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Deputy Production Manager (Stem Cell Scientist)

The Medicines And Healthcare Products Regulatory Agency - Scientific Research and Innovation group

Location: London, South Mimms
Salary: £41,185
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 1st February 2023
Closes: 20th February 2023
Job Ref: 266003

£40,451 per annum plus benefits

Permanent/Full Time

Location: South Mimms, Hertfordshire

Ref: 266003

We are currently looking for a Deputy Production Manager (Stem Cell Scientist) to join our Research and Development function within the Scientific Research and Innovation group.

This is a full-time opportunity, on a 12-month fixed term contract basis. This role is primarily based at our South Mimms site with occasional remote working a possibility, dependent upon the nature of the role. Not all roles will be suitable for remote working. Please be aware that this role can only be worked in the UK and not overseas.

Who are we?

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

Research and Development hosts and nurtures the current excellence in research into biologicals, biological reference materials, biological activity measurements, product quality testing and standardisation. This is a statutory activity and includes international centres of excellence such as those working on polio, influenza and the UK Stem Cell Bank.  The Biotherapeutics and Advanced Therapies Team in the R&D function of the SR&I group comprises a multi-disciplinary team of internationally respected scientists whose focus is on the regulatory research required to ensure safe and effective Advanced Therapy medicines are available to patients.

What’s the role?

The successful candidate will play a key role in the QC of banked Human ES cell lines at the UKSCB which is the sole repository for Human ES cell lines derived in the UK. Support the R&D function of the Biotherapeutics and Advanced therapies division by participating in ongoing projects. Maintain Quality Systems operating in the Group (HTA and ISO 9001) and ensure effective service delivery by supporting banking and quality control testing of cell lines.

Key responsibilities:

  • Ensure effective service delivery by carrying out quality control testing of human embryonic stem cells according to UKSCB standard operating procedures and ensuring HTA compliance; maintaining quality control records and cell line documentation.
  • Provide scientific and technical input into the banking programme and other relevant R&D projects. Write reports and scientific publications.
  • Support the Head of Cell Production as required. Including, but not limited to: ensuring banks of cell lines are QC tested according to documented procedures and specifications and managing day to day clean-room facility activities (stock surveillance, equipment maintenance, cleaning, environmental monitoring, EMS system monitoring, validation studies).
  • Maintain Quality Systems operating in the Group (HTA and ISO 9001). Write, review and maintain quality records, including cell line documentation, qualification and validation reports, standard operating procedures, COSHH and risk assessments. Manage the UKSCB low temperature storage system including auditing and spot checks to ensure traceability for HTA and ISO 9001 compliance. Inspect critical equipment and components as required.

Who are we looking for?

The successful candidate will have a PhD in a relevant discipline or equivalent experience. You will have experience with HES cells, flow cytometry and qPCR. You will demonstrate the ability of working in a team with excellent communication skills, ability to organise own time and prioritise. You will have knowledge of HTA / working under a quality management system. You will demonstrate the ability to be focussed and have attention to detail.

Closing date: 20th February 2023.

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