• Manager, Cell Therapy and Cell Engineering Facility (CTCEF)

    Job Locations USA-NY-New York
    Posted Date 3 weeks ago(5/31/2018 2:38 PM)
    Requisition ID
    2018-21628
    Category
    Research - Laboratory
  • Company Overview

    At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
     
    For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.

    Job Description

    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.

     

    You will:

    • 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 facility user’s qualifications (e.g training, workflow, reagents qualifications, SOPs, process validations)
      • 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

     

    You have:

    • 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
    • project management
    • equipment qualification and validation
    • writing reports and computer software skills #LI-SB1

    Closing

     

    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.

     

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