Manager, Cell Therapy and Cell Engineering Facility (CTCEF)
Memorial Sloan-Kettering Cancer Center
April 29, 2018
New York, New York
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The Operations and QA Manager, Cell Therapy and Cell Engineering Facility (CTCEF) directs, plans and actively participates in daily functions of the Cell Therapy and Cell Engineering Facility to ensure efficient and effective operations and compliance with all aspects of quality assurance and facility operations in a highly regulated environment. The CTCEF is responsible for the production of clinical cellular products for Phase I/II clinical trials.
Responsible for maintaining the CTCEF facility in GMP compliance
Supervises a team of 5 staff members who operate the facility, including the facility manager
Oversees gowning and personnel monitoring procedures
Oversees environmental monitoring procedures
Oversees operation and validation of equipment
Oversees qualification and quarantine of raw material
Oversees the database for the management and inventory of raw materials and clinical products.
Oversees and contributes to inspections, audits and certification of suppliers
Oversees and coordinates the multi-user GMP facility operations
Oversees the integration of multi-users raw material inventory supplies for manufacturing
Oversees production scheduling and facility turnover (e.g cleaning, room and equipment certifications)
Oversees the Equipment monitoring alarm 24/7 (> 400 units) including on-site and off-site storage of cellular clinical products
Responsible for developing and maintaining the CTCEF quality management system to ensure that the facility and processes are compliant with cGMP/FDA regulations.
Supervises one Technical writer who operates MasterControl
Develops and maintains the CTCEF quality manual
Develops and maintains the CTCEF quality management system to ensure facility and processes compliance with current 21CFR/FDA regulations and FACT/ Immune Effector Cells regulations
Oversees operation and maintenance of MasterControl: controlled documentation life cycle (e.g SOPs, MPCRs), training, deviation, change control, quality improvement, validation, audit
Oversees completion and documentation of training and on-going competency
Oversees and supports non-compliances
Prepares the facility for external audit
Oversees and conducts internal audits
Insures readiness of facility for FDA inspections
Contributes to Gene Transfer and Somatic Cell Engineering (GTF) user group production runs related documentation
Supervises a team of 2 staff members who coordinate production runs and related compliant documentation
Supports issuance of Batch Production and Controlled Records (BPCR)
Supports and coordinates the assembly, timely completion and reviewing of the BPCR
Contributes to MPCR approval
Development and implementation of new manufacturing procedures
Liaise with the Director, the Production manager and the Research and Technology Mgmt group for effective integration and FDA compliance of new procedures in the core facility.
Assists production teams with process qualifications and validations documentation
Contributes to the preparation of documents including the CMC section of INDs submitted to the FDA
Delivery of cellular products for infusion of cellular products
Helps the QA Coordinator, QC and Production staff members to coordinate tthe release and delivery of cellular products to the hospital staff in compliance with FACT/IEC regulations
Prepares budgets, chargeback invoices, facility user invoices and helps establish contract manufacturing services
Master's Degree with 5-10 years of related experience in cGMP operations, laboratory management or work in controlled therapeutic manufacturing environments is highly preferred.
Applicants must be familiar with the principles of quality assurance and FDA regulations. excellent communication, interpersonal skills and organizational skills
team leader, strong supervisory and leadership skills
equipment qualification and validation
writing reports and computer software skills
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. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
Internal Number: 8249813
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.