Immunomedics, Inc.

  • Supervisor, Quality Control

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(10/29/2019 10:54 AM)
    Job ID
    2019-1560
    # of Openings
    1
    Category
    Quality
  • Overview

    The Quality Control Supervisor is responsible for cGMP QC release and stability testing of biopharmaceutical drug products, drug substances and process intermediates using chemical analysis, and radiolabeling of materials. Authors and reviews protocols and executes testing to support analytical chemical method validation and technical transfer of methods. Participates on cross-functional project teams as a subject matter expert.  Develops and trains staff.

    Responsibilities

    • Works in a cGMP QC laboratory setting, responsible for chemistry related assays on process intermediates, drug product, and drug substance. Ensures timely delivery of test results to meet deadlines for delivery of accurate, verified release and stability data. Coordinates with external vendors for sample testing as needed.
    • Performs radioactive isotope labeling on materials including drug product, bulk substance, and process intermediates.
    • Performs high-level testing and data reporting; leads Quality Control system activities such as stability, information management, method validation, method transfer, quality system monitoring, and creation of protocols and reports.
    • Creates protocols and reports for, and participates in, the validation and technical transfer of analytical methods.
    • Performs timely and accurate review of laboratory data, proactively identifies and reports trends or suspect results, and thoroughly investigates and documents laboratory events and investigations.
    • Provides subject matter expertise regarding the current methodology and analysis. Develops, maintains, and revises relevant QC SOPs; prepares and presents technical data to management.
    • Ensures that laboratory equipment is qualified. Schedules and/or performs preventative maintenance and/or calibration activities. Maintains and appropriately documents use of equipment within the QC laboratory. Coordinates with external vendors for instrument installation, calibration, and maintenance and ensures a state of inspection readiness.
    • Maintains and improves Quality Control GMP compliance and documentation; ensures integrity of QC data for support of regulatory submissions.
    • Identifies and leads continuous improvement initiatives through effective use of change management, actively seeks ways to improve compliance and efficiency in QC and other related areas, and gathers and reports metrics to management.
    • Performs investigations to determine root cause, identifies CAPA activities, and trains staff in investigation, root cause, and CAPA processes. Assists management in oversight of investigations and CAPA systems.
    • Maintains required training and training records; trains staff as assigned and develops training materials as needed. Participates in hiring decisions as assigned.

    Qualifications

    • Entry Level MS or PhD OR Bachelor’s degree and 5 years GMP lab experience
    • Demonstrated leadership Prior cGMP/GLP training and experience working in a cGMP/GLP environment required.
    • Must have the ability to function with limited supervision. Extensive knowledge of and proficiency with current LC methodology (SE-HPLC, IEC, RP-HPLC, affinity chromatography, spectrophotometry) and associated instrumentation.
    • Familiarity with stability testing of biopharmaceutical products, information management, investigations, method validation, method transfer, instrument qualification, corrective actions / preventive actions management, and creation of protocols and reports.
    • Effectively participates in validation and technical transfer of analytical methods in compliance with FDA and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports.
    • Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
    • Must be able to work in a cross-functional team environment and perform job responsibilities. 
    • Must have familiarity with FDA and ICH guidelines and be able to follow SOPs and cGMP guidelines. 
    • Must be proficient with laboratory software/data acquisition and reporting applications and MS Office applications. 

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