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NorthStar Medical Radioisotopes

Produces diagnostic and therapeutic radiopharmaceuticals.

Radiopharmaceutical Development Scientist

Bioprocess & BiomanufacturingPosted on Nov 13
Full-timeBeloit, WI, USAIn-person

About the Job

Requirements

  • A bachelor's degree in chemistry or related life sciences and at least six years of experience handling radiopharmaceuticals; or a master's degree in chemistry or related life sciences and at least four years of such experience; or a PharmD or PhD in chemistry or related life sciences and at least two years of such experience.
  • Preferred education and experience include a PharmD or advanced degree in chemistry or related life sciences and at least five years of experience handling radiopharmaceuticals.
  • Previous experience with analytical methods such as high-performance liquid chromatography (HPLC), gas chromatography (GC), thin-layer chromatography (TLC), and gamma spectrometry is preferred.
  • A Board Certified Nuclear Pharmacist (BCNP) credential is preferred.
  • Maintain professional certifications according to licensure requirements.
  • Obtain Authorized User of radioactive materials certification within six months of hire.
  • Work in controlled cleanroom, office, or manufacturing areas; comply with personal protective equipment and cleanroom gowning protocols, including restrictions on jewelry, cosmetics, fragrances, and nail products.
  • Follow radiation safety procedures and participate in dosimetry monitoring and bioassay testing.
  • Inform leadership of any health conditions that may affect product integrity under cleanroom standards.

Responsibilities

  • Support CDMO product development and related projects, including radiopharmaceutical drug and method development, formulation testing, technology transfer, and cGMP manufacturing.
  • Perform radiolabeling, quality control testing and development, laboratory controls, design of experiments, cross-training, and associated documentation.
  • Participate directly with customers to understand and provide contract development services that meet company objectives and timelines for CDMO product development and manufacturing.
  • Demonstrate expertise in radiolabeling and manufacturing.
  • Develop, perform, interpret, and document design of experiments to support analytical, data-driven decisions for production of novel radiopharmaceuticals.
  • Independently use laboratory instrumentation required for CDMO product development operations.
  • Collaborate with internal and external customers to provide solutions supporting CDMO development and operations.
  • Stay current with scientific literature related to radiopharmaceutical therapies, cGMP production, and regulations.
  • Participate in and lead efforts to onboard, calibrate, maintain, and troubleshoot laboratory equipment.
  • Oversee employees in radiation laboratories and assist with training.
  • Complete training to enter controlled laboratory spaces, use essential analytical equipment and radiolabeling and quality control procedures, and operate drug products in and near production readiness.
  • Learn procedures pertaining to radiolabeling and quality control, the workflow from product and method development through technology transfer and clinical manufacturing, and BE5 workflow and operations; gain at least 50 hours of experience handling alpha, beta, and gamma isotopes.
  • Work in controlled cleanroom, office, or manufacturing areas, potentially with varying temperatures and noise levels.

Desired Qualifications

  • A PharmD or advanced degree in chemistry or related life sciences, together with at least five years of experience handling radiopharmaceuticals.
  • Previous experience with analytical methods such as high-performance liquid chromatography (HPLC), gas chromatography (GC), thin-layer chromatography (TLC), and gamma spectrometry.
  • A Board Certified Nuclear Pharmacist (BCNP) credential.

About the Company

NorthStar Medical Radioisotopes

Produces diagnostic and therapeutic radiopharmaceuticals.

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Company size
201-500
Company stage
Debt Financing
Total funding
$302.5M
Headquarters
Madison, WI
Founded
2006

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