Company overview
The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.
Job details
Exciting Opportunity at MSK: The Facility Manager is responsible for overseeing the daily operations of the Biotherapeutics core (BTC), ensuring GMP compliance, and supporting the production of clinical cellular products and other biotherapeutic modalities for Phase I/II clinical trials. In this role, you will lead a team of 5 staff scientists and manage key aspects of facility operations, quality assurance, and regulatory compliance.
Role Overview:
- Maintain GMP compliance for the facility and its operations.
- Oversee daily operations, including equipment validation, environmental monitoring, and raw material management.
- Lead a team of 5 staff members in facility operations, training, and process validation.
- Prepare for FDA inspections and support external audits.
- Review and support Batch Production Records (BPCR) and contribute to IND submissions.
- Manage budgets and invoices for the facility.
- Ensure proper gowning, personnel monitoring, and raw material quarantine procedures are followed.
- Oversee multi-user GMP operations, including production scheduling and facility turnover.
- Manage production scheduling, facility turnover, and equipment monitoring.
- Stay updated on developments in cell and gene therapies, cGMP, and clinical trials.
- Key Qualifications:
- Master’s degree in Life Sciences (or related field).
- 5-10 years in cGMP operations or laboratory management.
- Familiar with quality assurance principles and FDA regulations.
- Strong leadership and team management skills.
- Excellent communication and organizational skills.
- Project management experience, especially in GMP environments.
- Ability to manage multiple tasks and priorities effectively.
Core Skills:
- GMP Compliance and Regulatory Knowledge.
- Team Leadership and Facility Operations.
- Quality Assurance and Audit Preparation.
- Budgeting and Financial Management.
Additional Information:
- Location: 417 East 68th St. (Zuckerman)
- Schedule: 37.5 hours, onsite
- Reporting to: Associate Lab Director
Pay Range: $109,300.00-$174,800.00
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Application Process
Biotherapeutics Core Facility Manager
Department:Research - Laboratory
Location: New York, NY