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Program Manager, GCTI Manufacturing
Program Manager, GCTI ManufacturingMass General Brigham (Enterprise Services) • Cambridge, MA, US
Program Manager, GCTI Manufacturing

Program Manager, GCTI Manufacturing

Mass General Brigham (Enterprise Services) • Cambridge, MA, US
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Overview

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.

Responsibilities

  • 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.
  • 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.
  • 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.
  • Write comprehensive technical reports, development plans, study plans, technical transfer protocols and detailed protocols based on 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.
  • 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.
  • All other tasks as needed or assigned by supervisor.

    • Qualifications

  • Bachelor\'s Degree in related field 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 ability to manage with influence without direct authority.
  • Self-starter with a strong desire to contribute and work collaboratively to achieve goals.
  • Comfortable working in 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.

    • 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.

    • Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.

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