Downstream Expert, Gene Therapy

We are partnering with a pioneering gene therapy company dedicated to improving the lives of patients with high unmet medical need and complex, life-changing disorders.

This innovative organization is at the forefront of developing next-generation AAV gene therapies by combining strong scientific foundation, cutting-edge programs and advanced manufacturing capabilities with novel approaches to gene therapy.

As part of their expansion, we are seeking a highly experienced Downstream Expert to join their CMC team. Your expertise will be critical in shaping a commercial-ready manufacturing process that directly impacts the development of revolutionary gene therapies.

Key Responsibilities:

• Drive the optimisation of purification processes to prepare for commercial production, integrating new technologies and ensuring alignment with industry and regulatory expectations
• Serve as the key technical expert for downstream processing; guiding process development, GMP manufacturing, technology transfers, and collaborations with external stakeholders.
• Develop and enhance purification manufacturing processes to support the production of AAV therapeutic vectors, ensuring efficiency and robustness.
• Oversee the planning and execution of development and manufacturing campaigns with external partners, ensuring alignment with quality and regulatory standards.
• Proactively address and resolve technical challenges with external collaborators, fostering productive relationships to achieve project goals.

The ideal candidate will have:

• Master’s or PhD in Biotechnology, Engineering, or related fields.
• 6+ years of experience in biologics (gene therapy preferred)
• Experience in late-stage process and commercialisation, including PPQ, Process Validation, Characterisation, etc.
• Contribution to BLA filing
• Expertise in purification techniques for cell culture-based therapeutics; advanced knowledge of protein, macromolecule, and viral separation technologies, with hands-on experience in AAV vector research and production.
• Ability to analyse and interpret performance and quality data for purification processes using metrics, tools, and methods such as QbD and DoE to optimise outcomes.
• Development and implementation of manufacturing control strategies, including defining quality attributes, identifying critical process parameters, and setting appropriate specifications.
• Can operate effectively within regulated environments, ensuring compliance with GMP standards and supporting biomanufacturing processes.
• Strong experience in leading and managing projects by establishing clear plans, tracking milestones, and reporting progress while maintaining excellent communication with stakeholders.

Join this forward-thinking company at the forefront of innovation, where you’ll have the opportunity to contribute to ground-breaking advancements in gene therapy that are transforming lives. Working with cutting-edge technologies in a dynamic, mission-driven environment, you'll be making a direct and meaningful impact on patients' lives and helping to shape the future of advanced treatments for complex disorders