- Ensures that JDI maintains an effective level of operations staffing in order to meet internal and external client demands, while meeting all regulatory requirements.
- Ensure that the operations staff is equipped with sufficient equipment to execute their tasks in a safe and efficient manner.
- The development and implementation of quality improvement plans to meet appropriate existing regulatory guidelines (including HPFB, FDA and EMEA) and to anticipate / take appropriate measures to meet future regulatory guidelines.
- Responsible for maintaining the manufacturing and QC laboratories, the general JDI facilities and to ensure that all equipment contained within these facilities complies with cGMP standards. Said equipment must also be designed with the company’s goal to keep radiation doses as low as reasonably possible (ALARA).
- The development of the annual and long-range operating budgets with respect to manufacturing operations and management of the budget throughout the year. Assist with the development and implementation of the site capital budget.
- Maintenance of a formal continuous improvement program and KPI dashboard.
- Assist in the design/purchase of new equipment for use within radiopharmaceutical plant.
- Responsible for the oversight of re-formulation and process improvement activities for existing products.
- Responsible for working with Research and Development, Engineering and Validation teams to ensure the seamless transition of new projects to the Production Department.
- Evaluate new proposed products or projects in order to determine the viability of these for JDI.
- Effectively manage related labor force/union relationships.
- Working with Radiation Safety Officer to maintain ALARA principle within department.
- Act as a back-up for the Manger. Manufacturing Operations, Manager, Engineering and Maintenance and Supervisor, Validation as necessary.
- Oversee all Supply Chain activities including Raw Material procurement and external contract manufacturing.
- Responsible to assist in the development and to oversee the execution of all Business Excellence projects at JDI.
·Active member of Executive committee, Quality Council and Radiation Safety Committee.
- Bachelor’s degree in Science or related major. MBA is an asset.
- A proven track record within a recognized Pharmaceutical production environment (10 years minimum) with at least 3 years exposure to the manufacture of radiopharmaceutical products.
- Strong understanding of cGMP (both FDA and HPFB) regulations.
- Excellent leadership and team development skills.
- Knowledge of the principles of radiopharmaceutical chemistry and manufacturing.
- Ability to foster a positive employee relations environment. Excellent communication and interpersonal skills.
- Results driven and exposure to a customer service culture is desirable.
- Excellent relationship management and negotiations skills.
- Bilingual (English/French).