WuXi AppTec

  • Senior Laboratory Technician - Molecular Biology, 2nd Shift

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4358
  • Overview

    Independent associate responsible for performing assays and related activities to support testing of manufacturer products, as well as standard and custom testing, following cGMP Guidelines.

    Responsibilities

    • Performs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines, and SOPs using appropriate laboratory techniques for the lab group assigned to.
    • Performs laboratory support functions (e.g. materials stocking function) to help ensure lab is operational and contributes to the overall operations and to the achievement of departmental goals and objectives.
    • Adheres to and understands the importance of Good Manufacturing Practices, Good Laboratory Practices, and standard operating procedures, including Good Documentation Practices. Has a working knowledge of the regulatory compliance requirements for the testing of biologics.
    • Performs all Standard Operating Procedures (SOP’s) and revisions, and Reagent Preparation Records as needed to accurately reflect testing procedures.
    • Reviews data entries in lab notebooks, instrument logbooks, and lab cleaning forms to comply with regulatory requirements.
    • Creates testing documents and performs revisions to existing documents (e.g., BRs, RPs, SOPs) following the DCR process.
    • Attend Huddle 1 on a regular basis and escalate issues/concerns at that forum to the supervisor for further investigation.
    • Initiating and assisting the completion of NCEs and LIRs within the Master Control environment with minimal assistance of a technical reviewer or supervisor.
    • Maintains a working knowledge of the primers/probes/standards/reagents used for testing and preparing them when needed.
    • Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance. Demonstrates innovative technical knowledge and significantly contributes to the overall production efficiency.
    • Supports technical transfer of assays from client to Technical Development to Operations; supports additional research level testing activities. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
    • Works on routine assignments per written procedures, as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations.  Works with minimal supervision from supervisor or Technical Reviewer.
    • Completes all requisite site-specific and job-specific training (e.g, Bloodborne Pathogens, Safety, GDP, Radiation Safety).
    • Contributes to the achievement of company and departmental goals and objectives.
    • Analyzes scientific data with accuracy and precision, critical at time of processing. 
    • Ensures junior manufacturing personnel comply with Standard Operating Procedures (SOP’s) and Batch Records and that training records for junior staff are accurate and current.
    • Possesses sound scientific knowledge and understanding of molecular testing assays and uses this skill set to routinely monitor testing processes and recognize potential process issues as they arise.
    • Authors and reviews non-compliance reports, laboratory investigation reports, SOP revisions, and Batch Record revisions to ensure documents are accurate and complete.
    • Provides training and operational guidance to junior staff and also serves to mentor junior staff in manufacturing techniques.
    • Functions as area operational leader providing both technical leadership as well as leadership to staff in area with respect to work assignments and schedules.
    • Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
    • Works with senior personnel to improve and optimize molecular methods.
    • Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary.  
    • Expert on all aspects of assigned processes.
    • May provide feedback to area management on junior staff performance.
    • Provides technical expertise to area associates and supervision during process and equipment troubleshooting exercises.
    • Normally receives little to no instructions on routine work and minimal instructions on new assignments.
    • Works under supervision from supervisor or senior personnel.
    • Ability to work in a team environment and independently as required
    • Maybe required to work overtime 
    • 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.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
    • Other duties as assigned
    • May be required to assist in other departments

    Qualifications

    Experience / Education   

    • A minimum of 4 or more years of relevant experience or equivalent
    • Bachelor’s degree with major in Biology, Chemistry or related Science major. Relevant prior work experience with nucleic acid techniques including end-point PCR, quantitative PCR, and gel electrophoresis required.
    • Experience in PCR primer design, hybridization and blotting techniques, and data analysis a plus.
    •  

    Knowledge / Skills / Abilities:

    • Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP facility is required.
    • Ability to work under limited supervision and to handle problems of a more difficult nature.
    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    • Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
    • Must be able to wear appropriate laboratory attire and all Personal Protective Equipment (i.e. labcoat, gloves, safety glasses).
    • Works in laboratory environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, sharps, solvents, pathogens), freezer burns, allergens and strong odors. 
    • Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program
    • Technician required to work assigned schedule.
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English.
    • Proficient in Microsoft (Excel, Word, Outlook)
    • No travel is required

    We are an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled.

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