WuXi AppTec

  • Study Director

    Job Locations US-MN-St. Paul
    Job ID
    2018-4492
  • Overview

    Responsible for all aspects of assigned standard biocompatibility studies performed within the In Vitro Testing Services (IVTS) department at WuXi AppTec in compliance with GLP, ISO, FDA, and any other applicable guidelines.  Interface between the St. Paul facility and the customer for study planning, organization, final report generation, and customer communication.

    Responsibilities

    • Serve as the central point of control for assigned studies. Manage and control several biocompatibility projects simultaneously. Ensures assigned studies are completed on time.  Interact with technical staff to ensure protocol compliance and study validity.
    • Analyze and interpret data, determine results and conclusions of the study, and generate a clear, well-organized scientifically sound report.
    • Maintain protocols, worksheets, and standard operating procedures.
    • Troubleshoot unforeseen issues that may occur during study. Work with laboratory management to resolve as needed.
    • Serve as the primary contact for the customer, and keep the customer informed of any unforeseen events or issues. Provide a high level of customer service.
    • Develop expertise in applicable guidance interpretation.
    • Ability to work in a team environment and independently as required.
    • 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.
    • Required to be available via cell phone or email after work hours, and on weekends.
    • May be required to assist in other departments.
    • Other duties as assigned.

    Qualifications

    Experience / Education

    • Bachelor’s Degree Required
    • 1-2 years of scientific industry experience outside the classroom.  Experience in a GLP/GMP regulated environment preferred. 

     

    Knowledge / Skills / Abilities:

    • Demonstration of basic customer service and project management skills.
    • Able to multitask and maintain a high attention to detail in a fast-paced environment with some management oversight.
    • Adept at critical thinking, problem solving, teamwork, and managing changing priorities.
    • Need to be able to clearly speak, read, write and understand English
    • Technical writing skills utilizing appropriate scientific terminology.
    • Understanding of bacterial and mammalian cell culture preferred.
    • Proficient in Microsoft (Excel, Word, Outlook)

     

    Physical Requirements:

    • Must be able to wear appropriate PPE
    • Must be able to work in environment with minimal noise levels
    • Clarity of vision
    • Ability to identify and distinguish colors
    • Must be able to perform activities with repetitive motions
    • Inside working conditions

     

    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

     

    This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

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