A clinical stage T – Cell Therapy company who are pioneers in the Cell & Gene Therapy sector with therapies advancing through clinical trials that are due to be commercialised within the next 18 months. They are seeking a Director of Vector Manufacturing to take the lead of their Vector operations, develop and grow this function to keep pace with the company’s growth. Their manufacturing operations are based in Stevenage which are scaling up to keep pace with the increasing volume needed and other therapies entering the clinic.
Their Vector Manufacturing Operations reflects this with a small team at present that has been earmarked for growth and needs a Director of Vector Manufacturing. This is an influential position which will enable you to make an impact with responsibilities including the provision of leadership, developing & executing strategy, tech transfer and the growth of this function.
The key responsibilities are:
- Provision of GMP Vector material via either internal or outsourced operations for use in clinical trials
- Develop strategy for the growth of team & function working with relevant VP’s and Senior Management
- Build and develop the group and their capabilities including – set up of in-house facilities & recruitment of personnel for example
- Work with VP of Process Development to transfer processes into manufacturing operations
- Work with Director of Quality to ensure compliance is maintained
- Manage outsourced manufacturing operations
- Lead regulatory audits and be a Key representative of the company
This opportunity offers you the chance to take the lead of a key function and develop your career as the company grows, in particular this function because it has been earmarked for continued expansion. Which you will have the opportunity to lead.
Desired Skills and Experience:
- GMP manufacturing of Viral Vectors (preferably) or other related products such as ATMP’s
- Good knowledge of Viral Vector biology
- Strong Leadership capabilities
- Prior experience of biopharma processes e.g quality, compliance, and process development for example
- Experience at dealing with regulatory agencies.
The Company: The company are a pioneering and ambitious Biopharmaceutical company who have developed next-generation, programmed T-cell therapies to treat haematological cancers and solid tumours. 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.