Manufacturing Specialist- Nights

Overview

4 days ago Be among the first 25 applicants

This range is provided by Nucleus Radio Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$75,000.00/yr - $90,000.00/yr

The Manufacturing Specialist-Night Shift will play an essential role in the overnight manufacturing and production operations of theragnostic radiopharmaceuticals. This individual will perform all manufacturing-related tasks and support functions during the night shift, including but not limited to routine cleaning of rooms and equipment, reagent preparation, component assembly, formulation, dispensing, and packaging of radiopharmaceuticals. Work will be completed in accordance with current good manufacturing practices (CGMP), established standard operating procedures (SOPs), safety requirements, and quality processes to meet sponsor requirements.

The Manufacturing Specialist-Night Shift will operate as an independent contributor with strong decision-making abilities, discretion, and judgment while maintaining advanced knowledge of equipment and manufacturing processes. This role requires a high level of autonomy and the ability to effectively communicate and coordinate with day-shift counterparts to ensure seamless 24/7 operations.

• Perform all core manufacturing functions during the night shift, ensuring uninterrupted operations and product availability.
• Lead and support other team members working nights, reinforcing manufacturing goals, standards, and behaviors on and off the manufacturing floor.
• Ensure strict adherence to quality, safety, and regulatory requirements (CFR, FDA, OSHA, MN DHS) during night operations.
• Complete routine cleaning, equipment setup, daily checks, and operation of manufacturing equipment following CGMP, SOPs, and aseptic techniques.
• Perform accurate documentation and calculations per SOPs and CGMP guidelines.
• Operate manufacturing equipment and/or conduct manual chemistry processes of moderate complexity for radiopharmaceutical production.
• Work cross-functionally with R&D, quality, and safety teams through documented communication and scheduled handoffs to ensure alignment between shifts.
• Write documentation and contribute to training programs to ensure ongoing success of night shift operations.
• Assist in scheduling and staffing coverage for the night shift to support 24/7 manufacturing needs.
• Monitor night shift inventory of materials and consumables and prepare shift handoff reports for continuity of supply chain and equipment status.
• Support investigations, deviations, root cause analyses, and non-compliance events as they arise during the shift.
• Demonstrate flexibility and adaptability in responding to urgent needs or changes in production priorities overnight.
• Perform other job-related duties as assigned.

• 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.
• Minimum 2 years of relevant experience working in an FDA CGMP regulated environment with 21 CFR Parts 210 and 211 required. Experience in Part 212 is also acceptable.
• Experience in aseptic processing and techniques required.
• Manufacturing experience in radiopharmaceuticals, pharmaceuticals, biologics, or cell/gene therapy is required.
• Experience working with hot cells and automated processing equipment strongly preferred.
• 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.
• Ability to work overnight schedules consistently, including weekends and extended hours as needed, to support 24/7 manufacturing needs.
• 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.
• Ability to work independently with minimal direction, and drive deliverables through to…