Facility Manager

Sofie Sarl - Decatur, IL

Full-time - Mid Level

Decatur, IL

Chemical Manufacturing

About the position

The Facility Manager is responsible for overseeing all radiopharmacy operations at the facility, ensuring compliance with SOFIE's standards for quality and safety. This role involves managing production schedules, supervising staff, and maintaining high performance across multi-disciplinary teams. The Facility Manager also plays a key role in inventory management, logistics, and regulatory compliance, while promoting a culture of quality assurance and customer service.

Responsibilities

• Manage production of all radiopharmaceutical products at the facility, ensuring sufficient doses are produced on schedule to meet daily orders.
• Supervise all day-to-day radiopharmacy operations and maintain supervision for facility/operations and staff.
• Liaise with New Products Group to roll-out and sustain novel radiopharmaceutical production for clinical trials.
• Manage multi-disciplinary teams (radiochemists, pharmacists, technicians, QA/QC) and maintain high standards of performance and professionalism.
• Implement and maintain processes to ensure all facility operations meet requirements for schedule and budget.
• Timely and accurate procurement of radiopharmaceuticals and other drugs, supplies, and materials.
• Responsible for opening change controls and maintaining SOFIE network and site-specific procedures.
• Monitor inventory of traditional products and radiopharmaceuticals.
• Provide FDG, NaF, and New Products as required by customers.
• Establish a basic understanding of all equipment functions and system maintenance.
• Prepare reagents for synthesis using standard laboratory equipment.
• Compound radiopharmaceuticals as required and dispense them properly and accurately.
• Maintain DOT regulations and delivery schedules.
• Maintain instruments, equipment, and other devices in exemplary working order.
• Implement and enforce proper Radiation safety to meet state, federal, SOFIE, and customer standards.
• Work with Regional Directors of Operations to set and achieve targets for site revenue/profit, quality, safety, and production yields.
• Maintain accurate spreadsheets to track radiopharmacy performance, yields, costs, etc.
• Ensure all products comply with regulatory standards and provide daily QA of all radiopharmaceutical products manufactured at the facility.
• Promote and uphold SOFIE's QA culture throughout the facility and submit timely quality documentation.
• Directly responsible for interactions with and meeting the standards of the state Board of Pharmacy.
• Respond to stressful situations and emergencies in a calm, professional manner while maintaining SOFIE's Quality Assurance and Company Culture standards.
• Maintain open communication with all departments of the site team and establish a working environment that balances employee morale and performance.

Requirements

• Pharm.D. from an accredited college preferred.
• Authorized user status required.
• State license required in applicable state.
• Ground in Nuclear Pharmacy, Positron Emission Tomography, Radiation safety, and/or familiarity with cyclotron processes required.
• Proficient in MS Office required.
• Experience with Windows based pharmacy systems strongly preferred (LIMS).
• Experience with and understanding of Quality processes for manufacturing and production preferred (six-sigma, lean, critical parameters).
• Experience and understanding of Quality (QC/QA) with respect to regulatory compliance strongly preferred.
• Ability to stand and/or remain seated for extended periods of time.
• Ability to lift 60 lbs., as needed.
• Ability to problem-solve, handle customer service issues, and exercise independent judgment and discretion.
• Strong interpersonal skills for interacting with Physicians, customers, vendors, and personnel required.

Nice-to-haves

• Experience with Windows based pharmacy systems (LIMS) is strongly preferred.
• Experience and understanding of Quality processes for manufacturing and production (six-sigma, lean, critical parameters) is preferred.
• Experience and understanding of Quality (QC/QA) with respect to regulatory compliance is strongly preferred.