Associate Director, GMP Manufacturing & Operations

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Associate Director, GMP Manufacturing & Operations

Duke Human Vaccine Institute

 

Occupational Summary: 

 

As a member of the GMP leadership team, the Associate Director of GMP Manufacturing and Operations will report to the Sr. Director of Product Development and will directly manage the members of the DHVI GMP Operations Team in all activities, including preparation for manufacturing of products, working with Product Development and DHVI leadership for scheduling, preparing manufacturing suite facilities, and working with the DHVI Product Development leadership and staff in ordering, maintaining an inventory of supplies for product manufacture, and facility cleaning. The Associate Director will ensure compliance in all aspects of GMP Operations manufacturing activities.   

 

The Associate Director will work with the financial staff of the DHVI Product Development Unit and DHVI financial and program teams to ensure adherence to budgets and to directly discuss with Product Development and DHVI leadership all issues related to product development and manufacturing. In addition, the Associate Director will perform other duties as determined by the Sr. Director of Product Development and DHVI leadership. 

 

The Associate Director is expected to serve as a leading operation expert, providing guidance, recommendations, and judgment for strategic technical issues and decisions. The Associate Director, as an employee of Duke University, will provide senior level oversight, management, and coordination of GMP manufacturing operations and activities. The Associate Director will also assist the DHVI Leadership Team and the Sr. Director of Product Development in developing and refining strategies to accomplish DHVI's mission and will identify and implement the infrastructure necessary to support the successful execution of these strategies. The Associate Director will orchestrate efforts to effectively leverage the participation of a variety of external stakeholders, foster collaborations, and promote the reach and awareness of DHVI. The Associate Director will lead internal Duke staff working for DHVI GMP Manufacturing and oversee technical manufacturing functions to expedite the conduct and completion of GMP projects. The Associate Director will directly report to the Sr. Director of Product Development and indirectly to the DHVI Chief Operating Officer and DHVI Director.  

 

Work Performed: 

• Directly accountable for GMP manufacturing operations. The role will actively collaborate with Analytical Development, Facilities Manager, GMP Quality Control, GMP Program Management, Regulatory Affairs, and Business Development.  
• Maintains compliance with all federal regulations and safety procedures. This position will also ensure and quantify robust metrics of all existing and new manufacturing campaigns leading to the highest batch success rate possible.  
• Collaborates with process development, Research, sponsors and internal/external manufacturing teams to support New Product Introductions, enabling on-time, right-first-time vaccine technology transfers. 
• Builds and maintains strong and trusting relationships with R&D Leaders, SOM leaders, GMP team leaders, functional management, and other stakeholders to ensure effective communication of plans and issues.
• Stays abreast of scientific developments and trends in manufacturing technologies and participates in external industry/regulatory forums in order to maintain an industry-leading level of subject proficiency.  
• Provides technical/scientific guidance and oversight to project teams facilitating process transfer to GMP operations, work with process development teams to implement improvements in manufacturing. 
• Provides technical/scientific guidance to support investigations, deviations,