Production Manager

3 days ago

Oakwood Village, United States SOFIE Full time

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.

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