CDMO Product Development Technician
NorthStar Medical Radioisotopes
Summary
The CDMO Product Development Technician will provide support in NorthStar's radiologic science laboratories within the CDMO Product Development Department. Responsibilities include the ability to independently perform laboratory controls, maintenance and calibration of equipment, manifestation and disposal of radioactive material, preparation of laboratory solutions, support product development/production, and general laboratory maintenance. This role will specialize in development, verification, and validation of current and/or new radiopharmaceutical products.
Job description
Position
The CDMO Product Development Technician will provide support in NorthStar's radiologic science laboratories within the CDMO Product Development Department. Responsibilities include the ability to independently perform laboratory controls, maintenance and calibration of equipment, manifestation and disposal of radioactive material, preparation of laboratory solutions, support product development/production, and general laboratory maintenance. This role will specialize in development, verification, and validation of current and/or new radiopharmaceutical products.
Responsibilities
- Maintain and support specific laboratory controls including equipment calibration, radiologic assays, pharmaceutical compounding, solution preparation, inventory control, chromatography reagent preparation, and quality control testing.
- With appropriate supervision, perform routine and non-routine experiments and/or analyses following NorthStar procedures and guidelines. Ensure data is collected and documented according to good documentation practices.
- Perform tasks as needed to support product development. This may include solution preparation, equipment checks, and documentation preparation.
- Understand and execute the cradle-to-grave processes specific to all radioactive substances that are used in the laboratory including, but not limited to, DOT check in/check out process, waste management, and documentation/filing.
- Maintain low-level radioactive waste inventory management including: storage, manifestation, and disposal in accordance with regulatory requirements.
- Maintain supplies and manage inventory within the laboratory space.
Early Development
After 3 months you will:
- Be qualified to enter controlled spaces such as laboratories
- Trained on ALARA principles and RAD safety
- Be able to perform basic laboratory related calibrations
After 6 months you will:
- Independently run QC assays related to radiopharmaceutical preparation
- Independently support certain laboratory processes (e.g. inventory control, waste management, equipment calibration program)
Qualifications
Associate's degree in a related science discipline or related medical field or completion of an accredited Nuclear Medicine Technology educational program. Experience handling radioactive materials and operating radiation detection equipment preferred. Knowledge of ALARA principles required. Previous experience in a nuclear pharmacy, nuclear medicine department, laboratory setting, or cGMP environment preferred.
Requirements
- Associate's degree in a related science discipline or related medical field, or completion of an accredited Nuclear Medicine Technology educational program
- Knowledge of ALARA principles
- Experience handling radioactive materials
- Experience operating radiation detection equipment
- Previous experience in a nuclear pharmacy, nuclear medicine department, laboratory setting, or cGMP environment
Benefits
- Medical, Dental & Vision
- Healthcare & Dependent Care FSA
- Short & Long-Term Disability
- Life Insurance & AD&D
- Pet Insurance
- 401(k) Matching
- Paid Holidays & PTO
- Paid Parental Leave
- Bonus Plan
- Equity Incentive Program
Company overview
NorthStar Medical Radioisotopes, LLC is a commercial-stage nuclear medicine company headquartered in Beloit, Wisconsin, with additional facilities in Madison, Wisconsin. Founded in 2006, the company specializes in developing, producing, and manufacturing reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. NorthStar's mission is to provide patients global access to game-changing radiopharmaceuticals for cancer detection and treatment. The company is the first and only U.S. company housing commercial-scale radioisotope production and radiopharmaceutical CDMO services co-located on the same campus. NorthStar routinely produces therapeutic radioisotopes including copper-67 (Cu-67) and is poised to be one of the first commercial-scale producers of non-carrier-added actinium-225 (Ac-225) using innovative electron accelerator technology. Their FDA-approved diagnostic imaging product, technetium-99m (Tc-99m), is used in 40,000 patient imaging studies daily in the United States. The company also operates a Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO/CMO) unit that provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies advance their development and commercial programs.