GMP Business Operations 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 Business Operations Manager

Duke Human Vaccine Institute

RESPONSIBILITIES :

• Develop and lead implementation of a long-term strategic plan and sustainable current Good Manufacturing Practices (cGMP) business model developed in partnership with DHVI leadership and the Sr. Director, GMP Program, that considers the unique academic environment where projects are funded through contract and grant mechanisms with differing milestones, timelines and budget requirements and reporting mechanisms. 
• The phases involved in the GMP process (cell line development, process development, manufacturing, stability, and fill-finish) require complex and logistical planning for timing of resources. Develop template budgets for mRNA or Protein platforms working with the Program Management and Finance teams.
• Work with the Sr. Director, GMP Program on the implementation of communication strategies to support DHVI GMP’s mission and activities with both internal and external constituents.
• Develop a process to ensure adequate effort management post award.
• Develop tools to monitor budget against original scope of work and establish a process for real-time adjustments to keep us within budget when there are changes to the scope of work or timeline.
• Become the point of contact for the DHVI scientific program team and finance teams for questions regarding GMP finances and projected costs.
• Assess the maintenance plan and coverage for all GMP and evaluate the strategic plan to allocate these costs.
• Work with central finance to manage the GMP annual operational budget, maintain expense control, and create secure short and long-term financial strategies to maximize funds.
• Maintain communication with DHVI, GMP, and Program Management leadership to report and address business and financial issues in a timely manner.
• Work with teams across the GMP program to accelerate the timelines for producing mRNA/LNP and protein vaccine candidates.
• Support GMP senior leadership business decision-making by managing, prioritizing, and synthesizing operational, space, and financial needs.
• Work with the Sr. Director, GMP Program to implement and maintain a positive work culture across GMP teams so that the units align priorities and goals.
• Perform other duties as assigned by GMP and DHVI leadership.

This position will report to DHVI’s Sr. Director of the GMP Program and be accountable to the Chief Administrative Officer and other DHVI executive leadership for reporting and deliverables. 

REQUIRED QUALIFICATIONS

Education/Training

Bachelor’s degree in a science, engineering, or related field. Advanced degree of MS/PhD is highly preferred, along with courses/degree work related to management and/or operations.

Experience

Requires eight years of experience in basic science research, with preferred experience in the biopharmaceutical or bioprocess industry. Previous direct or indirect supervisory experience is a plus.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.