Director of Operations, Nuclear Manufacturing

Cardinal Health•Colton, CA

4d•Remote

About The Position

The Director of Operations, PET Nuclear Manufacturing will provide overall management and operational leadership to the PET Manufacturing business by way of collaborative relationships with all cross functional leaders and teams. This leader will oversee the PET manufacturing sites within their region ensuring the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e., FDA, NRC, DOT, etc.) to support patient treatment through disease diagnosis, staging, and monitoring. This is a remote, work from home position that will require ~60% travel. The candidate must live in the West Region, ideally within Texas or the Phoenix area.

Requirements

Bachelor's degree in a physical science, or a related field or equivalent experience preferred
12+ years of experience in related field is preferred.
Strong leadership skills, including proven success in managing teams and ideally with other people leaders.
Proficient in FDA 21 CFR 212 PET cGMP and NRC/State nuclear manufacturing regulations (e.g., NRC/FDA audits, RAM licenses, instrument calibration, Radiation Safety Officer duties), with the ability to thrive in a highly regulated fast paced environment.
Must be or become a Radioactive Material Authorized User.
Strong business acumen, including strategic planning (short, mid, and long-term initiatives) and budget management, with a drive for results.
Exceptional collaboration, partnership, and relationship-building skills, with a customer-centric approach and the ability to work effectively across all organizational levels and with external partners.
Excellent communication skills.
May be required to be trained and qualified to manufacture all drugs within the region.
Customer service mentality.
Candidate must live in West Region, ideally within Texas or the Phoenix area.
Willingness to travel up to 60% or as needed.

Responsibilities

Fosters strong cross functional relationships, provides leadership, and drives positive team dynamics and organization change.
Plays integral role in development of PET Operations strategy, priority alignment, and development/implementation policies and programs for execution.
Leads and manages managers, experienced staff, and when applicable, front-line supervisors.
Manages employee development, engagement, succession planning, and retention.
Leads and supports PET continuous improvement and enterprise initiatives. (Product Development, network expansions/remodels, etc.).
Is a resource as needed for review, approval, and ownership of all-encompassing document management program (document owner, DCR/ECR owner, approver, etc.).
Partners with Contract Manufacturing Organization (CMO) Director to ensure contract compliance during technology transfer, clinical trials, and commercial manufacturing.
Collaborates with Quality Assurance, Microbiology Department, and Quality and Regulatory to establish and maintain robust programs, maintaining compliance, and partnering when responding to auditors on site and audit citations.
Partners with project managers/teams to establish key milestones and drive accountability and completion.
Oversees periodic operational, business and compliance reviews with area operational and quality managers to ensure PET sites are delivering against key success metric objectives, service levels and product demand.
Partners with pharmacy teams through cadence meetings (etc.) to foster and drive “One Team” culture.
Manages business resources, including managing SG&A, travel, labor, and operational efficiencies.
Identifies and implements efficiency improvements and contributes to functional strategies.
Conducts periodic onsite visits to PET sites.
Participate in and leads selected network-wide initiatives (e.g., material management task force, equipment manager, MBOs/metric content, industry meeting, National Field Meeting, I.T.).