Operation Specialist

We are seeking a highly skilled and motivated Operation Specialist to join the COUR Operations Team. COUR is a clinical-stage biopharmaceutical company located in Skokie, Illinois with the goal of developing first-in-class innovative therapeutic products designed to reprogram the immune system to treat autoimmune disorders from pre-clinical development through FDA approval and commercialization.  In this role, you will be responsible for supporting the Operations team by implementing and executing manufacturing processes in a regulated, controlled environment.

  • Support the Operations team in drug substance and/or drug product manufacturing.
  • Help draft technical documentation for drug product manufacturing.
  • Assist the Operations team with equipment maintenance and testing, calibration and cleaning programs
  • Assist with shipping processes, which includes preparing cold-chain shipments, maintaining supply inventory, preparing documentation and updating logs.
  • Maintain manufacturing areas and process components to ensure a clean, safe and organized work environment
  • Work collaboratively with and support the Development Lab and Quality teams.
  • Follow standard operation procedures (SOP) and work instructions to execute tasks.
Education, Qualifications and Experiences
  • Experience working in manufacturing or laboratory operations is required.
  • Able to work in a clean room environment environment is required.
  • Pharmaceutical or Medical Device industry experience is preferred.
  • Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
  • Must be well organized, attentive to detail and have effective verbal and written communication skills.
  • Must be able to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.

COUR is a rapidly growing biotech company in the Chicagoland area that develops therapeutic products based on our deep knowledge of immunology and material science. Our team combines the skills and experience of biologists, material scientists, chemists, and engineers. COUR is expanding its laboratory and manufacturing capabilities at the Illinois Science + Technology Park, located at 8045 North Lamon Avenue in Skokie, Illinois. COUR is an Equal Opportunity Employer.

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