Manufacturing Specialist- Nights

Job Description

Job Description

POSITION SUMMARY :

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.

PRINCIPAL RESPONSIBILITIES :

• 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.

QUALIFICATIONS & REQUIREMENTS :

THE FINE PRINT :

The salary range in Minnesota is $75,000 to $90,000 per year. 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.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and / or other paid time off in compliance with applicable law. Relocation is available to qualified team members.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.