Director of Operations

About CMSU

Founded in 2008, the Clinical Materials Services Unit (CMSU) at the University of Rochester exists to support the full lifecycle of clinical trials — from first shipment to final accountability. Born from a recognized need among the University's clinical investigators, CMSU provides an on-site, dedicated facility managing end-to-end supply chains for NIH and industry-sponsored research conducted globally through the University.

Core capabilities include secondary packaging, primary labeling, blinding, distribution and return services, regulatory support, and clinical label production.

The Opportunity: Director of Operations

CMSU is seeking a dynamic and experienced Director of Operations to lead all aspects of clinical supply operations and clinical pharmacy information services. This is a high-impact leadership role for someone who thrives at the intersection of science, operations, and compliance.

What You'll Own

You'll provide strategic leadership and oversight across CMSU's operations — including serving as the central pharmacy for NIH, industry, and research networks — while ensuring full regulatory compliance with:

• Current Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs), and Good Laboratory Practices (GLPs)
• FDA and ICH regulations governing the receipt, storage, inventory control, quality assurance, distribution, accountability, and destruction of investigational drugs and devices
• 21 CFR Part 11 technologies (e.g. ClinPro LBL, temperature monitoring), maintained in close collaboration with the Sr. Director and Director of Quality Assurance

Beyond compliance, you'll develop and implement training programs for FDA-regulated research activities, serve as a clinical pharmacy information resource throughout the planning and implementation stages of studies, and liaise directly with both internal and external sponsors.

Who We're Looking For

The ideal candidate brings a background in science or healthcare manufacturing, with direct experience in clinical trials and deep expertise in supply chain management. You're a systems thinker who can lead teams, navigate complex regulatory environments, and drive operational excellence in a mission-driven research setting.

Interested? Read the full job description here: Director of Operations, CMSU

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