Duke University, Duke Human Vaccine Institute
Position ID:
Duke-Duke Human Vaccine Institute-DIR [#32280]
Position Title:
Director, Cellular Therapies and Tissue Products (GMP)
Position Type:
Other
Position Location:
Durham, North Carolina 27710, United States of America
Subject Area:
Appl Deadline:
2026/08/07 23:59:59 (posted 2026/07/06, listed until 2026/08/07)
Position Description:
Position Description
Recruitment for Director, Cellular Therapies and Tissue Products (GMP) July 6, 2026 The Duke University School of Medicine seeks a Director of Cellular Therapies and Tissue Product GMP. This important position encompasses a broad range of responsibilities including overseeing management of the GMP manufacturing units supporting process development and manufacturing under IND or GMP of cellular therapies and tissue-based products for adult and pediatric populations. The Director will provide leadership for GMP operations, which includes two GMP facilities and the process development teams. Depending on the background and experience of the candidate, the position may also serve as Medical Director, supervising clinical trials in cell therapy and regenerative medicine in adults. The position reports to the Associate Dean for Duke RTP Administration and GMP and provides vision and leadership for Cellular Therapies and Tissue Product process development and GMP operations. It also provides oversight of the other GMP needs at the School of Medicine to ensure that proper operational controls, procedures, and systems are implemented and followed. This position supervises the work of the Director of Cellular GMP Operations and oversees the operational initiatives needed to effectively support research & development in cellular and gene therapies. APPLICATION INSTRUCTIONS Candidates should submit a letter of interest and a Curriculum Vitae to Jill Boy at jill.boy@duke.edu. Candidates who are selected to move forward should anticipate in-person interviews in late August/early September 2026. Review of applications will begin immediately and continue until the position is filled. For full consideration, materials should be received by August 7, 2026. PRINCIPAL RESPONSIBILITIES AND ACCOUNTABILITIES • Establish strategic plans for Duke’s Cellular and Gene Therapies and GMP operations. • Help to ensure that the goals and objectives of the School of Medicine and faculty GMP users are aligned with sponsored funding. • Collaborate and oversee the work of the Director of GMP Operations to optimize profitability in conjunction with short-term and long-term business strategies, goals, and objectives. • Provide leadership including advice, guidance, and direction on business matters, including operational policies and procedures, new business initiatives, and management of existing client relationships. • Foster a success-oriented and accountable environment. Recommend opportunities for enhancing operational efficiencies. • Develop plans for research and development pipelines for future products. • Actively contribute to new research and product development in support of Duke investigators. • Engineer the alignment of people, processes, policies, and assets to an optimal balance. • Identify and implement change initiatives throughout the organization that improve workflow and productivity. • Initiate and participate in strategic and tactical brainstorming sessions across all initiatives. • Collaborate with School of Medicine (SOM), Duke Cancer Institute, and other Duke Health leadership including but not limited to Divisional leadership for Pediatric Transplant and Cellular Therapy, Hematologic Malignancies and Cellular Therapy, and Pediatric Hematology-Oncology, to develop and implement plans for the operational infrastructure of systems, processes, and personnel designed to accommodate rapid growth objectives. • Review operating results, comparing them with established objectives, and recommend appropriate measures to enhance outcome. • Lead goal setting; monitor progress and assist with performance development; measure job performance. • Work closely and collaboratively with the SOM Office of Regulatory Affairs and Quality (ORAQ) to ensure GMP quality and FDA regulatory compliance, including proactive evaluation of organizational risks, alignment on risk tolerance, continuous review and response to key performance indicators (KPIs), and assurance that operations, documentation, and decision‑making meet high standards of quality and integrity for patient/product safety. REQUIRED QUALIFICATIONS Education/Training • Licensed physician (MD, DO) or PhD scientist with training in hematopoietic cell transplantation, cell and gene therapy, basic or clinical immunology, immunohematology, basic or clinical hematology, or transfusion medicine, with experience managing a GMP facility. Experience • 10–15 years of progressively responsible experience in transplantation medicine, cellular and