GMP Project Manager

This Position is Grant Funded

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

GMP PROJECT MANAGER – SCIENTIFIC PROGRAM LEADER I

Duke Human Vaccine Institute

OCCUPATIONAL SUMMARY :

The Project Manager position will be responsible for the daily project management of assigned projects within the DHVI GMP Program (DGP) facility. This position’s responsibilities will include leading project-based teams within the DGP and providing organization and input for the GMP production of novel vaccine candidates. As the project manager, responsibilities will include managing and organizing kick-off meetings with project sponsors and internal stakeholders, developing and managing project timelines and project plans using traditional project management tools, providing input and updates in meeting with Program Management and Grant and Contract Managers. 

RESPONSIBILITIES:  

• Work with cross-functional project teams within the DGP (Process Development, Analytical Development, Operations, Quality and Program Management) to manage all aspects of project management from pre-kick-off project initiation/ planning to project closeout and CMC submission for the manufacturing of clinical trial material. Create and track project timelines, Gantt charts, and workflows. Understand the critical product development and GMP manufacturing milestones in the GMP process and collaborate with the area Subject Matter Experts (SMEs) to communicate progress and escalate issues as needed. Execute document development and GMP activities in compliance with regulatory requirements.
• Manage and coordinate the pre-award proposal process for GMP-specific activities, working with individuals at various levels in the organization to ensure successful integration of all parts and ensure full compliance with all funding solicitation and sponsor requirements. Ability to analyze and interpret data to drive team towards decisions.
• Provide routine project updates including project plan timelines, risks, action items, communication plans and escalations as required. Organize and facilitate internal and external stage gate reviews for assigned projects. Collaborate with other development teams to provide support for development activities and understand how key items impact the target product profile and product quality.  
• Conduct monthly project reviews including project plan updates, project financial status, maintain and update meeting minutes and collective team sites per sponsor requirements. Proactively measure and monitor project health according to established criteria. Communicate and author technical and routine program update reports per established frequencies.  
• Provide mentoring and coaching to junior staff. 
• Perform other duties as assigned by DHVI leadership. 

Required Qualifications at this Level :

• Education/Training: Completion of a Bachelor's degree in basic science, public health, clinical research or other related scientific field.
• Experience: Four years of program management and/or research experience. Experience in Biotech/Biopharma/Clinical Trials/GMP is strongly preferred. Additional training in project management or related training desired. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE 

Preferred Qualifications  

• Education: Graduate degree strongly preferred 
  • Completion of a Ph.D. or M.D. in basic science, public health, clinical research or other related scientific field with one additional years of program management and/or research experience required. OR 
  • Completion of a Master’s degree in basic science, public health, clinical research or other related scientific field with two additional years of program management and/or research experience required. OR 
  • Completion of a Bachelor’s degree in basic science, public health, clinical research or other related scientific field with four additional years of program management and/or research experience 
• Experience: Experience in Biotech/Biopharma/Clinical Trials is strongly preferred. Additional training in project management or related training desired.  

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