AMVETS Jobs

Job Title: QUALITY CONTROL (QC) CHEMIST Reports to: Director, Quality Classification: Full Time, Exempt Work Location: Rochester, MN - onsite ABOUT NUCLEUS RADIOPHARMA: Founded by Mayo Clinic and Eclipse Ventures, Nucleus RadioPharma is a Contract Manufacturing and Development Organization built to ensure patients can access potentially life-saving radiopharmaceuticals through technologies to modernize the clinical development, manufacturing, and supply chain of these promising new treatment tools. POSITION SUMMARY: The Quality Control (QC) Chemist will play a key role in the execution of QC analytical methods and assist in the supervision of a highly effective QC team to support radiopharmaceutical drug production. PRINCIPAL RESPONSIBILITIES: Supports the development and leads the execution of QC methods for radioactive drug products in a GxP environment, including radio-HPLC, TLC, GC, gamma spectroscopy, endotoxins, pH, etc. Assists in supervision of the QC Chemistry team which includes training, coaching, and offering performance and development management. Provides support and assistance for laboratory personnel in daily activities to fulfill client and GMP requirements. Responsible for training QC Techs on cGMP guidelines 21 CFR 210, 211, 212 (as applicable). Responsible for training QC Techs in analytical and QC testing methods. Serves as Subject Matter Expert for Quality Control testing on site. Collaborate with other groups within the facility to understand goals and communicate changes throughout the organization. Provide input for strategic planning for new product lines. Work closely with scientific staff to evaluate technical feasibility of new products. Maintain QC budget and responsible for communicating QC laboratory staffing and budget needs. Writes, maintains and updates necessary Standard Operating Procedures (SOPs), Validation Protocols and Validation Report. Performs other duties as assigned.