Radioisotope Production Specialist III/IV
Required skills
- Chemistry
- Biochemistry
- Chemical Engineering
- Radioactive material
- Routine production environment
- cGMP regulated work
- Analytical skills
- Problem-solving skills
- Radiation safety
- Safety procedures
Nice to have
- Project management skills
- KPIs
- Quality
- Safety
- Productivity
- Continuous improvement
Role summary
We are seeking a Radioisotope Production Specialist III/IV to join our team dedicated to developing medical isotopes for cancer treatment. This role involves executing the production of medical radioisotope products, maintaining cGMP compliance, and implementing production methods. Responsibilities include raw material preparation, equipment setup, record keeping, and cold chemistry preparation. The ideal candidate has a Bachelor's degree in a science/engineering field, 3+ years of experience with radioactive material, routine production, and cGMP environments, along with strong analytical and problem-solving skills. Experience in a chemical laboratory is essential. Preferred qualifications include team leadership and mentoring experience.
- Executes production of medical radioisotope products (including raw material preparation, line clearance and cleaning equipment/instrument setup, etc.).
- Maintains compliance with cGMP practices; participating in quality training and event retrospectives.
- Implements production methods and product formulation to resolve problems and accomplish specific objectives.
- Operates at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Participates in periodic reviews of component labor routing, material requirements, and manufacturing procedures.
- Participates in new product / process transfers and validations.
- Contributes to inventory management, including cleaning supplies and personal protective equipment (PPE).
- Demonstrates accountability of self in following radiation and general safety procedures and promotes a culture of safety by helping others to do the same.
- Maintains records in a comprehensive, reproducible, and accurate manner.
- Cold chemistry preparation including making solutions, columns, compounds, etc.
- Commission new equipment with radioactive and non-radioactive chemistry.
- Bachelor degree in science/engineering field or equivalent education/experience
- Chemistry, biochemistry, chemical engineering or related field
- Experience in a chemical laboratory
- 3+ years’ experience working with the following:
- Radioactive material
- Ongoing/routine production environment
- cGMP regulated work
- 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.
- Organizational and project management skills for self and teams.
- Regularly engages in mentoring multiple team members in all aspects of production roles and provides mentoring and recommendation for those pursuing the technical mentor track.
- RPS IV candidates must meet the additional requirements to:
- Lead production shift operations with a small team
- Execute on (Key Performance Indicators) KPIs, communicate key program updates, and drive improvements in quality, safety, and productivity to ensure KPIs are met.
- Within the department and across the organization, foster a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization.
- Shift work includes evening, night, and early morning shifts, as well as fixed or rotating schedules
- Standing and sitting for prolonged periods of time
- Lift and move up to 25 lbs.
- Wear safety glasses, goggle, gloves, lab coat, and/or Tyvek suit
- Required to handle & work with radioactive material most of the time
- Work in Glovebox Lab Environment for up to 8 hours
- Handle chemicals and solutions
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
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