The Sylvia Fedoruk Canadian Centre for Nuclear Innovation (Fedoruk Centre) aims to place Saskatchewan among global leaders in nuclear research, development and training through investment in partnerships with academia and industry for maximum societal and economic benefit. As part of its mandate, the Fedoruk Centre is responsible for regulatory commissioning and on-going operation of a new radioisotope production facility owned by the University of Saskatchewan and located in Saskatoon, Saskatchewan. The facility, which includes a high-current ACSI TR24 cyclotron and a cGMP laboratory, is dedicated to research, training, innovation and production of molecular imaging probes and associated technologies.
The Fedoruk Centre is seeking outstanding applicants for a Facility Leader.
Primary Purpose: The Facility Leader is responsible for the overall management of the radioisotope production facility including production, synthesis of radiopharmaceuticals, researcher access program and business activity.
Nature of Work: The Facility Leader is responsible for ensuring secure production of isotopes and synthesis of radiopharmaceuticals for use in research and medical care and manages all aspects of the facility’s business including safety, financial, human resources, regulatory compliance, radiation safety, and support of researchers and industry partners.
To achieve the objectives of the facility, the Facility Leader reports to the Executive Director, works closely with the Fedoruk Centre management team, leads a small technical team (4 to 6 people) and works with external advisory committees. Development of effective relationships with researchers, industry partners and stakeholders is integral to success in this position.
The primary work environment is a new radioisotope production facility, consisting of a cyclotron and a cGMP radiopharmaceutical laboratory including hot cells, auto-synthesis units and a quality control system (HPLC, GC, TLC) and a suite of offices. The facility occupies 1400 sq meters in a newly renovated building; the remainder (600 sq meters) of which is managed by the University of Saskatchewan in support of related research activities. The facility operates in compliance with Canadian Nuclear Safety Commission (CNSC) regulations for a class II nuclear facility, Health Canada cGMP and all provincial, federal and internal quality, safety and regulatory requirements. All technical personnel are trained as Nuclear Energy Workers (NEW). While there is exposure to ionizing radiation and potential exposure to radioactive materials in parts of the facility, the radiation exposure per individual personnel is monitored and controlled in compliance with regulatory guidelines.
Depending on priorities for duties and deliverables, work hours outside of the standard work week will be required. Occasional travel within the university, province or elsewhere may be required.
The Fedoruk Centre is potentially subject to criticism by some of its community of participants or in media stories. High quality work, an exceptional safety record, compliance with regulatory requirements and cost efficiency will be essential to mitigating reputational risks for the Fedoruk Centre.
- Safety of employees, clients, stakeholders and the general public.
- Compliance with regulatory and safety requirements including CNSC, Health Canada, Federal and Provincial Labour codes, standard operating procedures and internal quality and safety standards.
- Oversight of all aspects of production with a focus on operational and product safety.
- Quality assurance of radiopharmaceuticals produced in the facility ensuring product safety and that regulatory requirements are met.
- Development and implementation of business plans to ensure long-term growth and sustainability of the facility.
- Budget development and day-to-day financial management.
- Staffing of the facility to meet facility objectives.
- Meeting reporting requirements to stakeholders and regulatory bodies.
- Access program for academic and industry researchers.
- Develop and maintain effective partnerships with academic and industry clients.
- Education: A recognized undergraduate degree or equivalent experience in business or financial management and a recognized undergraduate degree or equivalent experience in a relevant technical area preferably in radiopharmacy, pharmacy, chemistry, biochemistry, nuclear physics or nuclear medicine. An MBA would be considered an asset.
- Experience: Seven years of experience managing business and production in a technological facility operating in a highly regulated environment, preferably a cGMP production facility. Experience with CNSC and Health Canada regulations governing the operation of a nuclear facility and pharmaceutical production would be considered an asset.
- Skills and knowledge:
- Thorough knowledge of cGMP for pharmaceutical production and quality assurance;
- Working knowledge of the Canadian radioisotope market;
- Understanding of cyclotron technology and associated equipment (synthesis units, hot cells, etc.) and applications of radioisotopes in research and health care;
- Proven ability to develop and implement sound business plans based on market and environmental indicators and to manage operations including production, deployment of resources and monitoring progress towards financial and operational objectives;
- A high level of professionalism demonstrated by an ability to communicate effectively and to develop and maintain respectful and collaborative relationships with a wide variety of individuals including team members, academic and industry researchers, service providers and stakeholders; and
- An ability to reflect, clarify, and commit to what is important, take responsibility for growth and development, and contribute to positive and productive work and learning environments.
Salary Information: The salary range is $110,000 to $135,000 per annum plus a competitive benefits package including health and dental coverage and pension. The starting salary will be commensurate with education and experience.
How to apply: Submit a covering letter and curriculum vitae in PDF format (maximum 150KB each) by email to firstname.lastname@example.org. Subject Line: Facility Leader; [your name]
Screening of applications is expected to begin by September 21, 2014. Applications will be accepted until the position is filled.
Inquiries regarding this position may be directed to:
The University of Saskatchewan is strongly committed to a diverse and inclusive workplace that empowers all employees to reach their full potential. All members of the university community share a responsibility for developing and maintaining an environment in which differences are valued and inclusiveness is practiced. The university welcomes applications from those who will contribute to the diversity of our community. All qualified candidates are encouraged to apply; however, Canadian citizens and permanent residents will be given priority.