Lead Device & Delivery Scientist - London
Jason Johal at CK Science is currently recruiting for a Lead Device and Delivery Scientist to join a major new initiative to grow a cell therapy industry delivering health and wealth for the UK. Its vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapies, and a place where businesses can start, and confidently grow.
The company are currently developing a £55 million UK cell manufacturing centre to be based in Hertfordshire. The purpose of this facility will be the GMP manufacture of cell and gene products for Phase III clinical trials, to augment the current UK manufacturing capability, which is anticipated to reach capacity by 2017. This large scale manufacturing centre will supplement the process development and scale-up capabilities already established in-house at the company's development laboratories in London.
This has created a new opportunity for a Lead Device and Delivery Scientist to work with the Head of Process Development to help contribute to many of the day to day activities of the Cell Therapy Catapult. The role will be a high profile one, both within the organisation and externally facing. The person will be responsible for the development of the company's viral vector industrial strategy and will provide leadership and management of key collaborations, from both academia and industry. The individual will be accountable for a team of scientists responsible for delivering development projects.Centralised and de-centralised manufacturing strategies are maturing and both will play an important role in the future commercial cell therapy supply chain. The purpose of this role is to provide both a strategic vision and to lead on project delivery of novel medical devices both within GMP facilities, and at point of care. The successful candidate will take full responsibility for the day to day management of the development and delivery of point of care medical device assigned projects. To deliver on this vision they will:-
- Work closely with all relevant internal and external stakeholders to ensure successful delivery to schedule and within budget.
- Articulate a vision for enabling technologies and implement this strategy to deliver on the company's point of care manufacturing goals
- Deliver a series of enabling projects with immediate industry benefit which will allow future realisation of the strategic delivery plan
- Ensure project compliance in biocompatibility, risk assessment, usability, clinical data, sterilization, process approach, etc.
- Capture resulting intellectual property and help develop subsequent commercialisation strategy to deliver best value for the asset.
You are required to have the following qualifications, skills and experience:
- Experience of working within medical device companies that include new device development for novel therapies
- Experience in the manufacturing, distribution and sales of medical devices in particular class IIa but also classes I, Ilb and lll
- Broad scientific and commercial technical expertise with ability to apply knowledge to problem solving
- Experience of working within Quality Management Systems.
- Experience of working to GMP regulations within the manufacture of cell therapies, vaccines or biologics.
- Experience in writing and carrying out GMP production protocols.
- Experience of delivering on agreed commercial objectives.
- Validation, trouble shooting, development and scale-up within novel medicinal products.
- Comfortable within the IVD space including proven experience with novel medical devices and / or in-vitro diagnostics medical devices
- Proven ability to consistently deliver to time, cost and quality standards· Track record of project, publication or patent delivery
- Extensive experience working in device development, with a significant portion being in industry
- A PhD or EngD is essential (or equivalent)
If successful you will be joining a new initiative that is the UK's response to the translational gap between early-stage research and the later stages of clinical development in regenerative medicine and that will be shaping the UK cell therapy landscape.
For more information or to apply for this Lead Device & Delivery Scientist position please contact Jason on +44 (0)1438 723 500 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
Entitlement to work in the EEA is essential. Please quote reference ST33464 in all correspondence.