality sections of regulatory submissions (IND/CTA/Briefing books).

14. Contribute to internal initiatives and support additional activities related to suspension LVV development and manufacturing.

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

o Upstream cell culture, downstream processing, and fill finish operations

o 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 sciences