Director of Cambridge Cellular Therapies Laboratory (Band 9)

Director of Cambridge Cellular Therapies Laboratory (Band 9)
HCPC Registered
GBP543 per day (Inside IR35)
37.5 Hours per week
Interim Contract
Cambridge, Cambridgeshire (Commutable from Milton Keynes, Chelmsford, Peterborough, Colchester, Ipswich)

My Client with an office based in Addenbrooke's Hospital are seeking a Director of Cambridge Cellular Therapies Laboratory on a Interim contract basis with (37.5 hours a week) paying GBP543 per day

Job Summary
The post holder is primarily responsible for the provision and delivery of a comprehensive cellular therapy laboratory service. This includes the provision of consultant level expertise and taking responsibility for the production and issue of blood and bone marrow products, Immune effector cells (IECs) and other Advance Therapy Medicinal Products (ATMPs) within the Cambridge Haematopoietic Cellular Therapy Programme, Neurology, Orthopaedics and other specialties as required.

In addition the post holder will:

• Be accountable for the Trust's Good Manufacturing Practice (GMP)-compliant facility to ensure corporate compliance with UK and European legislation.
• Be the Designated Individual on the Trust's therapeutic Human Tissue Authority (HTA) licence and ensure compliance with the Human Tissue Act on behalf of the Trust
• Be responsible for initiating, directing and supervising a programme of audit, clinical governance and quality management in the field of cellular therapy
• Be working with University academics and research groups in preclinical and translational research in all areas of cellular therapy including being responsible for development of GMP grade products for the delivery of clinical trials.
• Be responsible for providing support for academic and clinical services in respect to all regulatory requirements in relation to cellular therapies.
• Be responsible for ensuring the publication and presentation of data in peer reviewed literature and at national and international meetings.
• Be expected to contribute to the formulation of national policy through professional bodies.
• Support teaching, as appropriate, of medical students, doctors, nurses and scientists in the Trust and Cambridge University.
• Interact with Pharma on commercial Cellular Therapy trials

Experience

• Significant experience in the development, manufacture, distribution and delivery of cell and gene-based therapy products
• In-depth technical experience of cell manipulation, isolation/purification, culture, transduction and washing/volume reduction
• Experience of working with academic partners
• Working knowledge of UK, European and international regulatory requirements
• Budget management of significant size and complexity
• Demonstrable success in instigating, leading and managing change
• Relevant experience in technology transfer from the biotechnology or pharma industry

Knowledge

• In-depth knowledge of regulatory requirement related to ATMPs including HTA, JACIE, MHRA/EMA, ICH, GMP, GLP and European tissue directive regulatory requirements
• Workforce planning, recruitment, retention and staff development including performance management
• Multiagency working at a strategic level
• GCP
• Clinical Trial SOP development.

Skills

• Excellent written and oral communication skills at all levels of the organisation including strong liaison and negotiation skills
• Excellent interpersonal skills
• Outstanding organizational skills
• Leadership and ability to motivate and empower others
• Positive effective team worker
• Ability to prioritise work, meeting tight deadlines and work independently
• Judgment and analytical skills
• Able to translate complex sensitive issues and problems into plans which can be clearly articulated and understandable to others
• Able to deliver flexible and creative solutions to difficult problems and challenges.
• Analyse, present and tailor complex data and information to a wide range of audiences
• Demonstrate political judgment and astuteness in working with complex policy and diverse interest groups
• Intellectually flexible to work beyond existing structures and ways of working to deliver effective services

Qualifications

• Minimum BSc or equivalent in bioprocessing, chemical engineering, or biological sciences
• PhD or equivalent research experience
• QP qualification
• FRC Path