Director AAV Gene Therapy

Posted 4 days ago
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Job Description

Overview
We are undertaking a exclusive search for a rapidly expanding biotech company in the UK – Cambridge, they are looking for a Head of Gene therapy, and will likely get accelerated approval for their promising GT candidate that is in late phase clinical trials. With enormous potential for rare diseases.

Responsibilities

You will oversee the entire technical operations group responsible for creating drugs in clinical trials and for scaling production of those drugs for commercialisation bringing it to the market. You will lead a team of 15 – soon to be 30 by the end of the year – working with state of the art equipment and manufacturing processes. Overall you will be sure to improve patients lives by bringing these important drugs to market. 

Summary

You will report to the VP of Gene manufacturing science and technology and as part of the executive leadership team driving the company toward further strategic approaches to gene therapy products and ideas:

  • Provide technical and scientific leadership through partnerships with site’s functions and third parties to introduce and maintain commercially viable and robust products.
  • Provide enhanced technical support for Gene Therapy Drug substance and Drug Product
  • Provide front line manufacturing support for Biologics Drug substance manufacturing
  • Serve as a member of the home site leadership team and contribute to the overall strategy, performance and direction of the site in the development of the Site Business plans, Site Facility Master Plans and prolonged future strategy for the next 5 years

Responsibilities

  • Lead the GT CoE team of scientists responsible for technical oversight of the Gene Therapy drug substance and Drug Product commercial manufacturing both internally and externally.
  • Responsible for the introduction of products and for technical transfers from Technical Development to Manufacturing internally or external through contracted organizations for third party products (CMO’s).
  • Validate products to ensure commercial viability in accordance with regulatory requirements.
  • Ensures the process control strategy is translated commercially and maintained for the safety and quality of our manufactured products.
  • Support and, where appropriate, lead optimization of pharmaceutical processes by applying sound scientific reasoning and following integrated process and technology strategies.
  • Support continuous improvement in MSAT processes using Operational Excellence principles and relevant tools.
  • Works with the other Centers of Excellence, Manufacturing Sites and Technical Development to drive robustness and productivity initiatives for commercial products.
  • Lead a lab-based group of scientists capable of performing scale-down models of cell culture and purification processes with their associated analytical methods to support on-going process investigations, changes, validation, and process improvement initiatives.
  • Leads the MSAT manufacturing interface team responsible for the continuous application of the process control strategy as integral members of the site process teams.
  • Leads the CoE Process Steward group who are responsible for technical oversight of the processes under the centers remit.
  • Work closely with Technical Development to provide input during development and lead knowledge transfer from Process Sciences to production regarding product and manufacturing process.
  • Identify, recruit, develop and retain qualified individuals to provide technical support to the site. Creates and maintains an environment of teamwork and collaboration while developing and motivating a high performing team that models the organization values and attributes.
  • Serve as an influential member of the GMSAT leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions.


EDUCATION

PhD. degree preferred.

Experience

EXPERIENCE

  • Experience in Biopharma GT Drug Substance and DP Manufacturing strongly preferred.
  • Technical Leadership experience at a Director level strongly preferred.
  • 15+ years of professional experience in the pharmaceutical industry, including managerial experience. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology)
  • Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of Biologics.
  • Advanced project management experience/skills required including method transfers, and risk assessment.
  • Knowledge of OPEX principles and tools, and knowledge of R&D processes.
  • Demonstrated to lead and develop an effective team of senior scientists and engineers in a global context
  • Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
  • Experience collaborating effectively with other functional groups to achieve business objectives.