Manager, Nuclear Manufacturing

Anticipated pay range: $103,500 - $155,295

Bonus eligible: Yes

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 01/05/2024 *if interested in opportunity, please submit application as soon as possible.

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.

Job Description Summary

• The Manager, Quality Control, Nuclear Manufacturing, is a key member of Cardinal Health's growing Technical Operations team within the Nuclear and Precision Health Solutions (NPHS) organization.
• Responsible for routine quality control chemistry testing of theranostic radiopharmaceutical drug products under strict adherence to GMP, GDP, and Radiation Safety requirements
• The Quality Control Manager will oversee a team of quality control chemistry personnel toward efficient test planning and execution, effective change management for existing products, and implementation of new analytical methods and processes supporting new products.
• The ideal candidate will possess extensive experience in GMP quality control testing, strong proficiency in analytical techniques, and have a proven track record of leading laboratory investigations and improvements.
• Experience with regulatory guidelines, troubleshooting and maintaining analytical instrumentation, and strong communication and leadership skills are essential.

Responsibilities

• Planning and performing routine quality control testing: Conducting chemical analysis of radiopharmaceutical products and incoming materials while adhering to GMP, GDP, and radiation safety requirements.
• Supervising a team of quality control chemists: Providing technical expertise and leadership to a team, ensuring they effectively perform routine testing and equipment upkeep, and support the analytical aspects of technology transfer programs.
• Implementing new analytical methods: Developing, transferring, and validating new analytical methods to support the testing of radiopharmaceutical drug products.
• Maintaining compliance: Ensuring all activities are documented accurately and comply with relevant regulatory guidelines (USP/EP/ISO/ICH/CFR) and Cardinal Health standard operating procedures (SOPs). Provide technical expertise during change controls, deviations, and investigations as necessary.
• Collaborating with stakeholders: Working with internal and external partners to understand scientific, quality, and business needs related to radiopharmaceutical products.

Qualifications

• Education and Experience: Bachelor's degree (or higher) in a physical science with at least 5 years of progressively increasing experience in a GMP environment (pharmaceutical, biotechnology, and/or radiopharmaceutical industries). Previous supervisory experience is strongly preferred.
• Technical Expertise: Demonstrated advanced knowledge and experience in radiopharmaceutical techniques as well as operating, maintaining, and troubleshooting analytical instrumentation common in radiopharmaceutical production (e.g., HPLC, TLC, GC, ICP-MS, HPGe, gamma and LSC counters,  dose calibrators).
• Compliance and Documentation: Strong commitment to data integrity through strict adherence to standardized procedures and regulatory requirements. Ability to effectively document and maintain records related to changes, maintenance, repair, and historical data trends for analytical instrumentation.
• Teamwork and Communication: Excellent interpersonal skills, including the ability to influence others, resolve challenges diplomatically, and build strong working relationships across departments. Exceptional oral and written communication skills for effective interaction with all levels of employees, senior leadership, and external partners.
• Leadership: Proven leadership skills, including the ability to set direction, inspire, motivate, and mentor a quality control chemistry team.
• Flexibility: Willingness to work periodic off-shift hours, including occasional weekends, to support routine testing or project needs.