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Principal Scientist (Reprocessing SME)

Overview:

The Principal Scientist (Reprocessing SME) is responsible for providing technical leadership and innovation for the Medical Device Reprocessing Program at WuXi AppTec ATL.

Responsibilities:

  • Uses knowledge of industry standards including AAMI, ASTM and FDA Guidance to provide strategic direction for the Reprocessing Program.
  • Represents WuXi AppTec at industry conferences, trade shows and client meetings including AMDR.
  • Leads client sponsored research related to Reprocessing of single use medical devices.
  • Interacts with client to discuss project planning and testing requirements.
  • Interacts with internal staff and management to identify assays requiring further improvements or development and oversees improvement of these assays.
  • Facilitate communication between members of the study team and sponsor.
  • Develop and maintain protocol templates for routine Reprocessing methodologies.
  • Support Account Managers through attending conference calls and writing proposals.
  • Work with multiple internal and external laboratories to ensure accurate and on-time project completion.
  • Review final reports to ensure accuracy, consistency and professional appearance.
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • 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.

Qualifications:

  • Bachelor’s Degree in related discipline or equivalent required, M.S. or Ph.D preferred
  • Minimum 10 years of experience in Life Sciences and/or Biotech environment
  • Strong knowledge medical device Reprocessing for single use and reuse devices
  • Demonstrated knowledge and application of cGMPs/GLPs, AAMI, ASTM & FDA Guidance Documents
  • Experience managing complex projects and meeting aggressive timelines
  • Experience as a GLP Study Director a plus
  • Ability to perform independent research
  • Strong organizational skills with attention to detail
  • Ability to perform complex mathematic and statistical calculations and data analysis, and to work with Excel and other scientific data analysis tools to collect and analyze data.
  • 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 support sales/business development and marketing through client presentations, seminars, etc.
  • Ability to manage projects and timelines
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook, PowerPoint)
  • Travel is required 25%, Domestic/International, Daily/Overnight

Equal Opportunity Employer Minorities/Women/Veterans/Disabled