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Doral

    Analytical Lab Manager - Doral, United States - BlueChew

    BlueChew
    BlueChew Doral, United States

    1 week ago

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    Description

    Overview

    We are a fast-growing healthcare technology company seeking an experienced Analytical Lab Manager who has previous experience spearheading the buildout of a new lab from the ground up and is ready to do it again, as well as support continuous operations thereafter.

    The ideal candidate will be based in/near Fort Lauderdale, FL and would be comfortable traveling on an as-needed to basis to pre-existing locations, including but not limited to the Chicago, IL area, where you will initially help develop an internal lab practice while simultaneously building out a new lab from scratch in Florida.

    Lab testing services will include API analysis, as well as pharmaceutical R&D functions.

    Responsibilities and Duties

    SOP Development:

    Develop SOPs, guidance, protocols, and reports that meet requirements of GMP and appropriate regulatory guidelines.

    Workflow Enhancement:

    • Develop and validate analytical methods for testing raw material and formulated pharmaceutical products in solid and liquid oral dosage forms.
    • Perform analytical testing using established in-house and USP analytical methods.

    Manage the day-to-day activities for all R&D method development, transfer, validation, early-phase formulation development, and finished product testing, including:

    • Assay, related substances, impurities, uniformity of dosage units, dissolution, residua solvents, loss-on-drying, microbial testing, cleaning verification and validation.
    • Container/closure testing and selection
    • Conduct stability-indicating studies per USP and ICH guidelines.
    • Perform installation qualification, operational and performance qualification for new instrumentation.

    Strategic Vision:

    • Spearhead both short- and long-term strategic planning for lab space, infrastructure, and data accessibility.
    • Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase and commission of analytical instrumentation.
    • Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
    • Stay current on publications released by USP, FDA, and other pertinent regulating bodies to ensure activities throughout the facility are compliant and continuously improved upon.

    Contract Service Strategy:

    • Formulate a comprehensive lab contract service strategy and establish agreements.

    Budget Oversight:

    • Manage budgets for service contracts, repairs, and equipment maintenance.
    • Implement efficient planning and scheduling to minimize equipment disruption.
    • Oversee asset life-cycle management with attention to budget efficiency.

    Staff Training and Competency:

    • Conduct thorough staff training and ensure the certification of competency.
    • Supervise work processes to guarantee precision and efficiency.

    Sample Management:

    • Ensure meticulous handling of testing samples from receipt to organization and preparation.
    • Address initial troubleshooting of testing issues and report problems promptly to leadership.

    QA/QC Compliance:

    • Ensure unwavering adherence to all QA/QC protocols and validate compliance.
    • Responsible for investigating and processing Deviations, Out-of-Specifications, Out-of-Trend, and QC events.
    • Possess a deep understanding of ISO 17025 standards, 21 CFR, US FDA guidance, ICH guidelines, and compendia requirements.

    Scientific Supplies Management:

    • Assist in developing and executing the best laboratory operations plan with a focus on scientific supplies management.

    Qualifications

    • Bachelors degree in Chemistry, Biochemistry, or equivalent.
    • At least 3-5 years of hands-on experience in biotech/pharmaceutical laboratories.
    • At least 3-5 years of theoretical and hands-on experience in various analytical techniques and instrumentations (HPLC, LCMS) for analytical development.
    • Previous experience in a licensed analytical product testing laboratory is highly desirable.
    • A collaborative team player with strong communication and interpersonal skills who is also comfortable working independently.
    • Excellent attention to detail and ability to maintain a high level of accuracy, while meeting deadlines for assigned projects.
    • Able to multi-task, prioritize and manage timelines in a fast-paced environment.
    • Must be able to lift at least 50 lbs.
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