Cardinal Health PET Manufacturing Services is responsible for manufacturing PET isotopes to enhance patient treatment through improved disease diagnosis, staging, and monitoring.
Leveraging our fully integrated network of domestic nuclear pharmacies, Cardinal Health PET Manufacturing Services compounds, dispenses and distributes patient-specific, unit-dose PET products in pharmacy markets today.
What Chemical/ Pharmaceutical Ops contributes to Cardinal Health Operates automatic and manual manufacturing and chemical process equipment of varying complexity in various production processes in accordance with operating procedures. Performs a variety of tasks related to the processing of ingredients and/or radiopharmaceutical products. Handles raw materials and intermediate or finished products. Mixes compound ingredients for liquid products. May perform general maintenance as required on Gas Chromatographs, Ion Chromatographs, Multi Channel Analyzers, Dose Calibrators, analytical balance, etc. Performs standard operating procedures to meet current good manufacturing practices (cGMP). Maintains records as required. May monitor and verify quality in accordance with statistical process or other control procedures.
What is expected of you and others at this level in Manufacturing for functional success
- Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and
- Collaborates with others and builds strategic alliances globally; negotiates to build broad-based support and/or persuades others in order to
- Jointly develops practical implementation plans that consider cultural sensitivities with other accountable parties.
- Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity
- Identifies opportunities to improve efficiency while providing flawless transactions, services and products; manages monetary assets and other resources to optimize cost effectiveness.
Accountabilities in this role
- Utilize existing methodology to characterize materials, monitor chemical reactions and assure quality of final products as per SOP Strong record keeping, oral communication, and writing skills. Maintain all analytical instrumentation, supplies, reagents and necessary reference/standards
- Manufacture drug products (radio-pharmaceuticals)
- Monitor batch and continuous results in order to ensure quality production runs (I)
- Performs shipping and handling of radiopharmaceuticals as per SOP requirements, DOT, and IATA guidelines
- Prepares positron emission tomography (PET) isotopes, radiopharmaceuticals, including F-18 Fluorodeoxyglucose (FDG), by typing labels and entering information into a computer system.
- Performs quality assurance tests on instruments and pharmaceuticals in accordance with Federal, State, Company and manufacturer’s guidelines.
- Receives, documents, and stores incoming and outgoing pharmaceuticals according to the Department of Transportation and Company guidelines. Maintains raw-material records and internal inventory tracking including accepted, quarantined and rejected materials to ensure proper utilization and accounting of materials.
- Follow and adhere to all cgmps/compliance/regulatory mandates, SOP'S and quality requirements
- Identify and communicate processing related issues to production supervisor
- Work in collaboration with colleagues from the same and other departments such as quality, maintenance, and the laboratory
- Start and operate control tests on instruments and pharmaceuticals in accordance with Federal, State, company and manufacturer’s guidelines including K222, TLC, FDG TLS, pH test, half-life determination, LAL endotoxin test, sterility testing, purity (visual), radionuclide testing (MCA), filter integrity and solvency (GC).
- Start and operate the following equipment: gas chromatograph, dose calibrator, multi-channel analyzer, TLC plate scanner, high pressure liquid chromatograph, heating block, hot plate, pyrogen oven, incubator, analytical balance, desiccators, PTS, laminar flow hood and fume hood
- Monitor and interpret production methods during synthesis via computer and stack monitor.
- Perform radiation safety tasks including well checks and efficiencies, air monitoring, fume hood flow checks, room wipes and surveys, waste management and meter checks. Operate and record results from personal dosimetry devices, GM meters, stack monitor and neutron meter.
- Count, pour and draw in a syringe or vial according to state laws and company procedures.
- Perform clerical and administrative services including maintenance of daily delivery records, report preparation and maintenance records.
- Perform general laboratory and facility clean up.
- Initiate cyclotron software; perform visual operating inspections and cyclotron start-up. Operate cyclotron to produce isotopes, conditioning runs, target loading and emptying, target selection, drying of lines, etc. Under the supervision of an Authorized User.
- Compound chemicals used by the synthesis module and for solvents during QC procedures. Dispense and weigh chemicals and prepare the final product vials and Sep Paks used during the preparation/dispensing of radiopharmaceuticals
- Change O18 water and perform other assigned daily tasks for proper cyclotron operation.
- Survey and wipe the outgoing radiation products according to the Department of Transportation, State, Federal, and company guidelines
- Learn and practice FDA regulations as they pertain to the job function
- Must be able to work night shift and/or day shift. Facility operates at night and during the day.
- Location: Las Vegas, NV
- Bachelor of Science degree highly desired
- Manufacturing experience preferred 2 - 3 years
- Effective written and verbal English communication skills required
- Able to follow detailed processing instructions
- Lifting: Frequent lifting between 50-75 lbs
- Ability to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions ; Ability to exercise sound judgment Personal Protective Equipment
- Ability to see fine particulate and differentiate colors.
- Ability to hear, write, and speak clearly in order to communicate in manufacturing setting.
- Manual dexterity required for occasional reach and lifting of small objects.
- Demonstrated manual dexterity in order to draw doses and manipulate remote arms and Quality Control equipment.
- Ability to be an effective team member.
- Must be able to work nights and rotate as needed-- 8 hour shift during the hours of 930pm through 7am
The primary work environment consists of a cyclotron and associated cGMP manufacturing facility for the production of PET radiopharmaceuticals; which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Drug products are manufactured using aseptic techniques. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.