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.