Facility Manager (Radiopharmaceuticals) at SOFIE

Overview
The Facility Manager’s primary role is to ensure all radiopharmacy operations within their site are performing to the standards set by SOFIE. The Facility Manager should be the key driver of quality and safety for the site.

Essential Duties and Responsibilities

·       Manage production of all radiopharmaceutical products at the facility; ensure sufficient doses are produced on- schedule to meet daily orders:

·       Supervise all day-to-day radiopharmacy operations.

·       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, etc.) and maintain a high standard of performance and professionalism in line with SOFIE’s company culture standards.

·       Implement and maintain processes to ensure all facility operations meet requirements for schedule (on-time delivery) and budget to support the daily demand of all radiopharmaceuticals, including:

Inventory management:

·       Timely and accurate procurement of radiopharmaceuticals and other drugs, supplies, and materials.

·       Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.

·       Monitor inventory of traditional products (as applicable) and radiopharmaceuticals.

·       Radiopharmaceutical production (synthesis, QC/QA, dose drawing, etc.):

·       Provide FDG, NaF, and New Products as required by customers.

·       Establish a basic understanding of all equipment functions (cyclotron, synthesis, QC, dispensing, etc.), system maintenance, and troubleshooting.

·       Prepare reagents for synthesis using standard laboratory equipment.

·       Compound radiopharmaceuticals as required.

·       Dispense and distribute radiopharmaceuticals properly and accurately.

Logistics management:

·       Maintain DOT regulations and delivery schedules.

·       Facilities and equipment upkeep:

·       Maintain instruments, equipment, and other devices in exemplary working order.

·       Responsible for the health and safety of all employees, patients, and the public:

·       Implement and enforce proper Radiation safety (handling spills, contamination, ALARA, etc.) 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., and organize and report quantitative results.

·       Ensure SOFIE’s quality assurance standards are met for all radiopharmaceuticals:

·       Ensure all products comply with regulatory standards

·       Provide daily QA of all radiopharmaceutical products manufactured at the facility (quality processes for production and optimization).

·       Promote and uphold SOFIE’s QA culture throughout the facility.

·       Promote quality customer service.

·       Submit timely quality documentation (e.g., CAPA, DEV, OOS, etc.).

·       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 (cyclotron, production, QC, logistics, etc.) and

·       Establish a working environment that is conscious of balancing employee morale and performance.

Qualifications

·       Pharm.D. from an accredited college is preferred.

·       Authorized user status is required.

·       State license required in the applicable state.

·       Background 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 is 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 are 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.

·       Domestic travel for workshops and customer visits up to 10%.