Program Manager, GCTI Manufacturing chez Mass General Brigham
Mass General Brigham · Cambridge, États-Unis d'Amérique · Onsite
- Professional
- Bureau à Cambridge
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.Onsite65 Landsdowne Street40RegularDay (United States of America)Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
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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 therapy, viral vector development, or biologics program management highly preferred
- Demonstrated leadership in cross-functional program or portfolio management, particularly in translational or early-stage development environments.
- Familiarity with GMP manufacturing, assay development, and quality/regulatory processes.
- Strong understanding of clinical development and commercialization pathways for advanced therapies.
- Experience in academic and/or industry settings, preferably within a matrixed or multi-site institution.
- Excellent communication, strategic planning, and interpersonal skills; capable of working with technical and non-technical stakeholders.
Knowledge, Skills, and Abilities
- Highly functioning, detail-oriented, and analytical candidate who can think strategically and holistically about organizational expansion and across multiple departments/units.
- Proven experience in early stage biologics process development, manufacturing, and process characterization
- Demonstrated ability to function in a collaborative quality and CMC environment.
- Demonstrated ability to generate and finalize Standard Operating Procedures, corresponding Forms, and other manufacturing and analytical protocols.
- Knowledge of technology transfer and IP strategy in biomedical innovation.
- Experience managing programs funded by NIH, FDA, or other major federal or philanthropic agencies.
- Familiarity with IND-enabling studies, regulatory science, and the evolving landscape of gene/cell therapy policy.
- Proven track record of working in or with core facilities, academic research centers, or translational research environments
- Strong communication skills and ability to connect at all levels of the organization.
- Proven manage with ability to influence others without direct authority.
- Self-starter but also a strong desire to contribute and work collaboratively to achieve goals.
- Must be comfortable working within an evolving, sometimes ambiguous environment/structure.
- Ability to handle sensitive and confidential information required.
- Experience with quality systems preferred.
- Familiarity with the commercialization of research innovations is preferred.
Additional Job Details (if applicable)
WORKING CONDITIONS:
Mandatory onsite role; position may require travel to MGB hospitals and affiliated sites.
Occasional off-hours meetings with partners or collaborators may be required.
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
- /
Grade
7
EEO Statement:
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
