WuXi AppTec

  • Senior Laboratory Technician, Viral Clearance

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4030
  • Overview

    Performs Cell Culture, qPCR and Cell-Based assays (BSL2 and BSL2+) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Sufficiently competent in science and may serve as a Qualified Trainer as needed. May have client-facing interaction.

    Responsibilities

    • Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
    • Performs assays using appropriate laboratory techniques for lab group assigned to.
    • Reports observations of ongoing tests to Study Director or Laboratory Manager.
    • Communicates with supervisor and other colleagues re: daily lab activities.
    • Performs daily work activities with minimal supervision.
    • Performance of labs upkeep per GLP, cCMP, CFR and/or PTC guidelines and SOPs.
    • May author Test Methods, Client Protocols and Operating Procedures
    • Author adverse events and reviews batch records to ensure documents are accurate and complete
    • Evaluates operating procedures for accuracy and efficient operations and makes corrections as necessary
    • Understands the importance of the regulatory compliance requirements for the production of biologics.
    • Coordinates with supervisor to move resources, if necessary.
    • May serve as qualified trainer and / or training coordinator and may perform classroom trainings.
    • Effectively interacts with clients, management, external departments and auditors as required for onsite studies or on the client’s behalf.
    • Acts as mentor to Junior Technicians.
    • May perform statistical analysis of raw data
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
    • Ability to work in a team environment and independently as required
    • Maybe required to work Holidays and weekends
    • 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 3 years of relevant experience with a Bachelors’ degree or 1+ years of relevant experience with a Masters’ degree or equivalent
    • Bachelors’ degree in Biological Science or other related science field or equivalent experience


    Knowledge / Skills / Abilities:


    • Possesses thorough knowledge of functional equipment
    • Knowledge of GDP, GLP and cGMP preferred
    • Effective multi-tasking skills and time management required
    • Ability to evaluate technical data and record data accurately and legibly
    • Ability to understand and follow verbal and demonstrated instructions
    • Ability to clearly express and exchange ideas by means of verbal and written communication
    • Ability to work effectively as part of a team and exhibit effective interpersonal skills
    • Ability to work under limited supervision and to handle problems of a difficult nature
    • Proficient in Oral & Written communication skills
    • Proficient in Microsoft (Excel, Word, Outlook)

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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