WuXi AppTec

  • Study Director

    Job Locations US-MN-St. Paul
    Job ID
    2018-4373
  • Overview

    Responsible for all aspects of assigned studies performed within the Chemistry department at WuXi AppTec. The Study Director serves as the interface between the St. Paul facility, Subcontract Laboratories and the Sponsor in terms of study planning, organization, execution, data interpretation, and final report construction. With minimal assistance from senior employees, the Study Director will handle resource planning and sponsor communication to complete the assigned studies on time.

    Responsibilities

    • Serve as the central point of contact within WuXi AppTec for assigned studies. Manage multiple standard and custom studies simultaneously.
    • Assist Senior Study Directors with designing custom studies and quoting.
    • 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.
    • Write custom protocols with little assistance.
    • Coordinate and develop instruction for complex extractions with assistance.
    • Ensure assigned studies are completed on time.
    • Troubleshoot unforeseen issues that may occur and coordinate preemptive solutions.
    • Address client questions and concerns.
    • Review interpretation of data and ensure coherence of a clear, well-organized, scientifically sound report.
    • Interact with technical staff to ensure protocol compliance and study validity.
    • Understanding of Good Laboratory Practices and Good Manufacturing Practices.
    • Undersanding of applicable guidance (ISO, BPOG, Extractable/Leachable, etc.)
    • Identify potential process improvements and best practices.
    • Provide input for standard operating procedures and assist in document maintenance.
    • Ability to work in a team environment and independently as required.
    • Contribute 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.
    • Required to be available via cell phone or email after work hours, and on weekends.
    • Other duties as assigned.

    Qualifications

    Experience / Education

    • Minimum Bachelor’s Degree in Scientific Field (Chemistry Preferred)
    • Analytical laboratory experience required
    • 1-3 years of previous study director experience in a GLP/GMP regulated environment

     

    Knowledge / Skills / Abilities:

    • Understanding of common analytical techniques including GC-MS, LC-MS, and ICP.
    • Strong customer service and effective communication skills.
    • Able to multitask and maintain attention to detail in a fast-paced environment with some management oversight.
    • Organized project management skills.
    • Development of strategic problem solving and critical thinking.
    • Strong scientific aptitude.
    • Need to be able to clearly speak, read, write, and understand English.
    • Strong Technical writing skills utilizing appropriate scientific terminology.
    • Experienced with 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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