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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 Home - CSBIO (csbiomfg.com).

The GMP Manager manages and provides leadership for overall achievement of production, quality, cost, and safety standards of assigned cGMP cell manufacturing areas in accordance to current Good Manufacturing Practice (cGMP) and SOPs. You will manage product development and manufacturing of cell based therapeutic products in a sterile product manufacturing and packaging environment and supervises production staff, development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, and accuracy and reliability of company products.

The GMP Manager develops and implements scale-up/optimization methods for cell production to ensure maximum throughput, assisting in troubleshooting manufacturing problems, and generating and maintaining manufacturing equipment operational SOPs. You will ensure safe, compliant and manageable cGMP operations and continuing validation and operations of a cGMP manufacturing facility, and oversee the development, implementation, and maintenance activities of quality control systems.

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Primary Duties & Responsibilities:

• Ensures safe, compliant and manageable cGMP operations and continuing validation of operations of cGMP manufacturing facility.
• Manages development, implementation, and maintenance activities of quality control systems.
• Responsible for hiring, onboarding, managing schedules, personnel actions, performance reviews, and performance improvement plans.
• Supervises the day-to-day work of employees, assigns work, ensures tasks are completed and deadlines are met.

Education:

• Bachelor's Degree in Biology or Life Science is required. Master's Degree is preferred.

Experience and Skills:

• Eight (8) years of biologics experience, preferably in cell therapy, development environment, preferably manufacturing development for cell therapy products.
• Three (3) years of leadership experience overseeing line function teams or project teams with human cell culture, aseptic processing, GMPs, cell-based analytical methods. Managing hands-on manufacturing operations.
• Experience in tissue culture techniques; the processing of human cells at large scale; processing and analyses of human specimens; cell staining and flow cytometry.
• Knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards.
• Ability to analyze, project and adjust staffing to meet workforce planning needs.
• Ability to translate strategic thinking into operational objectives and plans.
• Ability to address performance issues and implement corrective action plans.
• Demonstrates problem solving skills and recommends solutions.
• Promotes and fosters participation/collaboration among individuals and groups.
• Provides and/or supports a level of work excellence and accuracy; recognizes and addresses flaws or errors that others may overlook.
• Applies advanced knowledge of science/learning/specialized intellectual instruction to analyze, interpret or make deductions from varying facts or circumstances.