Healthcare Scientist

3 days ago

Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom NHS Full time
Job Title: Healthcare Scientist/Production Scientist

We are seeking a highly motivated and experienced Healthcare Scientist/Production Scientist to join our team at the Newcastle upon Tyne Hospitals NHS Foundation Trust. As a key member of our Advanced Therapies Team, you will play a crucial role in the preparation and manufacture of advanced therapeutic investigational medicinal products.

Main Responsibilities:
  • Carry out preparation and/or cryopreservation of cells and tissues from donations, ensuring compliance with Quality Assurance, Regulatory Compliance with HTA & JACIE, GMP and Quality Control.
  • Manufacture advanced therapeutic investigational medicinal products from cells or tissue, adhering to Quality Assurance, Regulatory compliance with MHRA, GMP and Quality Control.
  • Oversee technical staff in the preparation of specimens for analysis, including reception, processing, preservation, labelling, storage, distribution and disposal of products.
  • Maintain accurate and legible written and electronic records in accordance with local data integrity policy.
  • Operate, maintain and monitor clean rooms in accordance with HTA/MHRA/JACIE requirements.
  • Assist in the recovery and infusion of cellular products.
  • Respond to laboratory equipment faults, procedural complications or alarm states, offering corrective actions and implementing changes as necessary.
  • Report faults and deviations to a senior member of staff and take prompt action in response to unexpected situations.
  • Carry out laboratory diagnostic tests, validate results and determine further tests or actions required.
  • Provide advice, support and supervision to Technical staff and guest users of the facility.
  • Liaise closely with clinical teams and QC testing laboratories to coordinate receipt of cells, product testing and re-infusions across multiple sites.
  • Verify and relay critical information regarding donations and cellular products to the Newcastle Advanced Therapies team and service users.
  • Attend clinical areas (wards, theatres) to assist clinical staff in the delivery and administration of Cell, Gene and Tissue products.
  • Ensure regulatory compliance with HTA, JACIE, MHRA and GMP requirements.
  • Participate in clinical trial activities in accordance with GMP and GCP requirements.
  • Contribute to service and product improvement through continual education and training, taking an active role in policy, product and service development.
  • Participate in departmental audit, correct and record minor non-compliance and report major deviations to a senior member of staff.
  • Take responsibility for own learning and development, maintaining a personal training record and ensuring all mandatory Trust and departmental training is performed in a timely manner.
  • Work in compliance with local health and safety rules to ensure a safe working environment.
Person Specification:
  • BSc in Scientific/Pharmaceutical subject or equivalent.
  • HCPC registration or equivalent.
Knowledge and Experience:
  • Knowledge in Transfusion or Transplantation Science.
  • Knowledge of GMP.
  • Knowledge of GCP.
  • Quality Control Awareness.
  • Experience of fluorescence-activated cell sorting (FACS).
  • Experience of aseptic processing.
  • Experience of cell culture.
  • Experience of clinical trials.
  • Experience of working in Isolators and Class 2 Safety Cabinets.
Skills and Abilities:
  • Skilled at workload planning and prioritisation.
  • Ability to work as a team.

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