gene therapy, regenerative medicine, GMP manufacturing, or related biologics/advanced therapeutics environments, with at least 5–7 years in a senior leadership or director‑level role; Previous supervisory experience is required. Skills • Relevant knowledge and industrial experience in the field of bioprocess development for manufacture of cellular and tissue-based therapies. • Experience transferring processes to cGMP facilities for commercial manufacture. • Experience successfully seeing a product through commercial FDA-licensure, as well as experience participating in FDA inspections and other regulatory, accreditation and sponsor audits. • Proven ability to lead organizational changes, optimize workflows, and implement scalable systems, processes, and infrastructure to support rapid changes and program expansion. • Experience managing budgets, forecasting operational needs, and aligning business strategies with scientific and clinical objectives. • Strong history of fostering a compliance driven, accountable, and collaborative culture within complex scientific or clinical operations. • Demonstrated experience overseeing GMP operations, including facility management, quality systems, regulatory compliance, and operational strategy within a cell therapy, tissue processing, or advanced therapeutics manufacturing unit. • Superb interpersonal and leadership skills, including the ability to build and maintain strong and collaborative relationships across Duke Health. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the position. It shall not be construed as a declaration of the total of the specific duties and responsibilities of the position. Other job-related responsibilities other than those specifically presented in this description may be expected. ABOUT DUKE UNIVERSITY AND DUKE HEALTH Duke University is a member of the Association of American Universities, and one of the most prestigious higher education institutions in the country, with 10 nationally prominent schools, including the Schools of Medicine and Nursing, and two affiliated international universities. Duke Health conceptually integrates the Duke University School of Medicine, Duke University Health System, Duke University School of Nursing, and Duke-NUS Medical School, as well as the Duke Global Health Institute, and schools and centers across Duke University, including the Duke-Robert J. Margolis Center for Health Policy. Duke University Health System advances the clinical mission by delivering care across four hospitals (Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, and Duke Health Lake Norman Hospital) and numerous outpatient services, including Duke Primary Care, Duke Home Care & Hospice, Duke Health and Wellness, and multiple affiliations. Duke Health Integrated Practice (DHIP) within Duke University Health System encompasses more than 3,100 clinicians and 2,200 nurses, clinical and administrative staff who care for patients in 2.7 million annual visits. Duke’s Office of Graduate Medical Education program includes more than 218 residency and fellowship programs and more than 1,190 trainees. Duke University School of Medicine is one of the nation’s leading medical schools and one of the largest biomedical research enterprises in the country. Led by Dean Mary E. Klotman, MD, who also serves as Executive Vice President for Health Affairs for Duke University and Chief Academic Officer for Duke Health, the school comprises more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff in 26 clinical and basic science departments. The school’s strong emphasis on research to improve clinical outcomes encourages collaboration and has resulted in the development of numerous centers and institutes including the Duke Clinical Research Institute, the world’s largest academic clinical research organization. The School of Medicine offers a wide range of medical and health professions programs, certificate and training programs, as well as biomedical sciences PhD programs which are administered in partnership with Duke’s Graduate School. 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 all perspectives, backgrounds, and experiences are valued and the contributions of all individuals are respected. All members of our community have a responsibility to uphold these values.Duke is an 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, ethnicity, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation, or military 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.
We are not accepting applications for this job through AcademicJobsOnline.Org right now. Please Candidates should submit a letter of interest and a Curriculum Vitae to Jill Boy at jill.boy@duke.edu..
- Contact: Jill Boy, +1 919-684-0921
- Email:
- Postal Mail:
- 203A Allen Building, Duke Box 90001, Durham, NC 27708
- Web Page: Candidates should submit a letter of interest and a Curriculum Vitae to Jill Boy at jill.boy@duke.edu.