13 Oct
Great Ormond Street Hospital for Children NHS Foundation Trust
London
Job description
Job summary
Applications are invited from experienced, flexible and motivated scientists, for a good manufacturing practice (GMP) lab technician role within the Cell and Gene Therapy Service (C>S;) at Great Ormond Street Hospital NHS Foundation Trust.
The C>S; supports the manufacture of advanced therapy medicinal products (ATMPs) for the treatment of childhood diseases, as part of a research programme involving University College London, Great Ormond Street Institute of Child Health (UCL GOS ICH) and external collaborators.
The successful candidate will be trained to work in an aseptic manner to undertake ATMP production and conduct important assays required to monitor the efficacy and safety of therapies,
in line with GMP regulatory requirements.
The ideal candidate will have previous experience of cell culture and optimisation, such as a research assistant who would like more direct involvement with GMP manufacture and advanced therapy clinical trials.
There is also considerable documentation involved in the preparation of each ATMP and as such, the applicant should be proficient with use of Microsoft Word and Microsoft Excel.
Please ensure that you read the attached job description and person specification carefully, as your application will be judged against these criteria.
For further information, or to arrange a visit, please contact Dr Annie Etuk via email : or by phone : 0207 405 9200 ext. 38304.
Main duties of the job
- Contribute towards optimisation and validation of GMP manufacturing processes applicable to ATMP clinical trials
- Participate in manufacturing of ATMP products for clinical trials
- Validate QC tests relevant to ATMP manufacture
- Write and implement new BMRs,
SOPs and worksheets
- Accurately complete GMP documentation related to, manufacturing, storage and shipment of ATMPs
- To comply with UK MHRA GMP and GCP regulations applying to ATMP manufacturing and conduct of first-into-man clinical trials
- To contribute to the overall normal activities of the research team and department as required, including laboratory duties and attendance at departmental meetings
- To ensure that equipment used is safe and maintained in good working order
- Manage stock control, ordering and receipt of goods for manufacturing in compliance with GMP regulations. Including critical starting materials such as viral vector and leukapheresis
- Organise shipments to / from external laboratories and completion of relevant documentation
- Participate in process simulations and media fills
- Support in liaising with key stakeholders and client organisations to report on progress and delivery against project milestones.
About us
GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role;
through a process that is fair, open, consistent and free from bias and discrimination.
We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged.
All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age,
disability status or length of time spent unemployed.
We particularly welcome applications from BAME communities, people with disabilities and / or long-term health conditions and LGBT+ community members.
We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently.
We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.
We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women's staff networks.
Staff networks are employee-led groups formed around interests, issues and a common bond or background.
Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust's mission, values and efforts specific to inclusion.
All of our staff networks are open to any employee.
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 knowledgerequired.
For bothdocumentsplease view the attachment / s below.
Person Specification
Culture and Values
Essential
Always Values
Academic / Professional qualification / Training
Essential
BSc in Medical Laboratory Science or completion of STP training programme or equivalent.
Desirable
GCP, GMP & HTA training
Experience / Knowledge
Essential
Experience of working in a CPA / UKAS accredited laboratory or other related translational laboratory
Desirable
- Understanding of the structure of a Pharmacy Quality System for manufacture under an MHRA license
- Experience of writing and following BMRs, SOPs and other key manufacturing documents
- Experience in GMP manufacturing
- Experience in the manufacture of ATMPs
- Experience in culture and / or manipulation of human primary cells and cell lines
- Experience in writing complex documents such as Product Specifications and technical sections for IMPDs
Skills / Abilities
Essential
- Excellent interpersonal skills
- Ability to work without supervision
- Good organisational skills and time management
- Demonstrated ability to prioritise and meet deadlines
- Preparation of high-quality written documents
Desirable
- Technical aptitude and ability to critically assess and improve processing methods and batch manufacturing