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2 Affinity Group Michaels Jobs

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    Pharmaceutical Manufacturing Technician

    Latitude, Inc.
    Gaithersburg, MD 20877
    Full-time, Part-time
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    Job Description

    Job Description

    Job Type: Full-time

    Pay: $25.00 - $37.00 per hour

    The Pharmaceutical Manufacturing Technician role is critical to our patients. Manufacturing life-saving medicines right the first time for themselves and their team with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!

    The Role:

    • Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
    • Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports
    • May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
    • Generate and revise internal and external documents (SOPs, BRs)
    • Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
    • Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
    • Recommend equipment and other supply purchases within the production areas
    • Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
    • Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
    • Work closely with various departments and aid other teams as necessary
    • Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
    • Participate in facility expansion and equipment validation activities
    • Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines

    Downstream:

    • Leverages knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of proteins, antibodies, etc. for Phase I/II GMP manufacturing
    • Works closely with purification management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives
    • Perform buffer preparations, in-process sampling, formulation of bulk drug substance
    • Conducts changeover and activation procedures for clean room suites and equipment
    • Submits in-process and cleaning samples to Quality Control with required documentation
    • Has excellent understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes
    • Extensive experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)

    Requirements:

    • Bachelor’s degree in a Scientific, Engineering or Biotech field with 1-3 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

     

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    Posting ID: 593964642Posted: 2021-01-19