Radiopharmacy Technician Newcastle

Curium Pharma; Newcastle upon Tyne; On-site; GBP 52,000 - 82,000; Full time

Benefits offered by this job

Competitive compensation package

Pension Plan Scheme contribution

Private Medical Insurance

Job summary

Curium Pharma in Newcastle upon Tyne seeks a GMP-compliant radiopharmacy professional to support PET radiopharmaceutical production, QC, and aseptic dispensing. The role involves drafting SOPs and validation protocols, and maintaining GMP documentation for quality assurance.

The candidate will operate hot cell and isolator equipment, conduct environmental and radiochemical testing, and participate in staff training and CAPA processes. Newcastle site requires flexibility for rotating shifts.

Qualifications

• Degree in a scientific discipline; GMP environment experience preferred.
• GMP experience and knowledge of radiopharmaceutical production are required.
• Ability to work rotating 12-hour shifts (00:00–17:00).
• Experience with aseptic dispensing or radiopharmacy is desirable.
• Strong documentation and record-keeping skills.

Responsibilities

• Manufacture PET radiopharmaceuticals in hot cell and isolator environments.
• Clean and sanitise aseptic suite facilities and conduct aseptic dispensing.
• Maintain GMP documentation, logs and records for QA purposes.
• Perform quality control analyses of radiopharmaceuticals per European Pharmacopoeia.
• Train technicians and support CAPA and root-cause analysis activities.
• Operate or maintain GMP lab equipment and perform environmental monitoring.

Skills

GMP experience

Radiopharmacy

Environmental monitoring

Documentation

Quality control

CAPA / Root Cause Analysis

Staff training

Equipment maintenance

Computer literacy

Education

BSc in Chemistry or related field

Tools

Hot cell equipment

Dispensing database

Environmental monitoring equipment

Job description

The post holder will be involved from the early stages of the project which will involve drafting documentation including SOPs and validation protocols for review. Executing validation protocols for the production and quality control of radiopharmaceutical products. Upon completion of the project the post holder will participate in the GMP production, sterile and aseptic dispensing, and quality control of PET radiotracers for clinical use. Operating a range of automated and manual radiochemical synthesis and quality control equipment. The role also involves assisting in all aspects of operating and maintain the facility to GMP standards, including documentation, equipment and laboratory maintenance including cleaning, environmental monitoring, incoming materials management, and stock control.

The position is located at Newcastle.

Job description:

Summary of Position

The post holder will be involved from the early stages of the project which will involve drafting documentation including SOPs and validation protocols for review. Executing validation protocols for the production and quality control of radiopharmaceutical products. Upon completion of the project the post holder will participate in the GMP production, sterile and aseptic dispensing, and quality control of PET radiotracers for clinical use. Operating a range of automated and manual radiochemical synthesis and quality control equipment. The role also involves assisting in all aspects of operating and maintain the facility to GMP standards, including documentation, equipment and laboratory maintenance including cleaning, environmental monitoring, incoming materials management, and stock control.

Essential Functions:

• Manufacture PET radiopharmaceuticals using hot cell and isolators;
• Sanitisation/cleaning aseptic suite facilities;
• Aseptic dispensing of PET radiopharmaceuticals using negative pressure isolator technology;
• Adopting radiation protection technique at all times ALARA;
• Packing and dispatch of radiopharmaceuticals according to local guidelines and transport regulations;
• Collating received orders and inputting them into the dispensing database;
• To carry out staff training and knowledge sharing when applicable;
• Sanitation and transferring of consumables in the aseptic suite and isolators;
• Cleaning the isolators and Radiopharmacy facility according to SOP’s;
• Aseptic Suite monitoring including Environmental monitoring, Radiations monitoring;
• First line maintenance of equipment;
• Carry out Quality Control procedures analysing the radionuclide and radiochemical purity of radiopharmaceuticals using standard analysis packages as specified in the European Pharmacopoeia;
• Undertake laboratory cleaning, maintenance and procedures required for GMP analysis of radiopharmaceuticals;
• Recording of the logs for fridge, freezers, isolator checks and all other logs;
• Raising and completing deviation reports where applicable;
• Participate in Root Cause Analysis and CAPA identification;
• Effective communication with all colleagues to facilitate efficiency in both production and quality related matters;
• Maintain paper and electronic records from all production processes for statutory purposes, including production and quality control under GMP;
• Assist in qualification/requalification exercise as required including preparing documentation and execution of protocols;
• Setting up production orders in the system, Checking stock level and ordering products;
• Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues;
• Comply with the requirements of the Pharmaceutical Good Manufacturing Practice (GMP), Ionising Radiation Local Rules, COSSH and Health & Safety procedure;
• Training of Technicians in PET manufacturing and QC processes, and standard operating procedures across the site.

Requirements:

• Degree in a scientific discipline (e.g., Chemistry, Pharmaceutical Sciences, Biology, Biomedical Science, Radiochemistry, or a related field);
• Knowledge of working within a GMP environment;
• Willingness to work flexibly on a rotating 12 hour shift pattern between 00:00 (midnight) to 17:00;
• Knowledge of Ionising Radiation Local Rules, COSSH and Health & Safety procedure (Desirable);
• Validation experience (Desirable);
• Aseptic dispensing or Radiopharmacy experience (Desirable);
• Working knowledge of pharmaceutical chemistry and good manufacturing practice is required;
• Ability to work independently and use own initiative;
• Strong communication and interpersonal skills;
• Excellent time management and organizational skills;
• Ability to work effectively under pressure;
• Excellent attention to detail and high level of computer literacy.

What we can offer you:

• Competitive compensation package;
• Pension Plan Scheme contribution;
• Private Medical Insurance Premium Program;
• Employee Assistance Program – A 24 Hour Free Confidential Helpline is availble to support Employees through any of life´s issues or problems;
• Cycle to Work Scheme – Employees can join this benefit and hire bike and/ or cycling accessories for commuting. The initial payment is done by Curium and the costs are deducted in 12 months against the Employee´s gross salary which makes savings through a tax break;
• Referral bonus.