WuXi AppTec

  • Associate Scientist – Genetic Stabililty

    Job Locations US-PA-Philadelphia
    Job ID
    2019-5646
  • Overview

    Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab.  Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.  Demonstrates supervisory skills and contributes to the achievement of company and departmental goals and objectives.  Performs and directs Genetic Stability assays, especially Southern Blotting, according to and in compliance with current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).

    Responsibilities

    • Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
    • Accurately completes batch records and other required documentation according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
    • Demonstrates innovative and independent scientific technical expertise.
    • Works with Lab Supervisor in scheduling and coordinating day-to-day laboratory operations.
    • Contributes independently to overall scientific rigor through objective laboratory investigation.
    • As assigned by Management, supervises personnel and assumes all associated responsibilities.
    • As assigned by Management, acts as Technical Reviewer, Area Manager, or Principal Investigator for assays and assumes all associated responsibilities. 
    • Demonstrates proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
    • Designs and independently conducts scientific development projects from inception to completion.
    • Conducts critical review of results and reports data to Technical Reviewer, Area Manager or Principal Investigator.
    • Initiates, prepares and revises technical documents and reports.
    • Effectively communicates and defends science through written and verbal communication.
    • Maintains laboratory notebook and follows all general and laboratory SOPs.
    • Performs assays using appropriate laboratory techniques for lab group assigned to.
    • Reports observations of ongoing tests to Technical Reviewer, Area Manager or Principal Investigator.
    • Communicates with supervisor and other colleagues re: daily lab activities.
    • Reviews and signs lab notebooks.­­­­
    • Provides training on areas of technical expertise and compliance issues relevant to the lab setting and trains new personnel in lab procedures.
    • Effectively interacts with clients as required.
    • Documents test article information on temperature charts for monitored equipment and gives copy to Quality Assurance as needed.
    • Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.

    Qualifications

    Experience / Education   

    • Master’s degree with a major in Biological Sciences or science related major or equivalent training and/or experience; or a minimum of 7 years of relevant experience or equivalent with a Bachelor’s degree with commensurate experience.

     

    Knowledge / Skills / Abilities:

    • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.
    • Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required.
    • Knowledge of EU cGMPs highly desirable.
    • Ability to write and revise documents. Ability to use judgment in situations for which there are no precedents.
    • Experience in GLP and GMP.
    • Ability to work under limited supervision and to handle problems of a difficult nature.
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)  

    Physical Requirements:

    • Must be able to work in Lab setting with Biohazards /various Chemicals
    • Must be able to wear appropriate PPE.
    • Must be able to work in environment with variable noise levels.
    • Ability to stand or sit for long periods of time.
    • Ability to perform light physical work, lifting up to 20 pounds as needed.
    • Ability to crouch, bend, twist, and reach.
    • Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors.
    • Must be able to perform activities with repetitive motions.
    • Inside working conditions.

    Our Values:

     

    Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

     

    Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

     

    WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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