JOB DESCRIPTION
Summary/objective
The Radioisotope Production Supervisor role encompasses team leadership, operational excellence, and fosters a culture of safety, quality, and continuous improvement.
This position will manage capabilities focusing on scale-up of various radioisotope process, operational excellence, delivery of high quality isotopes, technical transfer of lanthanide separation and recovery technology, and operation of separation, purification and fill-finish procedures following cGMP. This position will lead the medical isotopes team, including day-to-day oversight of manufacturing, supply chain, logistics, safety and quality.
Essential Functions:
Production Management
• Lead all operational efforts and identify process improvements to increase efficiencies and support strategic growth.
• Develop, implement, and oversee process workflows, production operations, schedules, staffing levels, and equipment utilization for medical isotopes to ensure the required production output is achieved.
• Oversees production of medical radioisotope products (including raw material preparation, line clearance, cleaning equipment/instrument setup, etc.).
• Maintains compliance with cGMP practices, policies and procedures.
• Coordinates with key stakeholders in the organization to ensure production objectives are met and staff are properly developed and trained.
• Collaborate effectively with a cross functional team, including Facilities, Engineering, QA and QC to integrate medical isotope operations to meet objectives and complete key initiatives.
• Set KPIs for isotope manufacturing, communicate key program updates, and drive improvements in quality, safety, and productivity to ensure KPIs are met.
• Interact and maintain strong collaborative relationships with stakeholders including business partners, industry partners, and service providers.
• Demonstrate strategic planning skills, strong leadership skills, effective communication skills, high level of drive, integrity and energy.
• Liaise with Niowave partners (current and potential) to develop and meet product specifications, quantities, and timeline of deliveries.
• Support efforts to maintain quality requirements for various certifications (cGMP, ISO1345:2016)
Working Title
Radioisotope Production Supervisor
Market Title
Reports To
Director/Manager of Radioisotope Production
FLSA Classification
Salary/Exempt (Full Time)
Team Management
o Leads and inspires a diverse team of skilled professionals.
o Establishes and maintains a technical direction and supervisory oversight structure for the department, including career progression and succession planning.
o Hires, fires, promotes, disciplines, coaches, and awards staff members according to organizational policies.
o Holds consistent coaching sessions through 1:1's and career development meetings.
o Ensures the onboarding, training, and career development of staff members.
o Within the department and across the organization, fosters a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization.
Competencies
• Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills.
• Models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal.
• Understands how to integrate into a new team/organization - appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.
• Understands their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two.
Required Education and Experience
• Bachelor's degree in Chemistry, Chemical Engineering or related field
• 5 years' experience operating in a cGMP manufacturing environment
• At least 3 years' experience supervising day to day activities of other team members, providing mentoring, and career development coaching
Preferred Education and Experience
• Masters degree in Chemistry, Chemical Engineering or related field
• Experience with radiochemistry and/or radiopharmaceuticals strongly preferred.
• Experience with chromatography separation, liquid/solid extraction, electrochemistry or amalgamation/cementation processes is an asset
• Hands-on experience utilizing lean manufacturing principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S)
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk and hear; wear safety glasses, goggles, gloves, lab coat, and/or Tyvek suit; work in a glovebox lab environment; handle chemicals, solutions, and/or radioactive materials. The employee must occasionally lift or move products and supplies, up to 25 pounds.
Position Type/Expected Hours of Work/Travel
• Full-time position.
• Company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position is a part of shift work including nights, weekends, and holidays.
• Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Other duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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