Manufacturing Specialist - Upstream Expert (USA, Remote) - Haybury Limited : Job Details

Upstream 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, they are seeking a highly experienced Upstream Expert to join their CMC team. This role will be pivotal in designing, optimizing, and managing cell culture and upstream processes for AAV therapeutic vector production.

Key Responsibilities:

• Drive the optimisation of cell culture manufacturing unit operations to prepare for commercial production, integrating new technologies and ensuring alignment with industry and regulatory expectations
• Serve as the key technical expert for upstream processing; guiding process development, GMP manufacturing, technology transfers, and collaborations with external stakeholders.
• Develop and enhance cell culture-based manufacturing processes for 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 cell culture-based therapeutics (gene therapy preferred)
• Experiences in late-stage process and commercialisation
• Contribution to BLA filing
• Expertise in in the production of cell culture-based therapeutics, encompassing cell biology, cell growth, cellular production mechanisms, the effects of culture conditions, and the influence of raw materials, 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 regulatory requirements of cell-culture based biomanufacturing processes, including testing of cell lines and process intermediates
• Highly analytical mindset with the ability to trouble-shoot in an effective and organised manner

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 vision care.