WuXi AppTec

  • Trainer - Manufacturing/Testing

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4363
  • Overview

    Responsible for training those who produce Master and Working Cell Banks and activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). In addition may also be responsible for training testing staff in basic laboratory operations

    Responsibilities

    • Conducts mock or simulation sessions as means for delivering training
    • Trains staff on aseptic technique, cell culture and pipetting techniques
    • Trains staff on good documentation practices for batch records, logbooks and other required documentation
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
    • Trains, coaches and mentors others on basic aseptic operational techniques such as gowning, media preparation, thaw, passage and harvesting and overall systems and operations
    • Is able to identify unacceptable practices and make spot corrections to performance
    • Understands and trains others on basic operations and functions of equipment and is able to perform basic troubleshooting
    • Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry, ideally in cell and gene therapy
    • Creates, revises, reviews and finalizes material documents
    • Uses and trains others on the use of support systems (e.g. LIMS) with some proficiency
    • Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
    • Follows, executes and trains other to follow and execute analytical methods, Standard Operating Procedures (SOPs) and Batch Records (BRs)
    • Performs, trains, coaches and mentors others to maintain record filed and databases
    • Possess basic computer skills and able to efficiently use basic Microsoft applications
    • Suggests, participates, implements and leads continuous improvement ideas
    • Responsible for ensuring associates are trained and able to perform operations
    • Performs well under minimal supervision and works independently on training tasks and processes
    • Ideally has curriculum design experience
    • Ideally possesses learning and/or training accreditations and certifications
    • May be required to work Holidays and weekends
    • May be required to work Overtime
    • May be required to work outside of normal business hours
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Other duties as assigned
    • May be required to assist in other departments

    Qualifications

    Experience / Education   

    • High School diploma and over 6 years of relevant experience or
    • Associates’/Bachelor’s (science preferred) degree with over 3 years of relevant or equivalent experience

     

    Knowledge / Skills / Abilities:

    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    • Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program. 
    • Holiday and shift work often required based on manufacturing schedule as determined by Management.
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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