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.

This role provides overall management and operational leadership to the PET Contract Manufacturing business by leading the implementation of technology transfer into our manufacturing network, leading the implementation team, allocating and prioritizing resources for implementation and ongoing manufacturing, overseeing ongoing relationships with the sponsor/innovator and ensuring the delivery of quality services and products in line with all quality and regulatory requirements. This role will have oversight of both commercial and pre-commercial PET Products manufactured within our PET Network on behalf of external sponsors or innovators.

Responsibilities:

• In partnership with the Tech Operations team, leads the implementation team in the technology transfer process of the contracted PET products. Responsible for interpreting scientific and technical requirements to ensure compliance with all regulatory & financial requirements.
• Accountable for defining and allocating needed resources for implementation and ongoing manufacturing in the network. Effectively partners with Zone Operations Directors to influence organizational changes needed, allocate local/regional resources to meet contract PET product demand. Provides overall guidance to these resources to ensure sponsor/innovator service and regulatory expectations are met.
• Responsible for managing relations with the sponsors/innovators. Serves as the key point of contact during and after implementation. Partners with Implementation Project Manager to establish key milestones and drive accountability with all key multi-functional partners.
• Oversees periodic operational and compliance reviews with sponsors/innovators to ensure established objectives, service levels and product demand are being met. Implements continuous improvements to drive efficiencies in these processes and other operational processes within scope of work.
• Accountable for administering all overhead costs of tech transfer implementation and ensuring operational plans are in line with business and strategic objectives.
• Deliver against key success metrics for the PET Contract Manufacturing business including compliance, financial and service metrics.
• Works cross functionally within Nuclear & Precision Health Solutions to deliver against the Contract Manufacturing strategic goals, leveraging resources beyond scope of direct responsibility.
• Complies with all training requirements to perform duties of the job.
• Leads and assists in continuous improvement projects, including participation on cross functional teams.
• Creates proposals and executes solutions based on approved recommendations.
• Researches, implements, and conducts ROI's on assigned budget projects.
• Performs other duties as assigned.

Qualifications:

• Bachelor's degree in a physical science, or a related degree preferred
• Nuclear experience and/or contract manufacturing experience required
• Project Management experience preferred
• FDA 21 CFR 212 PET CGMP nuclear manufacturing expertise required
• NRC PET nuclear manufacturing expertise required (i.e. NRC audits, RAM licenses, instrument calibration, Radiation Safety Officer duties)
• Awareness of radiopharmacy product dispensing modalities preferred
• Business acumen (drive for business results)
• Skill set must include, strong leadership and partnership skills, excellent communication skills
• Customer service mentality
• Demonstrated ability to work cross-functionally, collaboratively with internal and external partners
• Relationship builder, building bridges and alliances
• Willingness to roll up sleeves, work with any level in the organization if needed
• Ability to work in a highly regulated environment
• Build and develop short and midterm initiatives and long term strategies
• Willingness to travel up to 30 -40% of time

What is expected of you and others at this level:

• Utilizes broad and deep knowledge to develop innovative new business practices, policies and procedures
• Contributes to the development of department strategy
• Works on or may lead highly complex projects of large scope
• Projects are typically cross-functional and have significant and long-term impact
• Provides solutions which set precedent
• Negotiates complex or risky technical business issues on behalf of the company
• Independently defines project establishes budgets identifies participants and mitigates risk
• Consults with management to determine project objectives with long-term implications
• Acts as a mentor to less experienced colleagues

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.