Job summary
Great Ormond Street Hospital (GOSH) is looking for a Processing and Governance Manager for Cellular Therapies. As the Processing and Governance Manager, you will manage the Cell Therapy Unit alongside the Director of Cell Therapy. This includes overseeing a new GMP facility with MHRA and HTA licensed laboratories, ensuring compliancewith GMP, HTA, JACIE, and UKAS.
Essential qualifications required include a Honours Degree and MSc or equivalent in a relevant scientific discipline. Active Professional Registration with Health Care Profession Council or the Royal PharmaceuticalSociety. You will also have experience in GMP, quality, laboratory management, translational cell and gene therapy, HTA requirements, and Health and Safety.
Main duties of the job
Ensuring products are produced and stored according to quality standards
Maintain department, premises, and equipment qualifications
Ensure appropriate validations and staff training
Lead management reviews of process performance and quality management systems
Manage Cell Therapy scientific and support staff
Support translational research and clinical trials
About us
We are keen to make our workforce as diverse as the communities we serve, and we hope to attract applications from underrepresented groups, including people with Black, Asian and Minority Ethnic heritage, people with a disability, and people from LGBTQ+ communities. By growing an ever more diverse workforce, we'll have a greater range of perspectives and knowledge, meaning that we can provide the children and young people at our hospital with even better care.
Our hospital is committed to creating an environment that is open and inclusive. Our staff are encouraged to engage with colleagues through the following networks: REACH (Race, Ethnicity and Cultural Heritage) ENABLED (Enhancing Abilities & Leveraging Disabilities Network), PRIDE and Women's networks; all of which are sponsored by a member of our Executive Management Team.
We want to ensure that all of our people, regardless of their background, are seen and heard. We want to attract applicants that share our commitment to inclusion and that understand diversity is a strength that is embraced and valued.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below
Person Specification
Combined Values
Essential
Academic/Professional qualification/Training
Essential
- Honours degree or equivalent in a relevant scientific discipline
- MSc or equivalent in appropriate specialty
- Registration with Health Care Profession Council or Royal Pharmaceutical Society
Desirable
- PhD in scientific discipline
Experience/Knowledge
Essential
- Appropriate specialist knowledge of cell-based therapies
- Knowledge of HTA and MHRA regulatory guidelines in relation to cell therapies
- Knowledge of research governance, ISO standards and accreditation
- Experience of translational research, GLP/GMP and/or GCP in gene and/or cell therapy
- Experience of budgets and financial planning
- Line management or supervisory experience
- Experience of Quality Management Systems
- Experience of external regulatory inspections i.e. MHRA, HTA, UKAS and JACIE inspection
- Familiar with and competent in laboratory IT systems and other relevant software packages, including databases and document control.
Desirable
- Experience of Laboratory modernisation and managing change in NHS environment
Person Specification
Combined Values
Essential
Academic/Professional qualification/Training
Essential
- Honours degree or equivalent in a relevant scientific discipline
- MSc or equivalent in appropriate specialty
- Registration with Health Care Profession Council or Royal Pharmaceutical Society
Desirable
- PhD in scientific discipline
Experience/Knowledge
Essential
- Appropriate specialist knowledge of cell-based therapies
- Knowledge of HTA and MHRA regulatory guidelines in relation to cell therapies
- Knowledge of research governance, ISO standards and accreditation
- Experience of translational research, GLP/GMP and/or GCP in gene and/or cell therapy
- Experience of budgets and financial planning
- Line management or supervisory experience
- Experience of Quality Management Systems
- Experience of external regulatory inspections i.e. MHRA, HTA, UKAS and JACIE inspection
- Familiar with and competent in laboratory IT systems and other relevant software packages, including databases and document control.
Desirable
- Experience of Laboratory modernisation and managing change in NHS environment
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Employer details
Employer name
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
