Manufacturing Technician

The Manufacturing Technician is responsible for the end-to-end preparation, formulation, aseptic filling, and packaging of radiopharmaceutical products in a highly regulated cGMP environment. Working within controlled cleanroom suites, this role supports daily production schedules, operates specialized equipment, and ensures all activities meet FDA regulations, ISO guidances, and other applicable regulatory requirements. The Manufacturing Technician maintains strict adherence to Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and radiation safety protocols. Serving as a key member of the production team, the Manufacturing Technician collaborates closely with Quality, Engineering, and Radiation Safety to achieve reliable, on-time supply of clinical and commercial doses while safeguarding product integrity and patient safety.

PRINCIPAL RESPONSIBILITIES:

Follow all quality, safety, radiation-protection, and regulatory requirements in accordance with written procedures and SOPs. Perform batch record calculations and maintain documentation that meets cGMP and Good Documentation Practice (GDP) standards. Clean and sanitize production equipment and facility areas—including hot cells, cleanrooms, and workstations as required per associated SOPs. Prepare cleaning solutions and perform routine sanitization in compliance with SOPs. Set up, operate, monitor, and clean production equipment and processes in accordance with cGMP and SOPs. Demonstrated ability to manufacture radiopharmaceutical drug products in strict accordance with Standard Operating Procedures (SOPs), including aseptic processing, aseptic filling techniques, and proper cleanroom behavior practices. Accurately complete documentation, follow detailed instructions, and communicate effectively both in writing and verbally. Work collaboratively in a team environment, interacting with multiple departments to ensure operational success. Meet or exceed internal and external customer expectations for quality and on-time delivery. Take initiative to achieve work goals, adapt to changing priorities, and address uncertainties in the workplace. Provide front-line troubleshooting of manufacturing equipment and process issues, escalating concerns appropriately. Demonstrate flexibility and a collaborative attitude to support departmental and organizational goals. Perform other job-related duties as assigned.

QUALIFICATIONS & REQUIREMENTS:

Associate or bachelor’s Degree in a life science. College level course work with scientific background is highly desired. Minimum of one-year relevant work experience, preferably in pharmaceutical, radiopharmaceutical, or cGMP manufacturing. Strong interpersonal skills with the ability to communicate clearly and promptly. Proven ability to take ownership of production processes, assigned areas, and associated documentation. Aseptic processing and technique experience preferred. Willingness to work in a facility handling radioactive materials and to follow all radiation-safety programs. Mechanical aptitude and manual dexterity for manipulating small items; ability to lift up to 50 lbs. and perform frequent crawling, stooping, crouching, and kneeling. Ability to wear a variety of personal protective equipment and maintain proper garbing and personal hygiene in cleanroom and compounding areas. Capacity to sit or stand for long periods and to work varying shifts, including overnight and weekends. Excellent communication, collaboration, and organizational skills, with the ability to work independently and meet deadlines. Commitment to strict health and hygiene standards to ensure product integrity and to report any health conditions that could pose contamination risks.

THE FINE PRINT:

The hourly range in Minnesota is $28.00 to $34.00 per hour. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location. #J-18808-Ljbffr Nucleus-Radiopharma