Apply on Employer Site

NorthStar Medical Radioisotopes, LLC · 2 months ago

Senior Microbiologist, Product Development

Beloit, WI

Full-time

Onsite

Senior Level

5+ years exp

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. The Senior Microbiologist will drive the microbial validation strategy and collaborate on microbiological development projects, ensuring compliance with FDA standards.

Health CareHealth DiagnosticsHospitalityManufacturingPharmaceuticalTherapeutics

No H1B

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

Qualification

Microbial validation strategyMicrobiological development projectsLaboratory PracticePharmaceutical industry experienceRadiopharmaceuticals experienceLab controls knowledgeMaster's in biological scienceSoft skills