Cedars-Sinai Job - 30098536 | CareerArc
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Company: Cedars-Sinai
Location: Los Angeles, CA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Cedars-Sinai is developing a state-of-the art new biomanufacturing facility called the Cedars-Sinai Biomanufacturing Center (CBC)!


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


The CBC is currently seeking a Manager, cGMP Manufacturing to manage and provide leadership for the overall achievement of production, quality, cost, and safety standards of assigned cGMP cell manufacturing areas in accordance with current Good Manufacturing Practice (cGMP) and SOPs.


Additional Responsibilities:

  • Manages product development and manufacturing of cell-based therapeutic products in a sterile product manufacturing and packaging environment
  • Supervises production staff
  • Manages development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products

  • Develops and implements scale-up/optimization methods for cell production to ensure maximum throughput, assisting in troubleshooting manufacturing problems, generating and maintaining manufacturing equipment operational SOPs
  • Ensures safe, compliant, and manageable cGMP operations and continuing validation and operations of a cGMP manufacturing facility
  • Oversees development, implementation, and maintenance activities of quality control systems
  • Provides leadership on operational and strategic plans
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Educational Requirements:

  • Bachelor's degree in Biology or related life science required
  • Master's degree or PhD preferred

Experience and Skillset:

  • Experience in production of cell therapy, car-T, iPSC
  • Minimum of eight (8) years experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
  • Minimum of three (3) years experience in GMP production supervisory or leadership position
  • Minimum of three (3) years experience in tissue culture techniques, processing 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

Physical Demands:

  • Minimal lifting and walking


 Apply on company website