Radiopharmaceutical Production Unit Site Manager

An opportunity has arisen for a Radiopharmaceutical Production Unit (RPU) Site Manager at Alliance Medical Diagnostic Imaging Ltd. Ireland.

This role will carry a high level of responsibility including involvement in the construction and commissioning of the first Alliance Medical RPU in Ireland.

The RPU will manufacture and distribute radiopharmaceutical products that meet industry-leading standards in quality, efficacy, and innovation.

Upon completion of the RPU, the Site Manager will have responsibility for the overall management of the site, line management, P&L, and the production and distribution of radiopharmaceuticals to PET imaging centres across Ireland.

Overall Role:

1. Work with Alliance Medical Radiopharma, the design and build team in the establishment of a fit for purpose RPU capable of meeting required production requirements.
2. Design, develop and operationalise all aspects of the RPU in line with all process and governance requirements and in line with regulatory compliance.
3. Manage all aspects of production and supply of Radiopharmaceutical products and be involved in future development & production of new Radiopharmaceutical products.
4. Ensure sufficient trained staff are available for the operation of cyclotron and production of radiopharmaceuticals.
5. Take responsibility for the RPU P&L.
6. Liaise with customers and suppliers as necessary to develop the business.
7. Ensure the site is adhering to current Good Manufacturing Practices (cGMP).

Duties and Responsibilities:Production

1. Manage operational activities for the manufacture of Radiopharmaceuticals products for the production synthesis of PET imaging products in strict adherence to GMP and relevant pharmacopoeia standards, ensuring high degree of supply reliability.
2. Ensure the management of raw material purchasing sampling, testing and release system are maintained in line with production requirements.
3. Responsible for the management of productive and streamlined processes ensuring that KPI's are met in line with RPU objectives.
4. Ensure that all customers receive a highly reliable, efficient, seamless, and high-quality service throughout the entire screening pathway.
5. Ensure up time of plant production equipment.
6. Responsible for developing and maintaining key performance indicator records for all aspects of production and distribution in accordance with GMP guidelines, safety and business needs.
7. Work with the QA team to co-ordinate and execute validation of GMP equipment and new product development.
8. Participate in the preparation and updating of Standard operating Procedures (SOPs) and Health & Safety (H&S) SOP's in accordance with the relevant guidelines as may be necessary from time to time for approval by the QP and adoption by the unit.

Staff

1. Responsible for the management of an engaged and motivated RPU team effectively utilising internal resources and supports including induction, buddy system, performance management, delegation, career development, One-to-ones and training.
2. Establish and maintain rotas for staff for all operational activities, absence (sickness and holidays), overtime, out of hours working plus maintenance and breakdowns.
3. Liaise with the Production Manager, Quality Control (QC) and Engineering Managers and be responsible for day-to-day supervision of staff to ensure manpower available to meet operational needs.
4. Training and development (including continued professional development) of staff to ensure staff perform their operational roles and to ensure ongoing personal development and best practice and ensure training records are maintained.
5. Assist in developing and implementing standard operating procedures and training plans for the team.

GMP Equipment Maintenance and Faults

1. Ensure detailed schedules of work are established and maintained for all production equipment.
2. Allocate work to staff and/or organise contractors to perform work.
3. Participate in supplier training courses to maintain and develop understanding of best practice.
4. To ensure management of stocks of spares and consumables for cyclotron, production and quality control equipment.
5. Organise systems for management of faults and repairs as required.
6. Ensure maintenance logs are maintained to aid troubleshooting, GMP requirements and for training of staff.
7. Maintain stocks of critical spares for the facility.

Quality Systems

1. Work with the Head of Quality to assist with the development, implementation and management of cGMP, and Quality Assurance systems and procedures for all aspects of radiopharmaceutical production.
2. Ensure compliance with radiation safety procedures and guidelines.
3. Work collaboratively with the Head of Quality to ensure full compliance with Quality Management Systems (QMS).
4. Strictly adhere to GMP, Good Laboratory Practice (GLP) and safety protocols laid down by the HPRA, EPA and Health & Safety Authority in accordance with issued licenses as determined from time to time.
5. Corresponding adherence to local rules developed to ensure conformity to such licensing requirement.
6. Ensure appropriate management of maintenance/engineering arrangements for reliable delivery of critical services including air handling, chilled water, gases, electric power and security to ensure high degree of uptime.

Production & QC Raw Materials and Consumables

1. Ensure appropriate management of stocks including policies, monitoring, ordering and recording for routine radiochemistry production including formulation of reagents, etc and the safe disposal of waste chemicals and materials.
2. Set up systems for policy levels and ensure stocks are replaced following use.

Skills in Radiochemistry

1. If qualified develop necessary skills to provide relief and rota support to production Radiochemist/s with specific reference to the functions of:
2. Operation of cyclotron to produce radioisotopes.
3. Manufacture of radiopharmaceutical tracers.
4. Dispensing of aseptic products.

Safety, Control and Security

1. Assume responsibility for the safe and efficient handling of all radioactive substances (solid, gas, liquid) received from the site's cyclotron including their synthesis, transmission, dispensing, storage, containerisation, packing, despatch, transport, decay control, and release. In accordance with local rules for emergency or serious incident procedure record such events in accordance with SOPs.
2. Responsible for management of agreed safety procedures to ensure safety of yourself and others.
3. Responsible for ensuring day to day site compliance with the Security Plan and to assist as required in any required activities such as site emergencies and planned exercises.

Management

1. Produce detailed monthly reports for financial and operational metrics for the board of Alliance Medical Radiopharmacy Limited (AMRL).
2. Produce timely annual budgets for AMRL.
3. Advocate on behalf of AMRL with customer groups throughout Ireland.

Minimum Requirements:

1. Degree or higher in relevant scientific/clinical/engineering (Engineering, Physics, Pharmacy, Clinical) area or equivalent experience.
2. A background in the manufacture of radiopharmaceuticals is desirable.
3. Previous managerial or supervisory experience with a demonstrable track record of strong performance.
4. Experience of developing successful customer relationships.
5. Experience of Quality Control in a radiopharmaceutical setting is desirable.
6. Demonstrated ability to build close working relationships with internal and external stakeholders and extensive experience of influencing decision making and ownership of initiatives.

Skills:

1. Excellent interpersonal skills & organisation skills.
2. Flexible – willingness to be actively involved in all elements of the role.
3. Leads by example.
4. Highly self-motivated.
5. Able to work on own; proactive including both defining and executing tasks.
6. A technical aptitude.

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