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About the Role

The Director for the GMP Shared Resource Facility provides strategic leadership and operational oversight of a shared, hoteling-based GMP manufacturing and quality control environment. This role ensures continuous inspection readiness, meets regulatory and safety requirements, and advances efficiency and innovation. This is a laboratory-track faculty position fully supported by the institution.

Responsibilities

• Oversees daily facility operations, including maintenance, environmental monitoring, suite readiness, equipment lifecycle management, and raw material sourcing and control.
• Ensures suites are properly configured and compliant for GMP activities.
• Supports technology transfer and onboarding of new processes.
• Leads quality control and analytical functions to enable product release and regulatory compliance.
• Establishes a risk-based analytical control strategy across modalities such as cell therapies, viral vectors, and biologics.
• Oversees assay development and validation, in-process and release testing, stability programs, and method transfer.
• Builds analytical infrastructure and ensures timely, compliant batch testing aligned with manufacturing timelines.
• Partners with Clinical Research Quality Assurance to oversee quality systems (deviations, CAPA, change control, document management) and maintain inspection readiness.
• Serves as a key subject matter expert during audits.
• Manages long-term operational planning, budget management, and development of scalable models to support facility growth.
• Manages finances and personnel, including hiring, training, and staff development.
• Collaborates cross-functionally across research, clinical, and quality teams.

Requirements

• Must hold an MD or PhD in Biological Sciences.
• At least 10 years of relevant experience in academic or industry settings.
• Required expertise includes investigational and clinical manufacturing (particularly immuno-oncology), regulatory submissions, and advanced product testing.
• Strong leadership and communication skills are essential.
• Experience managing large, multiuser core facilities is highly desirable.

Skills

• GMP manufacturing
• Quality control
• Regulatory compliance
• Risk-based analytical control strategy
• Assay development and validation
• Method transfer
• Quality systems management
• Budget management
• Personnel management
• Cross-functional collaboration

Location

• New York, NY

Work Type

• Full-time
• Exempt

Experience Level

• Director level
• 10+ years of experience

Education Level

• MD or PhD in Biological Sciences

Salary/Compensations

• $125,000-$300,000

About the Company

• The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life.
• MSK provides specialized care teams offering personalized, compassionate, expert care to patients of all ages.
• MSK conducts innovative translational and clinical research driven by basic research from the Sloan Kettering Institute.
• MSK is dedicated to training the next generation of scientists and clinicians.

Equal Opportunity

• MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment.
• All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
• Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities.
• Please tell us if you require a reasonable accommodation to apply for a job or to perform your job.