WuXi AppTec

Raw Material Specialist

Job Locations US-PA-Philadelphia
Job ID
2021-8911

Overview

Maintains current knowledge of regulatory guidelines and requirements related to control and testing of raw materials for advanced therapy manufacturing and provides guidance to Manufacturing and Process Development Departments and core teams.  Performs material verification and suitability review to support creation of program-specific control strategies.  Participates in client calls and face-to-face meetings with limited assistance by departmental senior staff.  Supports material-related investigations and assessments. 

Responsibilities

  • Maintains current knowledge of regulatory guidelines and requirements related to control of raw materials, consumables and drug product containers and closures
  • Authors and/or revises technical assessments, as needed
  • Partners with Material Review Board (MRB) lead to perform suitability review of raw materials, consumables and drug product containers and closures, and determine phase-appropriate testing requirements
  • Provide technical support and guidance to Manufacturing and Process Development core teams, as needed
  • Contributes to material-related investigations supporting Corrective and Preventive Actions resulting from Non-Conforming Events, Deviations and Laboratory Investigations as needed
  • Creates and maintains end-user resources and tools supporting adherence to internal policies and procedures
  • Authors and/or revises controlled documents as needed
  • Supports delivery of client-specific control strategy and summary documents through gathering and/or reviewing Quality documents, and interfacing with Manufacturing and/or Process Development to ensure completeness and accuracy of information
  • May be required to assist in other departments
  • May be required to work nights and weekends

Qualifications

Experience / Education   

  • Bachelors’ degree in Biological Sciences or science related field with 6 years of experience or
  • Master’s degree in Biological Sciences with 4 years of experience or
  • PhD in Biological Sciences with ≥ 1 year of experience

 

Knowledge / Skills / Abilities:

  • Experience in a cGMP environment is required
  • Experience in cell-based manufacturing, Quality Assurance or Regulatory Support required
  • Experience in analytical development and/or raw material characterization a plus
  • Experience with gene therapy vectors and/or gene mediated cell therapy highly desirable
  • Excellent Oral & Written communication skills required
  • Proficiency in Microsoft (Excel, Word, Outlook) required
  • Ability to work under limited supervision and to handle problems of a complex nature required
  • Proven troubleshooting skills highly desirable
  • Ability to use judgment as dictated by complexity of situation
  • Familiarity in Materials Science a plus
  • Project management experience is a plus

 

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

 

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

 

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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