Production Scientist

Job Overview

Production Scientist (12 month maternity cover) position available in the Newcastle Advanced Therapies Team within the Pharmacy Directorate.

Main duties of the job

• To provide laboratory skill and expertise with an emphasis on specialist cell therapy processing including: CD34+ Selections, Red Cell Depletions and Mononuclear Cell Preparation, TCRαβ+ and CD19+ Depletions, CD45RA+ Depletions.
• 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.
• 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 determine 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.
• 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.

Person specification

• Qualifications & Education:
  • BSc in Scientific/Pharmaceutical subject or equivalent
  • HCPC registration or equivalent
• Knowledge & 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 & Abilities:
  • Computer literate
  • Skilled at workload planning and prioritisation
  • Excellent Communication skills
  • Ability to work as a team

Qualifications & Education

• BSc in Scientific/Pharmaceutical subject or equivalent
• HCPC registration or equivalent

Knowledge & 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 & Abilities

• Computer literate
• Skilled at workload planning and prioritisation
• Excellent Communication skills
• Ability to work as a team

Documents to download

• JD & PS (PDF, 287.8KB)
• Newcastle Staff Benefits (PDF, 274.4KB)