The project is to lead the delivery of a key programme to attain US FDA approval for their cell and gene manufacturing operations. There will be a particular focus on one partner organisation based in their GMP multi occupancy manufacturing facility in Stevenage. This role will be reporting to both senior stakeholders and the board of the company because you will be managing and delivering this project. This role will require the development of a very strong relationship with the relevant collaborator using a high level of diplomatic ability.
An overview of the responsibilities is:
- To be responsible for the delivery of project to secure US FDA approval for commercial cell & gene therapy manufacture within 24 months
- Ensure each specific milestones of the project are achieved and adhered to.
- Work with relevant internal and external workstream leads to deliver strategic aims of both workstreams are delivered.
- Take responsibility for the budget including CapEx and OpEx budgets
- Support the Director of Quality and relevant FDA internal experts as well as 3rd parties when conducting gap analysis and mock FDA inspection.
- Drive this complex project through working with internal senior leadership, external collaborator senior leaders and key regulatory stakeholders.
This is an exceptional opportunity where you can lead a project that will have significant impact not just internally but on this emerging and impactful sector.
Please note: This is a 15 month Fixed Term Contract with potential to extend.
Desired Skills and Competencies:
They are seeking a high calibre individual who has programme / project management experience within the broader Biopharma sector with GMP manufacturing experience.
- Project management within GMP manufacturing environments in the Biopharma sector
- Specific cell and / or gene therapy experience is an advantage but not essential
- Knowledge of FDA & EU / MHRA regulatory requirements
- Demonstrable delivery of complicated manufacturing projects
- Ability to work with collaborators and external 3rd parties.
The company are a centre of excellence that are driving the cell & gene therapy sector forward through adopting innovative approaches and the adoption of new technologies with projects coming from the UK, Europe, US and Asia. Their headquarters are in Central London where they have market leading capabilities to take a therapy from concept, across the translational gap, to the clinic and through clinical trials. They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialisation of these fast developing, cutting edge technologies Their longer term aim is to make the UK a global leader in the development and commercialisation of these life changing therapies.