Director, GMP Shared Resource, Sloan Kettering Institute of MSK

Memorial Sloan Kettering Cancer Center (MSKCC) is seeking a Director for the GMP Shared Resource Facility. This faculty position is fully supported by the institution and provides strategic leadership and operational oversight for a shared, hoteling-based manufacturing and quality control environment.

The Director is responsible for ensuring that all manufacturing suites and associated QC/analytical operations operates and are maintained in a continuous state of inspection readiness, meeting all regulatory, cGMP and institutional safety requirements while advancing operational efficiency and scientific innovation.

This role requires a highly experienced leader capable of integrating cutting edge science, operational rigor, quality and compliance, within a complex shared-resource environment.

• Oversee day-to-day operations of the GMP shared resource facility, including:
  Facility maintenance, environmental monitoring and suite readiness Equipment maintenance, qualification, and lifecycle management Raw material sourcing, qualification and inventory management

• Provide strategic and technical leadership of all QC and analytical operations, positioning the function as a central enabler of product release and regulatory compliance Establish and maintain a phase-appropriate, risk-based analytical control strategy across multiple product modalities (e.g., cell therapies, viral vectors, biologics) Oversee:
  Assay development, qualification, validation, and lifecycle management In-process, release, and stability testing programs Method transfer, comparability, and bridging strategies for evolving processes

Ensure all analytical methods are:
Scientifically rigorous and fit-for-purpose Fully compliant with cGMP and data integrity standards Scalable and adaptable to emerging technologies and product platforms Build and maintain robust analytical infrastructure and capabilities, including:
Instrumentation strategy and platform standardization Reference standards and critical reagents Trending, statistical analysis, and data review systems Drive timely and compliant batch disposition by ensuring QC readiness aligns with manufacturing timelines Collaborate closely with MSK research laboratories to translate early-stage assays into GMP-compliant methods

• Partner with MSK’s Clinical Research Quality Assurance unit to:
  Maintain documentation and ensure regulatory compliance Oversee and maintain core quality systems, including deviations, CAPA, change Control and Document management. Drive continuous improvement of the Quality Management System (QMS)

Ensure continuous inspection readiness and serve as the primary subject matter expert during regulatory audits and user inspections

• Develop long-term operational strategies aligned with institutional needs Manage infrastructure and operating budgets Establish sustainable models to support facility growth and evolving demand

• Recruit, train, and mentor a multidisciplinary team Foster a high-performing, inclusive culture grounded in integrity and accountability

• Build and maintain strong, collaborative relationships across MSK, including research, clinical, and quality organizations Serve as a key liaison between GMP operations and internal and external stakeholders Communicate proactively regarding operational readiness, risks, and strategic initiatives

Applicants should have  life sciences and substantial (10+ years) GMP experience in a leadership role.

MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. Women and minority candidates are strongly encouraged to apply.

Memorial Sloan Kettering Cancer Center (MSKCC) seeks a Director for the GMP Shared Resource Facility within the Sloan Kettering Institute. This role provides strategic leadership and operational oversight of a shared, hoteling-based GMP manufacturing and quality control environment. The Director ensures continuous inspection…