Supervisor - Radiopharmaceutical Manufacturing

1w1 week ago

NorthStar Medical Radioisotopes

Beloit, US · Full-time · $85,000 – $115,000

About this role

Join the best radiopharmaceutical company in the world. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. Scientific excellence drives innovation using first-in-kind electron accelerator technology.

The Supervisor, Radiopharmaceutical Manufacturing leads daily production activities, ensuring compliance with all regulatory standards, safety standards, and company policies. This role delivers clinical and commercial client batches per schedule and contract obligations. It maintains the integrity and safety of the manufacturing environment for successful product delivery.

Lead and mentor a team, efficiently allocate resources, and continuously enhance production processes to optimize operational efficiency. Provide leadership, training, and support while monitoring quality assurance procedures and key operational metrics. Address issues related to equipment, processes, or personnel with proper communication and escalation.

Work in a rapidly growing organization on the cutting edge of science with world-class facilities. Enjoy exceptional career growth and professional development opportunities. Advance life-saving radiopharmaceutical development and ensure a reliable supply of critical medical isotopes.

Requirements

Associate’s Degree (AS) in a STEM discipline
Minimum four (4) years of cGMP experience or equivalent combination of education and experience
Minimum one (1) year of experience leading others
Knowledge of regulatory standards and safety protocols in radiopharmaceutical manufacturing
Experience ensuring compliance in clinical and commercial batch production
Familiarity with batch production records and quality assurance procedures
Ability to monitor operational metrics and resolve manufacturing issues

Responsibilities

Manage the day-to-day activities and personnel to ensure efficient manufacturing of products to meet the master production schedule ensuring compliance with regulatory requirements while maintaining high safety standards
Provide leadership, training, and support to the team and ensure performance and training requirements are achieved
Monitor and enforce strict quality assurance procedures and key operational metrics to meet product specifications
Address and resolve issues related to equipment, processes, or personnel in a timely manner with proper communication and escalation
Effectively communicate with manufacturing support groups on product specifications, escalations, and delivery schedules while updating management on production status
Ensure complete and accurate records are maintained for Radiopharmaceutical Manufacturing Batch Production Records according to orders
Assist in maintaining the department’s budget by monitoring monthly production expenditures and efficient resource allocation
Collaborate with manufacturing support teams to allocate resources and support technology transfer and process scale-ups