WHAT NUCLEAR MANUFACTURING CONTRIBUTES TO CARDINAL HEALTH

Nuclear Manufacturing is responsible for the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e. FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring.
The Material Science and Technology Transfer Chemist, Nuclear Manufacturing position is part of a growing Technical Operations team within Cardinal Health’s Nuclear and Precision Health Solutions organization tasked with the development and technology transfer of radiopharmaceutical products into and among our network of qualified manufacturing facilities. This position will be responsible for the adaptation, setup, transfer, training, and maintenance of drug products with strict adherence to cGMP, GDP, environmental health and safety and related guidelines, and internal policies and procedures.

JOB SUMMARY

Specific duties will at a minimum comprise technical evaluation, process and analytical equipment configuration, document creation and technical review, executing method validation, and process qualification, as well as production and testing activities typical for a cGMP pharmaceutical manufacturing operation including but not limited to the preparation of chemicals and components, the operation of production and laboratory equipment, and the execution of standard operating procedures for routine manufacture and testing of radiopharmaceutical products. The preferred individual will possess sufficient technical, functional, and administrative competence to work largely independently, in a team environment, to meet program timelines and occasional production demands.
Schedule: 40 hours per week. Monday through Friday. 5:00 am - 1:00 pm

QUALIFICATIONS

• 2-4 years of experience, preferred
• Bachelor’s degree in related field, or equivalent work experience (analytical chemistry), preferred
• Demonstrated HPLC (High performance liquid chromatography) experience.
• Experience with Thermo fisher HPLC (High performance liquid chromatography) equipment strongly preferred
• Ability to manage up to 75 pounds
• Travel as necessary based on business needs (around 35% travel).
• Strong written and verbal communication.
• Demonstrated experience in the operation, use, and maintenance of pharmaceutical production equipment and cleanroom facilities preferred.
• Experience in the manufacture of radiopharmaceutical products preferred.
• Foundational expertise in the setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC/etc.) and modern chromatography data systems preferred.
• Ability to work in a controlled environment requiring special attention to environmental, health, and safety regulations.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements, including the ability to clearly document all work activities in a timely manner.
• Motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
• Desire to create, develop, and mature manufacturing and testing processes, and facility and systems infrastructure, to streamline operational efficiency across a broad range of products.
• Flexibility to work periodic off-shift hours to accommodate routine production schedules among qualified facilities.
• Prior Authorized User certification is preferred. Nuclear Pharmacy Training can be provided.

• Primary focus in this role delivers on all operational timelines as it relates to the technical transfer project.
• Secondary focus is day to day support for the manufacturing site or NPHS (Nuclear & Precision Health Solutions) projects.
• Executes of timelines, clear accurate communications, maintaining all required qualifications.
• Completes equipment qualification, computer system validation, and cleaning verification protocols developed in partnership with validations personnel.
• Leads investigations and document deviations and exceptions occurring during technology transfer.
• Trains facility personnel on new manufacturing and testing procedures and provide routine production support following completion of technology transfer.
• Facilitates day-to-day operation and maintenance of production equipment and testing instrumentation. Clean and maintain all production, testing, and related laboratory equipment during technology transfer.
• Collaborates and partners with cross functional teams.
• Communicates all issues related to safety, quality, and compliance to leadership.
• Travels as necessary based on business needs (around 35% travel).