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Radiopharmacy Operations Supervisor

2 months ago

Piqua, Ohio, United States SOFIE Full time

Job Description | Pharmacy and Facility Manager

Title | Pharmacy and Facility Manager

Location | Miami, FL

Department | Operations

Reports To | Director, Operations

Overview

The primary responsibility of the Pharmacy and Facility Manager is to guarantee that all radiopharmacy functions within the designated site are executed according to the standards established by SOFIE. This role is pivotal in driving quality and safety across the site.



Essential Duties and Responsibilities
 Oversee the production of all radiopharmaceutical products at the facility; ensure timely doses are produced to fulfill daily requirements:
o Supervise all daily radiopharmacy activities.
o Maintain oversight of facility operations and personnel.
o Collaborate with the New Products Group to implement and sustain innovative radiopharmaceutical production for clinical trials.
 Lead multi-disciplinary teams (radiochemists, pharmacists, technicians, QA/QC, etc.) while upholding a high standard of performance and professionalism in alignment with SOFIE's corporate culture.
 Establish and uphold processes to ensure all facility operations meet scheduling (on-time delivery) and budgetary requirements to support the daily demand for all radiopharmaceuticals, including:

o Inventory Management:
 Timely and precise procurement of radiopharmaceuticals and other necessary supplies and materials.
 Responsible for initiating change controls and maintaining SOFIE network and site-specific procedures relevant to their job functions.
 Monitor inventory levels of traditional products (as applicable) and radiopharmaceuticals.
o Radiopharmaceutical Production (synthesis, QC/QA, dose preparation, etc.):

 Provide FDG, NaF, and New Products as requested by clients.
 Develop a fundamental understanding of all equipment functions (cyclotron, synthesis, QC, dispensing, etc.), system maintenance, and troubleshooting.
 Prepare reagents for synthesis utilizing standard laboratory equipment.
 Compound radiopharmaceuticals as necessary.
 Accurately dispense and distribute radiopharmaceuticals.

o Logistics Management:
 Adhere to DOT regulations and maintain delivery schedules.

o Facilities and Equipment Maintenance:
 Ensure that instruments, equipment, and other devices are kept in excellent working condition.
 Responsible for the health and safety of all employees, patients, and the public:
o Implement and enforce proper radiation safety protocols (handling spills, contamination, ALARA, etc.) to comply with state, federal, SOFIE, and customer standards.
 Collaborate with Regional Directors of Operations to establish and achieve targets for site revenue/profit, quality, safety, and production yields.
 Maintain accurate records to track radiopharmacy performance, yields, costs, etc., and organize and report quantitative results.
 Ensure compliance with SOFIE's quality assurance standards for all radiopharmaceuticals:
o Guarantee that all products meet regulatory standards.
o Conduct daily quality assurance of all radiopharmaceutical products manufactured at the facility (quality processes for production and optimization).
o Foster and uphold SOFIE's QA culture throughout the facility.
o Promote exceptional customer service.
o 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 high-pressure situations and emergencies in a composed, professional manner while adhering to SOFIE's Quality Assurance and Company Culture standards.
 Maintain open communication with all departments of the site team (cyclotron, production, QC, logistics, etc.) and across SOFIE.
 Create a working environment that balances employee morale and performance.

Qualifications
 Pharm.
D. from an accredited institution preferred.
o Authorized user status required.
o State license required in 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 strongly preferred (LIMS).
 Experience and understanding of Quality processes for manufacturing and production preferred (six-sigma, lean, critical parameters).
 Experience and understanding of Quality (QC/QA) concerning regulatory compliance strongly preferred.
 Ability to stand and/or remain seated for extended periods.
 Ability to lift 60 lbs., as needed.
 Ability to problem-solve, manage customer service issues, and exercise independent judgment and discretion.
 Strong interpersonal skills for engaging with Physicians, customers, vendors, and personnel required.
 Domestic travel for workshops and customer visits up to 10%.