Production Specialist, Nuclear Manufacturing

Cardinal Health

About The Position

What Nuclear Manufacturing contributes to Cardinal Health Manufacturing is responsible for cost of production and maintenance activities including process improvement, supply chain management, quality assurance, employee safety and engagement, and environmental commitment. 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. Responsibilities Support the manufacturing activities from internal product development and external sponsors. Receive, sample, store and/or distribute all materials required for production. Safely receive, handle, and transfer radioactive isotopes and final products to end users. Facilitate day-to-day operation and maintenance of the facility, production equipment, radiation monitoring equipment, and testing instrumentation. Perform hands-on execution of manufacturing procedures, following standard operating procedures (SOPs), master batch records (MBRs), and protocols. Lead and/or support investigations and documentation of deviations and non-conformances. Clean and maintain all production equipment, including clean rooms and isolators. Record and maintain systems regarding cGMP compliance such as consumable inventory levels, area classification requirements, or site environmental monitoring. Communicate all issues related to safety, quality, and compliance to site leadership. Perform relevant documentation for maintenance activities, as well as modify and/or create SOPs. Provide input to the Product Development team regarding client drug manufacturing.

Requirements

Bachelor’s degree in life sciences or engineering preferred.
At least 2 years of experience working in a GMP manufacturing environment in the pharmaceutical or biotechnology industry preferred.
Demonstrated familiarity with the operation, use, and cleaning of laboratory scale production equipment.
Ability to work in a controlled environment requiring special attention to environmental, health, and safety regulation.
Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements; 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.
Flexibility to work periodic off-shift hours in support of routine production.
Must be able to lift up to fifty (50) pounds

Nice To Haves

Experience working in clean rooms/ISO5-8 environments/isolators not required, but is a plus.
Experience working with radioactive isotopes not required, but is a plus.

Responsibilities

Support the manufacturing activities from internal product development and external sponsors.
Receive, sample, store and/or distribute all materials required for production.
Safely receive, handle, and transfer radioactive isotopes and final products to end users.
Facilitate day-to-day operation and maintenance of the facility, production equipment, radiation monitoring equipment, and testing instrumentation.
Perform hands-on execution of manufacturing procedures, following standard operating procedures (SOPs), master batch records (MBRs), and protocols.
Lead and/or support investigations and documentation of deviations and non-conformances.
Clean and maintain all production equipment, including clean rooms and isolators.
Record and maintain systems regarding cGMP compliance such as consumable inventory levels, area classification requirements, or site environmental monitoring.
Communicate all issues related to safety, quality, and compliance to site leadership.
Perform relevant documentation for maintenance activities, as well as modify and/or create SOPs.
Provide input to the Product Development team regarding client drug manufacturing.