Associate Director – Viral Vector Operations
|Job Title:||Associate Director – Viral Vector Operations|
|Salary:||Competitive DoE plus Bonus and Benefits|
|Contact Name:||James Hume|
|Job Published:||October 19, 2018 13:18|
A pioneering and ambitious Biopharmaceutical company who develop next-generation, programmed T-cell therapies to treat haematological cancers and solid tumours. The organisation has existed for 4 years and is very well funded, with a clear strategy and expansion plan for the next 3 years and beyond. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.
The Associate Director will report directly to the SVP for Product Delivery and has the responsibility for the delivery of viral vector clinical trial material. You will be leading a team who have the responsibility of delivering viral vectors for clinical trial programmes. In the short term this is to receive, qualify, implementing processes and assays suitable for producing of GMP viral vectors for clinical trial programmes. You will work closely with the Head of Quality to ensure compliance to cGMP, plus help design and implement the Quality Management System to meet their changing needs.
The company has a well-planned strategy to meet their longer term aims and part of this is to develop in house GMP manufacturing capabilities. A site has been selected and you will be a part of the project team for its construction and set up. This includes the installation & qualification of equipment, optimized manufacturing operations as well as the recruitment and development of staff for viral vector operations.
Due to the level and responsibilities of this role they are seeking someone with their own ideas and vision to achieve company ambitions rather than simply follow orders. This role will be highly visible and not only comes with growth on the role over the next few years but also longer term career development prospects.
This role will be primarily at their Stevenage site where the Product Delivery Operations are based, with limited travel to their London main site and another site based in North London.
Desired Skills and Competencies:
For this role, you will need to have demonstrable experience of working directly with viral vectors or associated processes within the Biopharmaceutical, Pharmaceutical, Cell & Gene Therapy Sectors at a senior level. You will need to be well versed in quality and regulatory compliance, regulatory submissions, including liaison with regulatory bodies. From a technical perspective, you will need to be experienced with cell based processes, cell based assays, viral vector biology, and cell biology. You will need to have line management experience of teams of scientists whether small or large. If you have experience of setting up operations and working with contract organisations at a senior level this is advantageous to your applications.