Research Lab Specialist - Radiochemistry University of Michigan - 4.3 Ann Arbor, MI Job Details Full-time 3 hours ago Benefits Health insurance Dental insurance Vision insurance Qualifications FDA submissions Regulatory inspections USP standards Medical writing Quality records maintenance Laboratory equipment routine checks Conference papers Pharmaceutical synthesis High-performance liquid chromatographs Presentations for conferences or internal meetings Publishing papers in peer-reviewed journals Routine inspections Mid-level Investigational new drug (IND) applications Corrective maintenance Bachelor's degree Doctor of Philosophy Laboratory quality control Batch records Laboratory preventive maintenance Automated systems Participating in conferences Regulatory submission editing and review Communication with regulatory authorities for clinical trials GMP for research safety and compliance Medical imaging Quality control records management Communication skills Under 1 year Laboratory compliance and regulatory documentation Full Job Description How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position. Mission Statement Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society. Job Summary The Division of Nuclear Medicine, Department of Radiology is currently seeking a Research Lab Specialist Intermediate position. The successful candidate will contribute in a variety of ways, consistent with her/his existing skills and previous experience in support of clinical and preclinical imaging studies, and quality assurance efforts. Responsibilities• Responsibilities include: Synthesis and quality control of PET tracers to meet demanding pre-clinical and clinical imaging schedules according to cGMP regulations (USP823 and 21 CFR212). Maintenance and upkeep of PET radiochemistry laboratory equipment such as automated synthesis modules and HPLCs. Accurate record keeping for lab books, equipment logbooks and production batch records. Assist with regulatory inspections and correspondence with regulatory agencies. Quality and regulatory compliance initiatives and routine monitoring/tracking/trending. Contribution to regulatory documents required for clinical PET tracer filings such as INDs and (A)NDAs. Presentation of research results at group meetings (and national meetings if interested). Assist with writing/co-authorship of manuscripts for submission to peer-reviewed journals. Collaborate with PET Center and imaging suite personnel to ensure we meet Michigan Medicine missions of excellence in research, clinical care, and teaching Required Qualifications•

Education and Experience:

Bachelor's degree and 1 to 3 years related experience; but can be substituted with equivalent education and/or experience. Excellent written and oral communication skills are a must. Excellent interpersonal skills and experience working in a highly collaborative working environment, including the ability to work remotely with teams in different locations. Ability to work independently A verifiable ability to function effectively in a continually changing environment, and to troubleshoot problems and implement corrective actions. Desired Qualifications• We are looking for a candidate with 1-3+ years of experience in PET radiochemistry or quality control/quality assurance, or PhD degree in (or equivalent) with 0-3+ years of experience in PET radiochemistry or quality control/quality assurance. Can be substituted with equivalent education and/or experience. Relevant research experience in PET radiochemistry is not required but would also be a plus. Hands on experience with the incorporation of fluorine-18, carbon-11 and gallium-68 is strongly preferred, including experience with the generation of radionuclides (from cyclotrons and/or gallium generators) and the synthesis, purification and quality control of PET radiotracers. Ability to troubleshoot in real time: e.g., during radiochemical syntheses, including chemistry issues and equipment malfunctions associated with the synthesis of PET radiotracers. A strong academic record including publications in peer reviewed journals would be a plus. Experience contributing to regulatory filings such as INDs and (A)NDAs. Why Join Michigan Medicine? Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good. What Benefits can you Look Forward to? Excellent medical, dental and vision coverage effective on your very first day 2:1 Match on retirement savings Modes of Work Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes. Work Schedule 5 days a week, M-F, 8 hrs/day (40 hrs/week) Shifts start as early as 6:00 AM. Work Locations Medical Science I Building Background Screening Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses. Application Deadline Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended. U-M EEO Statement The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities. Job Opening

ID 281977

Working Title Research Lab Specialist - Radiochemistry Job Title Research Lab Specialist Inter Work Location Ann Arbor Campus Ann Arbor, MI Modes of Work Onsite Full/Part Time Full-Time Regular/Temporary Regular FLSA Status Exempt Organizational Group Medical School Department MM Department of Radiology Posting Begin/End Date 8/19/2026 - 10/18/2026 Career Interest Radiology Research