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Laboratory Technician - GMP Manufacturing

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Great Ormond Street Hospital for Children NHS Foundation Trust

2mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Science
    Research & Development
  • London

AI generated summary

  • You need experience in cell culture, GMP, documentation skills, and proficiency in Microsoft Word and Excel. Review the job description and person specification for specific criteria.
  • You will optimize GMP processes, manufacture ATMPs, validate QC tests, complete documentation, manage stock, organize shipments, and support team activities and stakeholder communication.

Requirements

  • 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 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.

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.
  • 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: 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.

FAQs

What qualifications are required for the Laboratory Technician - GMP Manufacturing position?

The ideal candidate should have previous experience in cell culture and optimisation, preferably as a research assistant, along with proficiency in Microsoft Word and Excel.

Is experience in GMP manufacturing necessary for this role?

While previous experience in GMP manufacturing is preferred, candidates with relevant cell culture experience and a willingness to learn about GMP processes are encouraged to apply.

What type of training will be provided for successful candidates?

Successful candidates will receive training to work in an aseptic manner to undertake ATMP production and conduct assays required to monitor the efficacy and safety of therapies in line with GMP regulatory requirements.

What kind of documentation is involved in this role?

The role involves considerable documentation related to manufacturing, storage, and shipment of ATMPs, including the writing and implementation of Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs).

How does the team ensure compliance with regulatory requirements?

The team complies with UK MHRA GMP and GCP regulations applicable to ATMP manufacturing and the conduct of first-into-man clinical trials.

What are the main responsibilities of the Laboratory Technician?

Main responsibilities include participating in the manufacturing of ATMP products, validating QC tests, managing stock, organising shipments, and contributing to laboratory duties as part of a research team.

Is there an opportunity for advancement within the position?

Growth opportunities may exist as the role involves collaboration on clinical trials and the chance to contribute to process optimisation and validation.

What support does GOSH provide for diversity and inclusion?

GOSH is committed to being a diverse and inclusive employer, with policies in place to ensure fair treatment, as well as active staff networks for various communities such as BAME, LGBT+, and Disability.

How can I get more information about the role or arrange a visit?

For further details or to arrange a visit, you can contact Dr. Annie Etuk via email at annie.etuk@gosh.nhs.uk or by phone at 0207 405 9200 ext. 38304.

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Great Ormond Street Hospital for Children NHS Foundation Trust

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Science & Healthcare
Industry
1001-5000
Employees

Mission & Purpose

Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) is a national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK. It aspires to offer outcomes for children in the top five in the world. The largest centre in the UK for children with heart or brain problems, and, with UCLH it is the largest centre in Europe for children with cancer. It is the only specialist Biomedical Research Centre for paediatrics, it works in partnership with the UCL Institute of Child Health (ICH), part of University College London, and together they form the largest paediatric research and teaching centre in the UK, and one of the largest in the world. The hospital at Great Ormond Street is the only exclusively specialist children's hospital in the UK. It does not have an Accident and Emergency department and largely only accepts specialist referrals from other hospitals and community services. The population of children served by the hospital is characterised by those with multiple disabilities and/or health problems and rare and congenital (present at birth) conditions.