Production Manager at SOFIE

Production Manager

The Production Manager will supervise and coordinate all production-related activities at a site level.

Essential Duties and Responsibilities

Normal Production/QC technologist duties, in addition to the following:

• Act as the facility liaison for the RCM group and contract par
• 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 the FDG and other drug products 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.
• Oversee inventory of supplies used in FDG, and all other products manufacturing.
• Provide information to Facility Manager 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.
• Demonstrates a commitment to quality.
• Ensures equipment is running optimally and that production employees are performing up to SOFIE standards.
• Responsible for accurately managing inventory (spare parts and consumable materials as required by TSG).
• Responsible for accurately managing Physical Inventory.
• Responsible for completing a weekly “Critical Inventory” spreadsheet.
• Responsible for ensuring the “Daily Summary” in the Production Database (which reports to the Operation’s database) is filled out by production employees at the end of each day.
• Responsible for attending a weekly Production Manager conference call during work hours and outside of work hours..
• Responsible for seeing that a Deviation Report is properly investigated and documented.
• Responsible for production employees’ scheduling as well as approving PTO’s and tracking vacations.
• 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 tracking radiation exposure of production personnel and seeing that principles of ALARA are maintained.
• Responsible for ensuring all company procedures as well as Production and QC SOPs are implemented and followed.
• As a Production Manager, you will be issued a company cell phone and must be available 24/7 for technical or administrative support.
• Responsible for training new personnel.
• Responsible for annual performance review of all production personnel .
• Responsible for finding ways to reduce production costs and responsible for working with the pharmacy manager to stay within budget.
• Responsible for keeping the synthesis units maintained. Sunday is normally preventative maintenance day.
• Responsible for monitoring your site’s production performance. May be asked to collect data, prepare spreadsheets, or prepare graphs for analysis.
• Responsible for communicating with other department managers to discuss operations, issues/concerns, new ideas, and continuous quality improvement.
• Responsible for logging all incoming inventory and making sure they pass Acceptance criteria per SOPs as required per site.
• Responsible for communicating with the pharmacist on duty to inform him/her of late productions, problems with the cyclotron, issues with chemistry, or any problem that could cause doses to be late to our customers.
• On weekly calls.
• Clear and concise communication within department.
• All other duties as assigned.

Education and/or Experience

• Certified Cyclotron engineer or operator. 
• SOFIE Production tech training.
• SOFIE QC training.
• SOFIE Radiation safety training. 
• Hands on knowledge in production and QC. 
• High School Diploma or GED.
• Must be able to read, write, and speak English.
• Associates Degree or equivalent in a Technical Discipline; either electronics or mechanical competencies (Preferred).
• Ability to perform diagnosis and repair on common electronic equipment (Preferred).
• Working knowledge of electronic test equipment (Preferred).
• Mechanical tools used in chemical processor maintenance.
•          Ability to read and comprehend simple instructions, short correspondence and memos.
•          Ability to write simple correspondence.
•         Ability to effectively present information in one-on-one and small group situations to customers, clients and other employees of the Company.
•           Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. 
•          Ability to compute rate, ratio and percent and to draw and interpret bar graphs.
•          Ability to define problems, collect data, establish facts and draw valid conclusions.
•          Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
•          Working knowledge of MS Office applications.
•          In depth knowledge of production logging software, Millennium, and other applications.
•          Basic understanding of DOS commands is preferred.
•          Individual must be detailed oriented, accountable, patient, and must be able to work in a team environment with minimum supervision.
•          Climb ladder and stairs.
•          Operate in confined spaces i.e. inside or underneath the cyclotron.
•          Able to lift a minimum of 50 pounds.
•          Perform tasks requiring fine motor skills i.e. work repeatedly with small parts.
•         Occupational exposure to ionizing radiation.
•          Shift work including but not limited to weekend call shifts.
•          General chemistry lab work i.e. handling of acids and bases including but not limited to sulphuric acid and sodium hydroxide
•          Clean driving record
•          Ability to travel to accounts and trade shows as necessary.
•          Strong interpersonal skills for interacting with all levels of the company.
•          Experience in problem solving. 
•          Strong management skills necessary.