Manager, Quality Control - Biomanufacturing Center

With your help, we can change the future of healthcare!

The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease.

To learn more about the CBC, please visit: https://www.cedars-sinai.org/research/areas/biomanufacturing/about.html

Are you ready to be a part of groundbreaking research?

The Quality Control (QC) Manager will provide quality control oversight of clinical manufacturing of final cell products and stage appropriate validation of analytical methods for cell therapy products. As a QC Manager, this role will be responsible for environmental monitoring, raw material testing, in-process and final product testing as well as for the purchase, installation and qualification of QC instrumentation. Additionally, the QC manager is responsible for establishing user requirements for purchase and qualification for analytical equipment, working with internal and external resources to maintain equipment in an optimal state. Review records and issue COAs for product release and develop, revise and review SOPs. Responsible for OOS investigations and participate in deviation investigations. The QC Manager will make certain that manufacturing performs efficiently, coordinate employee efforts when necessary, and facilitate communications between management and production departments.

Primary Job Duties and Responsibilities:

• Lead and monitor the development of any needed (or future) QC method validation.
• Oversee and/or perform sterility, endotoxin and mycoplasma testing, cell counts, and viability testing to ensure samples are within the established acceptance criteria.
• Verify packaging and document the shipment of all outgoing stem cell and related products.
• Review all QC testing data and related calculations. Maintain all paper and electronic documents and logs associated with QC testing.
• Issue Certificates of Analysis (CoA) for all outgoing stem cell and related products.
• Train and qualify laboratory personnel to perform their assigned laboratory duties. Manage inventory and order all supplies needed in QC.
• Maintain a full understanding of the Standard Operating Procedures (SOPs) and cGMP guidelines, applying them as required. Assist in the development and writing of SOPs, as necessary.
• Familiarity with 21 CFR Part 210 & 211 procedures.
• Solve problems by examining and evaluating data, as well as implementing corrective action when necessary.
• Attend and participate in group and project meetings.
• Monitor expenditures related to QC activities and programs and assist in budget preparation.
• Enhance laboratory and organizational effectiveness by accepting responsibility for accomplishing laboratory operational goals and doing so with the highest quality and integrity.
• Responsible for third-party laboratories executing QC tests for CBC products.
• In charge of any deviations/investigations that may occur in QC.
• In charge of OOS investigations; Trending Environmental Monitoring data; Follow USP monographs and be up to date to new analytical techniques.
• Performs all other duties as assigned.