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Program Manager, GCTI Manufacturing
Mass General BrighamUnited Statesfull_timeVerifiedPosted 5 Sept 2025
About the role
Site: Mass General Brigham Incorporated
We are seeking a strategic, experienced, and mission-driven Program Manager to help lead the operational, scientific, and translational components of the Institute’s growing portfolio. This individual will manage cross-functional programs, coordinate with internal and external stakeholders, and play a critical role in overseeing the development, execution, and evaluation of GCTI-supported gene and cell therapy initiatives
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1) MANUFACTURING PROGRAM MANAGEMENT
• Lead the end-to-end management of GCTI-sponsored gene and cell therapy programs, including tracking progress toward scientific, translational, and commercial milestones.
• Serve as the central liaison among investigators, Core Directors, clinical teams, regulatory experts, industry partners, and internal leadership.
• Collaborate with scientific and technical leaders to support research and GMP gene and cell therapy production campaigns.
• Coordinate project timelines, budgets, resource allocation, and risk mitigation strategies across multiple concurrent manufacturing programs.
• Oversee cross-departmental collaboration, ensuring alignment of scientific priorities with regulatory, quality, and operational frameworks.
• Support the translation of research-grade products to clinical-grade manufacturing processes in collaboration with GMP and research Core stakeholders.
2) REGULATORY & TRANSLATIONAL MANAGEMENT
• Manage CMC preparation and review of regulatory submissions (e.g., INDs, briefing documents, pre-IND materials) in collaboration with the regulatory team.
• Track regulatory timelines and deliverables across program lifecycles and maintain clear, auditable documentation.
• Guide investigators on translational manufacturing and CMC requirements, and best practices for preclinical development and clinical readiness.
3) MANUFACTURING CORE & GMP SUPPORT
• Oversee harmonization of gene and cell therapy production unit operations at research and GMP Cores at MGB.
• Support Core management with establishment of Standard Operating Procedures.
• Provide programmatic support of analytical assay development, process optimization, and production scalability initiatives.
• Manage strategic investments in infrastructure, equipment, and talent to support Core facility growth and evolving needs.
• Manage long-range facility planning in consultation with GCTI senior leadership, scheduling, and projections.
• Interfacing with and providing technical expertise to the Operations and Quality groups.
• Writing comprehensive technical reports, development plans, study plans, technical transfer protocols and detailed protocols based on the results from PD and/or manufacturing campaigns for internal leadership and funding sponsors.
• Analyze and report Core production metrics as needed.
• Support the Core Directors as needed.
4) ADMINISTRATIVE MANAGEMENT
• Collaborate with a team of program and project managers, scientists, and administrative staff in alignment with GCTI and Institute priorities.
• Support budget planning, reporting, and long-range strategic initiatives in partnership with GCTI senior leadership.
5) All other tasks as needed or assigned by supervisor.
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
The Gene and Cell Therapy Institute (GCTI) is a newly launched, system-wide initiative within Mass General Brigham (MGB), designed to accelerate the translation of cutting-edge gene and cell therapy research into transformative clinical applications. GCTI fosters a unified ecosystem to support investigators across MGB, advancing platforms and programs that aim to deliver next-generation therapeutics to patients. Leveraging the unique strengths of a world-class academic hospital network, GCTI positions MGB as a global leader in gene and cell therapy innovation.We are seeking a strategic, experienced, and mission-driven Program Manager to help lead the operational, scientific, and translational components of the Institute’s growing portfolio. This individual will manage cross-functional programs, coordinate with internal and external stakeholders, and play a critical role in overseeing the development, execution, and evaluation of GCTI-supported gene and cell therapy initiatives
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1) MANUFACTURING PROGRAM MANAGEMENT
• Lead the end-to-end management of GCTI-sponsored gene and cell therapy programs, including tracking progress toward scientific, translational, and commercial milestones.
• Serve as the central liaison among investigators, Core Directors, clinical teams, regulatory experts, industry partners, and internal leadership.
• Collaborate with scientific and technical leaders to support research and GMP gene and cell therapy production campaigns.
• Coordinate project timelines, budgets, resource allocation, and risk mitigation strategies across multiple concurrent manufacturing programs.
• Oversee cross-departmental collaboration, ensuring alignment of scientific priorities with regulatory, quality, and operational frameworks.
• Support the translation of research-grade products to clinical-grade manufacturing processes in collaboration with GMP and research Core stakeholders.
2) REGULATORY & TRANSLATIONAL MANAGEMENT
• Manage CMC preparation and review of regulatory submissions (e.g., INDs, briefing documents, pre-IND materials) in collaboration with the regulatory team.
• Track regulatory timelines and deliverables across program lifecycles and maintain clear, auditable documentation.
• Guide investigators on translational manufacturing and CMC requirements, and best practices for preclinical development and clinical readiness.
3) MANUFACTURING CORE & GMP SUPPORT
• Oversee harmonization of gene and cell therapy production unit operations at research and GMP Cores at MGB.
• Support Core management with establishment of Standard Operating Procedures.
• Provide programmatic support of analytical assay development, process optimization, and production scalability initiatives.
• Manage strategic investments in infrastructure, equipment, and talent to support Core facility growth and evolving needs.
• Manage long-range facility planning in consultation with GCTI senior leadership, scheduling, and projections.
• Interfacing with and providing technical expertise to the Operations and Quality groups.
• Writing comprehensive technical reports, development plans, study plans, technical transfer protocols and detailed protocols based on the results from PD and/or manufacturing campaigns for internal leadership and funding sponsors.
• Analyze and report Core production metrics as needed.
• Support the Core Directors as needed.
4) ADMINISTRATIVE MANAGEMENT
• Collaborate with a team of program and project managers, scientists, and administrative staff in alignment with GCTI and Institute priorities.
• Support budget planning, reporting, and long-range strategic initiatives in partnership with GCTI senior leadership.
5) All other tasks as needed or assigned by supervisor.
Qualifications
Qualifications
- Bachelor's Degree Related Field of Study required; PhD or MS with equivalent experience in life sciences, bioengineering, molecular biology, or related fields highly preferred
- At least 5-7 years of Program Management Experience required
- At least 1-2 years of Supervisory/Team Leadership Experience required
- At least 5 years of relevant experience in gene therapy, cell thera
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