Senior Microbiologist, Product Development

NorthStar Medical Radioisotopes•Beloit, WI

About The Position

Join the best radiopharmaceutical company in the world! If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At the forefront of NorthStar’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package. Position The Senior Microbiologist, Product Development will be a technical leader, bringing the science of microbiology in a pharmaceutical application to the development and maintenance of equipment, cleanrooms, and processes used in the manufacture of radioisotopes. This includes gathering technical information about engineering system/set up and managing the implementation of novel radioisotope manufacturing technologies. The Senior QAPD Microbiologist will develop and execute microbiological methods and validations from concept phase through design, planning, and execution, as well as coordinating with other departments. This person is also responsible for working with cross functional teams, including RA/QA and Engineering, to apply efficient cGMP processes, to preserve data integrity and quality of the drug product, and to ensure the safety of all production and non-production personnel.

Requirements

Master’s Degree in biological science and five (5) or more years of experience in the pharmaceutical/medical device industry or equivalent combination of education and experience.
Experience developing clear, concise, and adequate protocols, procedures, and work instructions required.
Must possess a working knowledge of lab controls and general scientific equipment and should strictly adhere to written procedures and enforce it in others.

Nice To Haves

Master’s degree in microbiology preferred.
Experience with Radiopharmaceuticals would be a strong asset in this position.

Responsibilities

Drive the development of overall microbial validation strategy for pharmaceutical application to development of equipment used in the delivery of radioisotopes . This would include developing and executing methods and validations from concept phase through design, planning, and execution as well as coaching other team members.
Assist lab management. Be the primary point of contact for microbiology laboratory supplies, instrumentation, and environmental monitoring program activities.
Develop, plan, implement, and support microbiological development projects in collaboration with cross-functional teams with an overall focus on microbiological safety.
Maintain laboratory procedures in accordance with Good Laboratory/Manufacturing Practice standards of the US FDA, 21 CFR Part 210 & 211
Follow good laboratory practice, good documentation, and good manufacturing practice when creating and executing advanced protocols to verify and/or validate product conformance in the area of microbiological testing and control.