Key Responsibilities: Ensure all production activities follow FDA, cGMP, radiation safety, and other regulatory standards.Plan and manage production schedules to meet customer needs.Hire, train, and manage production staff, including setting goals and handling performance reviews.Support inventory, facility upkeep, and equipment maintenance and calibration.Operate moderately complex equipment to produce radiopharmaceuticals.Help investigate and resolve production or quality issues.Collaborate with researchers to develop new radiopharmaceuticals at the Rochester, MN site.Work closely with quality, procurement, radiation safety, and other teams to ensure products are shipped correctly the first time.Help design and source equipment and materials for current and future production needs.Create and maintain SOPs, training materials, and validation documents for production processes.  Qualifications & Requirements: Bachelor’s degree in a STEM field or equivalent experience/training.Experience working in GMP manufacturing and knowledge of FDA cGMP regulations.3–5 years of hands-on experience in radiopharmaceutical production.Skilled in aseptic techniques and sterile processing.Proven ability to lead teams in a cross-functional environment.Strong organizational, multitasking, and time management skills.Able to prioritize tasks and make decisions under pressure.Comfortable evaluating and sourcing technical equipment.Excellent communication, problem-solving, and computer skills (Microsoft Office and related tools).Willing to work flexible hours, including nights and weekends.Physically capable of handling small parts, lifting up to 50 lbs., and performing tasks that require bending or kneeling.Open to occasional travel (up to 10%).Must follow strict hygiene and safety protocols in cleanroom environments.Required to report any health conditions that could affect product safety.Chronic health issues impacting job performance may require review.Must maintain proper cleanroom attire and hygiene at all times.

SciPro have exclusively partnered with an innovative pharmaceutical company who are driven by their purpose to reimagine how drugs can improve the quality of life of patients with rare disease. They are a fast growing, agile organization transforming the lives of patients and care givers through the use of cutting-edge pharmaceutical technologies to translate pioneering science to medicine products. We are supporting them on their search for a Senior Regulatory Affairs Associate to lead compliant product labelling and artwork of their product portfolio. You will join the Regulatory Affairs team in the UK and have the chance to make a real impact on multiple projects to support the company growth and ultimately, make a difference to the patients the company support. Key Responsibilities: Lead U.S. labelling and artwork activities Lead the preparation of ANDA/NDA submissions Lead promotional material submissions to the FDA Key Requirements: 4+ years of regulatory affairs experience Experience with Adobe Illustrator or Adobe InDesign Prior experience with US FDA regulations