Hiring: Manufacturing Specialist Company: Nucleus RadioPharma Location: Rochester, MN Job Posted Time: 2026-09-10 07:42:10 Employment Type: Contract Target Skills & Keywords : Assembly, R About the job Experience: •2 years of relevant experience working in an FDA CGMP regulated environment with 21 CFR Parts 210 and 211 required. •Minimum 2 years of relevant experience working in an FDA CGMP regulated environment with 21 CFR Parts 210 and 211 required. Required Skills: •Leads and supports other team members in a fast-paced manufacturing environment and setting, to include backing manufacturing goals, standards, mindsets, and behaviors both on and off the manufacturing floor. •Ensures strict adherence to quality, safety, regulatory guidance, and written procedures in the manufacturing of final drug products in accordance with CFR (CGMP) guidelines, FDA, OSHA, and MN DHS. •Performs routine cleaning of the manufacturing areas, setting up manufacturing equipment, performing daily checks on various manufacturing equipment, and operating of equipment in accordance with CGMP, SOPs, and aseptic technique. •Follows all written procedures, verbal instructions, and communicates effectively, both written and verbally. •Performs documentation and calculations in accordance with SOPs and CGMP guidelines. •Operates manufacturing equipment and/or performs manual chemistry of moderate complexity for various phases of radiopharmaceuticals. •Works cross-functionally with other team members such as R&D, quality, and safety to develop and/or update SOPs for the manufacturing of radiopharmaceuticals. •Participates and performs effectively in a team environment. Proactively interacts with cross-functional departments such as quality and safety to ensure the operational success of the manufacturing areas. Qualifications: •Bachelor’s degree in a STEM field such as chemistry, engineering, or biology and/or an equivalent of relevant years of experience in the field required. •Manufacturing experience in radiopharmaceuticals, pharmaceuticals, biologics, or cell/gene therapy is required. •Strong mechanical aptitude and scientific background is required. •Must be capable of providing front line troubleshooting of manufacturing equipment and process issues and can properly elevate concerns and issues to appropriate personnel. •Demonstrated capacity to support 24-hour manufacturing and may require nights, weekends, and/or the ability to work overtime when necessary. •Superior teamwork, multi-tasking, and time management skills. •Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, internal and external. •Demonstrated capacity to work independently with minimal direction, and drive deliverables through to completion by deadlines provided. •Highly organized with strong attention to detail and commitment to high quality work. •Demonstrated capacity to work in a collaborative manner; identify challenges and barriers and recommend resolutions. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!