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Healthcare Scientist
2 months ago
We are seeking a highly motivated and experienced Production Scientist to join our Newcastle Advanced Therapies Team within the Pharmacy Directorate. As a key member of our team, you will be responsible for the preparation and cryopreservation of cells and tissues from donations, as well as the manufacture of advanced therapeutic investigational medicinal products.
Key Responsibilities- Carry out preparation and cryopreservation of cells and tissues from donations, ensuring compliance with HTA, JACIE, GMP, and Quality Control regulations.
- Manufacture advanced therapeutic investigational medicinal products from cells or tissue, adhering to MHRA, GMP, and Quality Control guidelines.
- 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.
- Respond to laboratory equipment faults, procedural complications, or alarm states, implementing corrective actions and changes as necessary.
- 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.
- Ensure regulatory compliance with HTA, JACIE, MHRA, and local Quality Assurance System.
- Participate in 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.
- BSc in Scientific/Pharmaceutical subject or equivalent.
- HCPC registration or equivalent.
- 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.
- Computer literate.
- Skilled at workload planning and prioritisation.
- Excellent Communication skills.
- Ability to work as a team.
