WuXi AppTec

  • Senior Laboratory Technician - Remote Viral Clearance

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4307
  • Overview

    Technician in Remote Viral Clearance and AKTA Maintenance, who works under the guidance of a Supervisor/Manager. Performs studies and equipment change over according to, and in compliance with, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Serves as a point person to help organize work flow, resources, and day to day lab responsibilities. Sufficiently competent in science to serve as a Qualified Trainer as needed.

    Responsibilities

    Conduct viral clearance studies and lab procedures as outlined in testing record and regulatory guidelines.
    • Accurately complete testing records and other required documentation according to WuXi’s Good Documentation Practices
    • Basic maintenance and inter-study changeover of AKTA Explorer, Avant 150 and Avant 25 FPLC systems.
    • Lead the execution of nanofiltration and column chromatography steps in the performance of viral clearance studies.
    • Report observations of ongoing studies to Study Director or Manager.
    • Coordinates with Remote Viral Clearance Manager and other colleagues to ensure sufficient resources are allocated to complete tasks in a timely manner.
    • Preparation of reagents needed to carry out AKTA maintenance and other associated duties.
    • Maintenance of equipment and cleaning logs. Initiation of Change Controls when appropriate.
    • Aid in the training of new employees as a qualified trainer.
    • Initiate and write nonconformance reports and laboratory investigations as required.
    • Verify that all executed Test Methods are accurate and complete prior to submission for review.
    • May be called upon to write Testing Methods and Standard Operating Procedures.
    • Take a leading role and participate in internal and external R&D projects and collaborations/ validations relevant to the Remote Viral Clearance Group
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.

    May be required to work overtime, holidays, and weekends as required.
    • Contributes to the overall operations and to the achievement of departmental goals
    • Thorough understanding of Good Laboratory Practices and Good Documentation Practices
    • Performance of other duties as assigned and may be required to assist other departments as needed.

    Qualifications

    Experience / Education:
    • At least 3 years of relevant experience or equivalent
    • Bachelors’ degree in Biological Sciences or science related field or equivalent experience
    • Previous Laboratory experience with a strong emphasis on column chromatography and nanofiltration.
    • AKTA FPLC and Unicorn Software experience is a must.


    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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