Summary

The Radiopharmaceutical Development Scientist will support both CDMO product development and related projects. Specifically, the candidate will oversee activities related to radiopharmaceutical drug and method development, formulation testing, technology transfer, and cGMP manufacturing. This includes but is not limited to radiolabeling, quality control testing and development, laboratory controls, conducting design of experiments, cross-training, and authoring of associated documentation. This individual will participate directly with customers to understand and provide contract development services to meet company objectives and timelines in support of CDMO product development and manufacturing.

Job description

Position

The Radiopharmaceutical Development Scientist will support both CDMO product development and related projects. Specifically, the candidate will oversee activities related to radiopharmaceutical drug and method development, formulation testing, technology transfer, and cGMP manufacturing. This includes but is not limited to radiolabeling, quality control testing and development, laboratory controls, conducting design of experiments, cross-training, and authoring of associated documentation. This individual will participate directly with customers to understand and provide contract development services to meet company objectives and timelines in support of CDMO product development and manufacturing.

Responsibilities

Demonstrate expertise in the area of radiolabeling and manufacturing.
Develop, perform, interpret, and document (DOE) design of experiments in order to facilitate analytical data driven decisions for production of novel radiopharmaceuticals.
Independently use all laboratory instrumentation required for CDMO product development operations.
Collaborate with internal and external customers to provide solutions in support of CDMO development and operations.
Stay current with the latest scientific literature as related to radiopharmaceutical therapies, cGMP production, and regulations.
Participate and lead efforts to on-board, calibrate, maintain, and troubleshoot laboratory equipment.
Oversee employees in radiation laboratories and assist in training.

Early Development

After 3 months you will: Be qualified to enter controlled spaces such as laboratories; Be trained on essential analytical equipment and procedures pertaining to radiolabeling and QC; Complete Operator training for drug products in and near production readiness.

After 6 months you will: Be trained on all procedures pertaining to radiolabeling and QC; Understand the workflow from product and method development to tech transfer and clinical manufacturing; Have a minimum of 50 hours of experience handling alpha, beta, and gamma isotopes; Have a complete understanding of BE5 workflow and operations.

Requirements

Bachelor's degree in chemistry or related life sciences with a minimum of six (6) years of experience in handling radiopharmaceuticals
Master's degree in Chemistry or related life sciences with a minimum of four (4) years of experience in handling radiopharmaceuticals
PharmD or PhD in chemistry or related life sciences with a minimum of two (2) years of experience in handling radiopharmaceuticals
Authorized User of radioactive materials certification required within 6 months of hire
Expertise in radiolabeling and manufacturing
Experience with analytical methods such as HPLC, GC, TLC, and gamma spectrometry
Board Certified Nuclear Pharmacist (BCNP) credential preferred
Maintain professional certifications per licensure requirements

Benefits

Medical, Dental & Vision
Healthcare FSA
Dependent Care FSA
Short-term Disability
Long-term Disability
Life Insurance
AD&D Coverage
Pet Insurance
401(k) Matching
Paid Holidays
Paid Time Off
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.