WuXi AppTec

Study Director

Job Locations US-MN-St. Paul
Job ID
2021-8818

Overview

Who is WuXi AppTec?

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. Our St. Paul, Minnesota site is a rapidly growing global leader in the medical device (ranging from simple tongue depressors and adhesive bandages to complex programmable pacemakers) and combination product testing industries, focusing on nonclinical testing that includes biocompatibility, safety toxicology, and analytical chemistry.  Our teams support some of the most innovative medical devices and combination products created by leading medical device manufacturers both locally and globally. Our Test Facility plays a vital role in understanding the unique interface between biomedical engineering and the biology of living things.    As an innovative-driven, customer-focused organization, WuXi AppTec’s open-access platform enables global collaboration from over 30 countries to improve the health and/or treatment of patients in need, and to realize WuXi AppTec’s vision that “every drug can be made and every disease can be treated.”  For more information please go to http://us.wuxiapptec.com/.

 

WuXi AppTec Offers:

Medical, Dental, and Eyecare Coverage - Health Savings Account + Employer Contribution - Flexible Spending Account - 401(k) Savings Plan + Employer Match - Employer Paid Basic Term Life and AD&D Coverage

Employer Paid Long Term Disability Insurance - Short Term Available with Employer Contribution

Generous Personal Time Off Plan (PTO) + 10 Holidays Per Year

 

Department Description: 

The Study Operations department is the center point of control for all studies conducted within the facility. Study operations in responsible for development and execution to the study protocol, client communication about individual study information and clarification, and reporting of final assay results. Clients may request an individual test for an individual medical device, but often requests a panel of tests to support FDA submission depending on medical device use. Tasks executed within the department can be placed into the following three categories in most cases.

  • Front end work tasks involving a study would be review of study information, initiation of the study, and client communication involving clarifications such as test article preparation instructions. Review of study information and request for clarification are completed at a panel level when available and appropriate.
  • On test work tasks involving a study would be providing instruction and support to laboratory staff as necessary, troubleshooting and client communication of unexpected or unusual observations, and leading or being involved in investigations observed during the study and study impact such as deviations or laboratory investigations.
  • Back end work tasks involving a study would be complete review of study data, determination of study validity and results, drafting and finalization final report, and engaging with Quality Assurance during report review process as required. 

The Study Director role is responsible for executing and coordinating all tasks listed above on individual studies and is the single point of control throughout the lifecycle of the study.

Job Summary:  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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