Director, Operations CMSU Job at University of Rochester (Rochester)

Job Description

To direct, oversee and coordinate all aspects of the Clinical Material Services Unit (CMSU) related to clinical supply operations and clinical pharmacy information services. Ensure compliance with Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs) standards meeting the requirements of FDA and ICH regulations and applicable professional standards pertaining to receipt, storage, inventory control, quality assurance, distribution, accountability and destruction of investigational drugs/devices.

Job Responsibility

Direct the Clinical Supplies Operations Group
Responsible for all aspects of drug/device supply operations
Management of CMSU Operations Personnel
Oversee team and ensures that the CMSU facilities and equipment remain in full compliance with all NYS, Federal, and ICH regulations
Work in collaboration with CMSU Leadership and Project Manager to provide input and oversight in creation of study specific Clinical Material Specification Sheets (CMSS) and process orders (PO)
In conjunction with the CHET Financial Leadership and CMSU Leadership, develop the CMSU operational budget and assist and managing to it
Responsible to ensure that the CMSU’s time and effort is accurately reported by project to the CHET finance team for billing to each project
Work in close collaboration with the Quality Assurance Group
Responsible for ensuring regulatory compliance with investigational drug/device regulations and actively supporting IND submission for internal/external clients with focus on the Chemistry, Manufacturing and Control (CMC) section of the IND

Requirements

BS degree required
Doctorate degree in pharmacy and Business administration background, preferably with an MBA preferred
3 years of relevant experience required
15 + years’ experience in the pharmaceutical industry with strong working knowledge of FDA compliance, including cGMP and clinical supplies preferred
Minimum of 8 years proven leadership, supervisory and people management experience preferred
Strong working relationships with executives in the clinical trial supply and pharmaceutical industries required
Experience contracting with and managing contract vendors
Strong working knowledge of investigational drug handling and distribution as well as the conducting and design of clinical trials
Strong organizational and communication skills required
Strong computer skills required
Ability to work in a fast paced, ever changing work environment
Licensed, or eligible for licensure, as a pharmacist in New York State preferred

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Director, Operations CMSU

Job Description

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