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    MANUFACTURING ASSOCIATE 1 or 2 - San Diego, United States - Capricor Inc

    Capricor Inc
    Capricor Inc San Diego, United States

    2 weeks ago

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    Description

    Job Description

    Job Description

    Position: Manufacturing Associate I/II

    This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support Capricor's clinical trials and exosome development. We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.

    Responsibilities:

    • Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
    • Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
    • Compiling data for documentation of test procedures and reporting abnormalities
    • Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
    • Authoring, revising and updating standard operating procedures using the document change system
    • Maintaining broad knowledge of state-of-the-art principles and theories
    • Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations
    • Preparing technical summaries, protocols and reports
    • Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
    • Performing special manufacturing and development projects

    Requirements:

    • Bachelor's degree in Biomedical Engineering, Biological Sciences or related field
    • 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
    • Laboratory experience in mammalian tissue culture is required
    • Excellent aseptic technique, knowledge of aseptic practices
    • Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
    • Exceptional communication and interpersonal skills
    • Excellent organizational skills and attention to detail
    • Ability to work in a dynamic environment
    • Basic molecular biological and flow cytometry skills are preferred
    • Adaptable/flexible with work schedule with an ability to multi-task and prioritize work

    Work Environment/Physical Demands:

    • Must be able to sit and stand for extended periods.
    • Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.
    • Able to fully gown and work in a manufacturing area.
    • Work extended or off hours depending on the company needs to respond to manufacturing schedule (including weekends, holidays), as required
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