Detailed job description and main responsibilities

• To carry out preparation and / or cryopreservation of cells and tissues from donations, having successfully completed the in-house competency based training programme that encompasses the concepts of Quality Assurance, Regulatory Compliance with HTA & JACIE, GMP and Quality Control.
• To carry out the manufacture of advanced therapeutic investigational medicinal products, from cells or tissue, having successfully completed the in-house competency based training programme that encompasses the concepts of Quality Assurance, Regulatory compliance with MHRA, GMP and Quality Control.
• To oversee technical staff in the preparation of specimens for analysis, including the reception, processing, preservation, labelling, storage, distribution and disposal of products.
• To maintain accurate and legible written and electronic records in accordance with local data integrity policy.
• To operate, maintain and monitor clean rooms in accordance with
  HTA/MHRA/JACIE requirements.
• To assist in the recovery and infusion of cellular products.
• To respond, troubleshoot and problem solve in the event of laboratory equipment faults, procedural complications or alarm states. Offering immediate corrective actions and subsequently implementing any required change.
• To report faults and deviations to a senior member of staff and take prompt and appropriate action in response to unexpected situations, understanding when to escalate when limit or scope of practice is reached.
• To carry out laboratory diagnostic tests, validate results and use knowledge and judgement to determining and initiate further tests or actions that may be required.
• To provide advice, support and supervision to Technical staff and guest users of the facility.
• To liaise closely with clinical teams and QC testing laboratories to coordinate receipt of cells, product testing and re-infusions across multiple sites.
• To verify and relay critical information regarding donations and cellular products to the Newcastle Advanced Therapies team and service users which may have immediate impact on the management of the patient.
• To attend clinical areas (wards, theatres) on any of the trust sites to assist clinical staff in the delivery and administration of Cell, Gene and Tissue products.
• To be aware of the requirements from regulatory bodies applicable to the role (HTA, JACIE, MHRA) and perform all duties in accordance with the local Quality Assurance System to ensure regulatory compliance.
• To participate in clinical trial activities in accordance with GMP and GCP requirements.
• To participate in service and product improvement through continual education and training, taking an active role in policy, product and service development.
• To participate in the departmental audit, correct and record minor non-compliance (deviation) and immediately report any major deviations to a senior member of staff as per local policy.
• Take responsibility for own learning and development, maintaining a personal training record, ensuring all mandatory Trust and departmental training is performed in a timely manner.
• To work in compliance with local health and safety rules to ensure a safe working environment for you, colleagues and visitors. To adhere to department and Trust Health and Safety policies (including COSHH, Risk assessments and Standard Operating Procedures) and to report any deviations from protocol to a senior member of staff.