Pharmacy Manager (Radiopharmaceuticals)
Company: SOFIE
Location: Gilroy
Posted on: August 2, 2022
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Job Description:
Title - Pharmacy Manager (Radiopharmaceutical)
Location - Gilroy, CA
Department - Operations
Reports To - Director, Operations
Overview
The Pharmacy Manager (Radiopharmaceutical)'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
D. from an accredited college is preferred.
Authorized user status 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%.
Keywords: SOFIE, Gilroy , Pharmacy Manager (Radiopharmaceuticals), Executive , Gilroy, California
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