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    Manufacturing Associate/Sr. Associate - Orange County, United States - BioPhase Solutions

    BioPhase Solutions
    BioPhase Solutions Orange County, United States

    4 days ago

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    Description

    Job Description

    Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Manufacturing Associate/Sr. Associate (Downstream) to work for a leading Orange County area contract manufacturing company.
    Pay Rate: $50-70k depending on experience.
    This role is a full-time, non-exempt position. Flexible schedule due to operations/scheduling.
    • Work overtime and weekends as necessary
    • Shift work: Sun-Wed or Wed-Sat, 4 days x 10 hours
    Summary:The Manufacturing Associate/Sr. Associate performs Product Manufacturing tasks or provides Manufacturing Support in strict compliance with cGMP, under Standard Operating Procedures in a multi-product manufacturing facility, including, but not limited to: production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate will play an integral role in ensuring the production and on-time release of quality products.Responsibilities:
    • Ensure equipment and materials are in place as required for each production run
    • Plan and prepare needs for processes and activities
    • Operate and maintain BioProcess chromatography skid
    • Pack, unpack, and clean production scale chromatography columns
    • Antibody and enzyme purification via Affinity chromatography, Size Exclusion chromatography, Ion Exchange chromatography, Hydrophobic Interaction and Tangential Flow Filtration (TFF)
    • pH and conductivity meter calibration and testing
    • Product filtration (sterile filtration, ultrafiltration, viral filtration)
    • Aseptic technique utilizing excellent hand skills with slow, deliberate movement
    • Product filling (aseptic processing including media fill qualifications)
    • Maintain and clean cleanroom facility and equipment
    • Control and track raw material inventory
    • GMP documentation
    • Revise and initiate Batch Production Records, Standard Operation Procedures, study protocols and reports
    • Lead independent projects as assigned
    Other Duties:
    • Prepare media and buffer solutions
    • Manually clean small parts and equipment
    • Filter integrity testing utilizing Sartocheck 3/4 Filter Integrity Tester
    • Operate and maintain ARS Frontier Autoclave
    • Operate and maintain Gruenberg Oven
    • Perform daily monitoring of equipment
    • Prepare glassware and equipment for production
    Qualifications:
    • Bachelors degree in a life sciences discipline required
    • A minimum of one to two years (three to four years for Sr. level) related life sciences industry experience
    • Need two years of experience working with large scale liquid chromatography columns or similar equipment
    • Require experience working in a GMP production environment with aseptic technique
    • Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment
    Please send resumes to and visit our website at for additional job opportunities
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