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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 Scientist, 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 sponsor radiopharmaceutical products into and among our network of qualified manufacturing facilities. 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 and analytical equipment configuration, document creation, method validation, and process qualification, as well as occasional production and testing activities typical for a cGMP pharmaceutical manufacturing operation including 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.
Evaluate, create, adapt, and transfer manufacturing and testing procedures established by internal product development teams and external product sponsors for our network of cGMP manufacturing facilities
Generate all study protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products
Execute manufacturing and testing activities required for process qualification and method validation according to study protocols and standard operating procedures. Generate study reports where required
Complete equipment qualification, computer system validation, and cleaning verification protocols developed in partnership with validations personnel
Lead investigations and document deviations and exceptions occurring during technology transfer.
Train facility personnel on new manufacturing and testing procedures and provide routine production support following completion of technology transfer
Facilitate 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
Communicate all issues related to safety, quality, and compliance to leadership
Bachelor's degree in engineering or a physical science preferred
At least five years of experience working in a GMP environment in the pharmaceutical or biotechnology industry preferred
A background in product research and development preferred
Demonstrated experience in the operation, use, and maintenance of pharmaceutical production equipment and cleanroom facilities. 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
Ability to work in a controlled environment requiring special attention to environmental, health, and safety regulations. Position may require lifting or moving equipment weighing up to 40 lbs
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
Applicants with partial experience or qualifications exceeding those listed are encouraged to apply, as the organization may have additional openings which accommodate an alternate level of experience.
Anticipated Pay Range: $75,200.00-$107,400.00
Bonus Eligible: No
Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges – now, and in the future.As a global, growing company, we’re able to offer rewarding careers that let you make a positive impact on our customers and communities.