Site Manager

4 weeks ago

Van Nuys, United States SOFIE Full time

Job Description | Site Manager
Title | Site Manager
Department | Operations
Reports To | Director, Operations

Overview


The Site Manager’s primary role is to ensure all facility operations within their site are performing to the standards set by
SOFIE. The Site 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 batches of product is
produced on- schedule to meet daily orders:
o Supervise all day-to-day facility operations.
o Maintain supervision for facility/operations and staff.
o Liaise with New Products Group to roll-out and sustain novel radiopharmaceutical production for clinical trials.
▪ Manage multi-disciplinary teams (radiochemists, QA/QC, etc.) and maintain a high standard of performance
and professionalism in line with SOFIE’s company culturestandards.
▪ Implement and maintain processes to ensure all facility operations meet requirements for schedule(on-time delivery)
and budget to support daily demand of all radiopharmaceuticals.
▪ Timely and accurate procurement and inventory of radiopharmaceuticals and other drugs, supplies, andmaterials.
▪ Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific
procedures relative to their job functions.
▪ Maintain DOT regulations and delivery schedules.
▪ Distribute radiopharmaceuticals properly and accurately.
▪ 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 facility performance, yields, costs, etc. and organize andreport
quantitative results.
▪ Ensure SOFIE’s quality assurance standards are met for allradiopharmaceuticals:
o Ensure all products comply with regulatory standards.
o Provide daily QA of all radiopharmaceutical products manufactured at the facility (quality processes for
production and optimization).
o Promote and uphold SOFIE’s QA culture throughout the facility.
o Promote quality customer service.
o Open, submit, and timely closure of quality documentation (e.g., CAPA, DEV, OOS, etc.).
▪ 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 across
SOFIE.
▪ Establish a working environment that is conscious of balancing employee morale and performance.

Normal Production/QC technologist duties, in addition to the following: (These skills are desired but may be learned on
the job.)


• Act as the facility liaison for the RCM group and contract partners.
• Complete required synthesis units’ operation training.
• Monitor routine synthesis unit parameters.
• Assist in routine, non-routine, and emergency maintenance on the synthesis unit.
• Have extensive knowledge of the operational principles of all synthesis units used at the respective site.
• Ensure completion of documentation related to synthesis unit operations for all production employees.
• Oversee and assist in the preparation and set-up of the synthesis unit as well as the safe delivery of the final product to
the pharmacy.
• Perform routine synthesis unit preventative maintenance.
• Provide information to the Regional Director of Operations regarding equipment operation and status.
• Perform basic operations of the particle accelerator.
• Assist the cyclotron engineer, as required, in the maintenance of the accelerator.
• Performs QC on manufactured batches and provide basic QC support.
• Perform radiation safety duties to assure compliance with all regulations as required.
• Assure compliance with all procedures, regulations, organizations, etc.
• Data gathering of manufacturing metrics.
• Provide cyclotron operation coverage when required by necessity.
• Assimilate the basics of cGMP.
• Ensures equipment is running optimally and that production employees are performing up to SOFIE standards.
• Responsible for seeing that Deviation Reports are properly investigated and documented.
• Responsible for ensuring the production and QC departments are clean and organized. This includes ensuring the
workspace is sanitized and floors are mopped by technicians.
• Responsible for ensuring all company procedures as well as Production and QC SOPs are implemented and followed.

Qualifications


▪ Bachelor’s degree from an accredited college preferred.
o Authorized user status or willingness to attain authorized user status in-house required.
• Strong management background managing diverse teams for a minimum of 5 years.
▪ Background in radiopharmaceuticals, Positron Emission Tomography, Radiation safety, and/or familiarity with
cyclotron processes desired.
▪ Certified cyclotron operator, or willingness to become certified in-house.
▪ 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 personnelrequired.
▪ Domestic travel for workshops and customer visits up to 10%.

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