Cardinal Health is looking to solve the problem of manufacturing time-sensitive radiopharmaceuticals in a highly regulated environment to support patient treatment through disease diagnosis, staging, and monitoring.
Requirements
- Foundational expertise in the setup, operation, and maintenance of conventional process instrumentation and modern automated synthesis systems.
- Experience working in a GMP environment in the pharmaceutical or biotechnology industry preferred.
- A background in product research and development preferred.
- Ability to work in a controlled environment requires 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.
- Desire to create, develop, and mature 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.
Responsibilities
- This position will be responsible for the adaptation, setup, transfer, and maintenance of sponsor drug products with strict adherence to cGMP, GDP, environmental health and safety and related guidelines, and internal policies and procedures.
- Specific duties will at a minimum comprise technical evaluation, material selection, process equipment configuration, document creation, and process validation, as well as occasional testing activities typical for a cGMP pharmaceutical manufacturing operation, including the preparation of chemicals and components, the operation/maintenance/repair of laboratory equipment, and the execution of standard operating procedures for routine testing of radiopharmaceutical products.
- Evaluate, create, adapt, and transfer testing procedures established by internal product development teams and external product sponsors for our Indianapolis Theranostics cGMP radiopharmaceutical manufacturing facilities.
- Generate study protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products.
- Execute activities required for process validation according to study protocols and standard operating procedures. Generate study reports where required.
- Complete equipment qualification and computer system validation protocols developed in partnership with Validations personnel.
- Lead investigations and document deviations and exceptions occurring during technology transfer.
Other
- 4-8 years of experience, preferred
- Bachelor's degree in related field, or equivalent work experience, preferred
- Position may require lifting or moving equipment weighing up to 40 lbs.
- Motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
- May act as a mentor to less experienced colleagues
