Advance Therapy Product Translational Scientist

Job overview

The John Goldman Centre for Cellular Therapy based at Hammersmith Hospital is a HTA, JACIE and MHRA IMP / ATMP licensed facility that provides highly specialist clinical, technical and scientific services for Bone Marrow transplant patients.

Applications are invited from well-motivated and organised individuals who will be involved in all aspects of GMP clinical processing (including advanced ATMP protocols and cell culture), flow cytometry and other quality testing.

The Advanced Therapy Product Translational Scientist will additionally be the lead in service developments such as ATMP validations, introduction of new techniques into the laboratory, quality system development, training, data management, assisting new / on-going translational research, handling commercially approved ATMP for clinical application, assisting in Clinical trials approval and bringing new therapies into clinical practice.

Applicants must have HCPC registration, minimum of an MSC level qualification with practical experience of GMP ATP manufacture / development or handling. Applicants should have direct experience in this field or in a related area such as Blood Transfusion, Immunology or ATP development under GMP conditions. In order to meet the needs of a high-quality service, the post holder is expected to be flexible in their working arrangements and be able to demonstrate the ability to work consistently under pressure to the highest standards.

Main

duties of the job

• To work with the Clinical Trials Lead and JGCCT Director to ensure that the JGCCT is ready to successfully delivery Advanced Therapy Medicinal Products (ATMPs) and Advanced Therapy Medicinal Investigational Products (ATMIPs) both within clinical trial and clinical practice setting.
• To engage with all relevant stakeholders (internal and external) such as ATMP manufacturer(s), Pharmacy Clinical Trials & ATMPs and NHS clinical and research staff, Novel Activity and other relevant committees as applicable within the context of ATMP / ATIMPs provision at the Trust.
• To develop and maintain all necessary standard operating procedures, documents, labels and guidelines in relation to ATMPs in conjunction with Pharmacy Clinical Trials & ATMP staff.
• Lead laboratory ATMP manufacture and testing ready for clinical use.
• Help monitor the clinical trial activity and reimbursement charges for the JGCCT.

Working for our organisation

At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care.

Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You’ll get an experience like no other and will fast forward your career.

Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to Work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.

We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part time or job share. Please talk to us at interview.

Detailed job description and main responsibilities

To work with the Clinical Trials Lead and JGCCT Director to ensure that the JGCCT is ready to successfully delivery Advanced Therapy Medicinal Products (ATMPs) and Advanced Therapy Medicinal Investigational Products (ATMIPs) both within clinical trial and clinical practice setting.

Refer to the Job Description for detailed duties and responsibilities.

Person specification Education / Qualification Essential criteria

• MSc in appropriate specialist subject
• Health and Care Professions Council registration or Equivlent
• Good Manufacturing Practice (GMP) training / course.

Desirable criteria

• Quality Management course.
• GCP Training

Experience Essential criteria

• Minimum 2 years’ experience in Blood Transfusion Science, Immunology or ATMP development laboratory with GMP
• Commercial ATMP handling

Desirable criteria

• Experience working in Grade B clean room production environment
• Experience of HPC processing and HPC quality testing.
• ATMP / Clinical Trial process development experience
• Experience in liaising with multidisciplinary teams

Values and behaviours Essential criteria

• Proactive
• Good interpersonal and organisational skills
• Good communicator across diverse staff groups
• Team worker

Skills / knowledge / abilities Essential criteria

• Excellent verbal and written communication skills
• Good ability to organise and prioritise work
• Technical aptitude
• Ability to work independently as well as in a team
• Problem solving skills

Physical Qualities Essential criteria

• Good general health / fitness to practice to enable to fulfil the requirements of the role

Right to work

If you need sponsorship to work in the UK, please visit the Home Office website for information on sponsorship and visa status before you fill in your application form. Due to recent changes in the UK immigration rules which affect Skilled…