Radioisotope Production Specialist I/II
Required skills
- Radioisotope Production
- cGMP
- Radioactive Material
- Chemical Laboratory
- Production Environment
- Safety Procedures
- Record Keeping
- STEM
- Associate's degree
- STEM field
Nice to have
- Biochemistry
- Chemical Engineering
- Process Validation
- New Product/Process Transfers
- Labor Routing
- Material Requirements
Role summary
We are seeking a Radioisotope Production Specialist to join our team dedicated to developing medical isotopes for cancer treatment. This role is crucial in the production and global shipment of these life-saving products. You will be responsible for executing production processes, maintaining cGMP compliance, preparing materials, operating equipment, and ensuring safety and accuracy in all operations. The ideal candidate is detail-oriented, efficient, and thrives in a standardized, precise work environment. Experience with radioactive materials, cGMP regulations, and chemical laboratory operations is highly desired, with 1-2 years of experience in a routine production environment preferred.
- 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.
- Associate’s degree or equivalent experience
- Courses/degree in STEM field (science, technology, engineering, mathematics)
- Chemistry, biochemistry, chemical engineering or related field desired
- 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.
- Bachelor degree in science/engineering field or equivalent experience
- Chemistry, biochemistry, chemical engineering or related field
- Experience working with radioactive material
- Knowledgeable in cGMP regulations
- Experience in a chemical laboratory or related field
- 1 - 2 years’ experience working with the following:
- Radioactive material
- Ongoing/routine production environment
- cGMP regulated work
- 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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