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Director of Operations - Biopharma

Employer
University of Rochester Center for Health & Technology (CHeT)
Location
14642, Rochester
Salary
Commensurate with experience
Start date
Jan 29, 2024

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better.  Our motto “Ever Better” means we improve the well-being of patients and communities by delivering innovative, compassionate, patient and family-centered care, enriched by education, science and technology. 

The Center for Health & Technology (CHeT) is in search of a Director of Operations to oversee the Clinical Material Services Unit (CMSU). Since its founding in 2008, the CMSU provides necessary supplies for clinical trials, managing the supply chain process and providing project management services. Our core services include secondary packaging, primary labeling, blinding, distribution, return services, regulatory support, and clinical label production.

Director of Operations - CMSU

As the Director of Operations, you will play a crucial role in overseeing all aspects of CMSU, ensuring compliance with cGMPs in the handling of investigational drug/device supplies. Collaboration with CMSU leadership and Finance is integral for business development, project management, and financial activities related to drug/device supplies.

Key Responsibilities:

Clinical Supplies Operations:

  • Manage the receipt, inventory, warehousing, packaging, labeling, distribution, accountability, and returns destruction of investigational drug/device supplies.
  • Collaborate with CMSU leadership and Finance on business development, project management, budgets, and financial activities.

Supply Chain Management:

  • Collaborate on study-specific Clinical Material Specification Sheets (CMSS) and process orders (PO).
  • Utilize GMP expertise to oversee secondary packaging, labeling, and distribution of drug/device products.

Personnel & Budget Management:

  • Provide direction for staff development, conduct performance evaluations, and make personnel recommendations.
  • Develop and manage the CMSU operational budget in collaboration with CHET Financial Leadership and CMSU Leadership.

Compliance and Facilities Management:

  • Ensure CMSU facilities and equipment comply with NYS, Federal, and ICH regulations.

The ideal candidate will bring:

  • Minimum 15 years relevant experience in clinical research, biopharma drug development, and/or healthcare industry experiences.
  • Minimum of 8 years’ proven leadership experience.
  • Strong working knowledge of investigational drug handling and distribution as well as the conducting and design of clinical trials.
  • Comprehensive understanding of regulatory standards pertaining to clinical trials.

 

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s Mission to Learn, Discover, Heal, create – and Make the World Ever Better.

In support of our values and those of our society, the University will select faculty and staff without regard to age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

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