Laboratory Technician - GMP Manufacturing

GREAT ORMOND STREET HOSPITAL NHS FOUNDATION TRUST; City of Westminster; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading children's hospital in Westminster is seeking an experienced GMP lab technician to support the Cell and Gene Therapy Service. The role involves optimising and validating processes for advanced therapy medicinal products (ATMPs). Ideal candidates will have experience in cell culture and be proficient in Microsoft applications, with a keen attention to documentation and regulatory compliance. The successful candidate will contribute significantly to research and manufacturing efforts for childhood therapies. Competitive salary and support for diverse applicants offered.

Benefits

Accredited Living Wage Employer

Diversity and Inclusion initiatives

Support for staff networks

Qualifications

• Experience in good manufacturing practices (GMP) required.
• Ability to work in an aseptic manner is essential.
• Experience in documentation and regulatory compliance.

Responsibilities

• Contribute to optimisation and validation of GMP processes.
• Participate in manufacturing of ATMP products.
• Write and implement new BMRs, SOPs and worksheets.
• Ensure that equipment used is safe and maintained.
• Manage stock and orders for manufacturing.

Skills

Experience in cell culture

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Familiarity with Q-Pulse

Job description

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&GTS) at Great Ormond Street Hospital NHS Foundation Trust. The C&GTS 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. Prior experience in Q-Pulse document management system would be a significant advantage.

Please ensure that you read the attached job description and person specification carefully, as your application will be judged against these criteria.

Responsibilities

• 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.
• Comply with UK MHRA GMP and GCP regulations applying to ATMP manufacturing and conduct of first‑into‑man clinical trials.
• Contribute to the overall normal activities of the research team and department as required, including laboratory duties and attendance at departmental meetings.
• Ensure that equipment used is safe and maintained in good working order.
• Manage stock: ordering and receipt of goods for manufacturing in compliance with GMP regulations; including critical starting materials such as viral vector and leukapheresis. Conduct regular stock take of materials and consumables.
• 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.

Working for our organisation

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.

The recruitment process for all admin and clerical roles at Bands 2-4 will be a two‑stage recruitment process whereby shortlisted candidates will undertake an online literacy, numeracy, ICT and typing test. Only those candidates who pass the competency test will proceed to a formal interview.

The closing date given is a guide only. There may be some occasions where we have to close a vacancy once sufficient applications have been received. It is therefore advisable that you submit your application as early as possible to avoid disappointment.

Only those candidates who clearly demonstrate how they meet the person specification criteria for this post will be shortlisted. Please note that where high volumes of applicants have been received, additional criteria may on occasion be used to determine the final shortlist.

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).

We are an accredited Living Wage Employer.