WuXi AppTec

Principal Scientist – Customer Testing and Regulatory Support

US-PA-Philadelphia
Job ID
2017-2953

Overview

The Technical Specialist will be responsible for providing expertise, consultation and technical guidance for Philadelphia Biological testing services.  The Technical specialist will work closely with Clients, Sales, Project Management and Operations to provide guidance with respect to testing programs based on the Product Type, Phase in clinical development and regulatory requirements.  They will recommend appropriate assays and sample requirements per WuXi AppTec’s Testing Platforms, assist with development of testing quotes, and field technical questions from external and internal clients. 

Responsibilities

  • Provide expertise, consultation, project planning and project support for internal and external clients.
  • Assist in writing, implementation, and maintenance of technical and business development documents
  • May perform technical review and approval of technical documents.
  • Provides technical support during client visits or conference calls related to Philadelphia testing services
  • Provide Technical Presentations to external and internal clients
  • Interacts with clients to discuss project planning & testing questions prior to project initiation or to assist with trouble shooting.
  • Interacts with internal staff to identify area requiring further improvement or development and oversees the implementation of these improvements.
  • Support Business Development through webinars, business review meetings, face-to-face presentations, training, etc.
  • Author technical literature specific to the WuXi AppTec

Qualifications

  • Experience with supporting biosafety testing programs and / or Gene Therapy programs.
  • Understanding of the Guidance Documents supporting Biosafety Testing (ICHQ5A, Points to Consider).
  • Demonstrates a clear understanding of the contract laboratory testing business
  • Client Management Experience - Ability to receive, comprehend and effectively communicate detailed information through verbal and written communication.
  • Ability to evaluate technical data and write technical documents.
  • Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required. 
  • Has a strong working knowledge of the regulatory compliance.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Perform primarily sedentary work.
  • Bachelor’s degree with major in Biological Sciences or other science-related major
  • 5+ years experience required.

Equal Opportunity Employer/Veterans/Disabled

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