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    Manufacturing Specialist - Fremont, United States - Astrix

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    Manufacturing / Mechanical
    Description

    Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Manufacturing Specialist to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference

    Job Duties:

    • Independently executes all routine unit operations in Purification including change-over procedures, scheduling within the shift team, equipment cleaning and set up.
    • Able to perform in-process testing such as cell counting, spectrophotometry and environmental monitoring.
    • Monitors and controls weights, flows, volumes, temperatures, pressure, and pH.
    • Identify and report any issues related to manufacturing performance, process and safety to the team lead and assist in investigations of deviations in order to facilitate continuous process improvement.
    • Train junior staff on unit operations such as bioreactors, cell separation, chromatography and tangential flow theory as well as CIP/SIP operations.
    • All training will be conducted with an emphasis on safety and completion of operations in a timely manner.
    • Collaborates within team and department in order to follow best practices and meet department goals.
    • Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.
    • Responsible for processing in an aseptic clean room environment utilizing virus and cell culture techniques according to USDA regulations
    • Execute processes adhering to the Standard Operating Procedures Complete documentation concurrently Support cross-functional activities as required

    Job Requirements:

    • Experience working with established GMP procedures and bulk manufacturing.
    • Technical knowledge of manufacturing systems, methods, and procedures.
    • High school diploma or equivalent. Preferred B.S. in Biology or relevant field, laboratory experience/manufacturing experience


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