Program Director of Manufacturing

KEY RESPONSIBILITIES:

1. Program Management & Strategic Operations

• 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.

• Coordinate project timelines, budgets, resource allocation, and risk mitigation strategies across multiple concurrent programs.

• Support the translation of research-grade products to clinical-grade manufacturing processes in collaboration with GMP and Research Core stakeholders.

• Oversee cross-departmental collaboration, ensuring alignment of scientific priorities with regulatory, quality, and operational frameworks.

2. GMP & Research Core Oversight (Programmatic Role)

• Collaborate with scientific and technical leaders to support ongoing viral vector and cell therapy production campaigns.

• Provide programmatic oversight of analytical assay development, process optimization, and production scalability initiatives.

• Align research and GMP activities with regulatory requirements, quality standards, and long-term Institute goals.

• Coordinate strategic investments in infrastructure, equipment, and talent to support Core facility growth and evolving needs.

3. Regulatory & Translational Strategy

• Provide comprehensive support in the preparation and review of regulatory submissions, including Investigational New Drug (IND) applications, briefing documents, and pre-IND materials, in close collaboration with the regulatory team.

• Monitor and ensure adherence to regulatory timelines and deliverables across the program lifecycle, maintaining precise and auditable documentation.

• Advise investigators on translational requirements and established best practices to facilitate preclinical development and readiness for clinical application.

4. Administrative and People Management

• Supervise and provide guidance to a team of program managers, project managers, scientists, and administrative personnel, ensuring alignment with the strategic priorities of the Institute.

• Facilitate processes related to recruitment, performance evaluation, and professional development initiatives.

• Prepare and present detailed technical reports, development plans, and progress summaries for internal leadership and funding entities.

• Assist in budget planning, financial reporting, and the formulation of comprehensive long-term strategic initiatives in collaboration with senior leadership at GCTI.

5. Stakeholder Engagement & Communication

• Build strong partnerships across MGB hospitals, departments, and academic centers.

• Represent GCTI in cross-institutional committees, program reviews, and partner meetings.

• Communicate program impact, goals, and key performance indicators clearly and regularly to stakeholders.

QUALIFICATIONS:

• PhD or MSwith equivalent experience in life sciences, bioengineering, molecular biology, or related fields.

• Minimum of 10 yearsof relevant experience in gene therapy, cell therapy, viral vector development, or biologics program management.

• Demonstrated leadership incross-functional program or portfolio management, particularly in translational or early-stage development environments.

• Familiarity withGMP manufacturing, assay development, and quality/regulatory processes.

• Strong understanding ofclinical developmentandcommercialization pathwaysfor advanced therapies.

• Experience inacademic and/or industry settings, preferably within a matrixed or multi-site institution.

• Excellentcommunication, strategic planning, and interpersonal skills; capable of working with technical and non-technical stakeholders.

PREFERRED SKILLS:

• Extensive knowledge in technology transfer and intellectual property strategy within the domain of biomedical innovation.

• Demonstrated experience managing programs funded by major federal agencies such as the NIH or FDA, as well as philanthropic organizations.

• Proficiency in conducting IND-enabling studies, understanding regulatory science, and navigating the evolving policies surrounding gene and cell therapy.

• A proven record of collaborative work within core facilities, academic research institutions, or translational research settings.

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.