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    Production Director - Mississauga, ON, Canada - EightSix Network Inc

    EightSix Network Inc
    EightSix Network Inc Mississauga, ON, Canada

    2 weeks ago

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    Description

    Pharma Medica Research (PMRI) is a Contract Research Organization dedicated to fostering innovation and creative solutions in a challenging and competitive industry.

    We are a comprehensive contract research organization that specializes in conducting early phase clinical trials involving healthy volunteers, special populations, and patients.

    We are currently seeking a Bioanalytical Production Manager to join our dynamic lab operations team.

    • The Production Manager is responsible for overseeing assigned bioanalytical projects, which include nonclinical and clinical trials, bioanalytical method development, method validation, and study sample analysis at Pharma Medica Research Inc.
    • Manage the technical staff in the laboratory and review analytical data to ensure accuracy, compliance with GLP, SOP, and regulatory standards. The role reports to the Lab Manager, Production/R&D, or designate.
    • Track all ongoing bioanalytical method development, validation, and sample analysis for non-clinical and clinical trials.
    • Under the guidance of Lab Management, allocate appropriate timeframes for project completion and ensure adherence to deadlines.
    • Prior to receiving study samples, ensure all involved laboratory personnel are trained on the analytical method.
    • Order necessary supplies for the study, prepare pools, and randomization charts before commencing the analysis.
    • Prepare BVP / BSAP and set up the project in LDMS before initiation.
    • Ensure that the laboratory staff comply with regulatory guidelines, GLP procedures, Laboratory and PMRI SOPs, clinical study protocols, and BVP / BSAP.
    • Verify all raw data from bioanalytical studies and report any issues to the Principal Bioanalytical Investigator/designate.
    • Address audit findings for completed validations and studies to maintain study completion timelines.
    • Suggest improvements in laboratory organization, operations, project management, and SOP implementation.
    • Keep Laboratory Management updated on raw data, instrumentation, and calibration status within the laboratory.

    This role requires a Community College Diploma in Chemical Technology or a related scientific field.

    Knowledge of spreadsheets and word processing software is beneficial.

    The ideal candidate should possess leadership qualities to develop a team capable of delivering high-quality bioanalytical measurements efficiently.

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