WuXi AppTec

  • Associate Director/Director, Downstream Development

    Job Locations CN
    Job ID
    2018-4114
  • Overview

    Downstream Process Development Wuxi subdivision is responsible for purification process development, scale-up, technical transfer, process characterization, and support for pre-clinical, clinical, commercial manufacturing, and regulatory filing.

    Responsibilities

    • Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing and commercial production.
    • Lead a purification process development project
    • Effectively and timely communicate with clients, maintain and build up good relationship with clients, and being responsible for company images and reputation
    • Actively cooperate with other department colleagues to fulfill assigned tasks and in line with department decision
    • Prepare dossiers and data packages to assist with the interactions with Regulatory agencies.
    • Assist his/her manager and functional head to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
    • Coach and lead his/her team staff on process development.
    • Manage his/her team effectively in a fast paced environment.
    • Follow company code of conduct and compliancy
    • Follow and improve laboratory regulation

    Qualifications

    • MS with 10+ years, or PhD with 6+ years downstream process development experience.
    • At least 4 years’ people management experience
    • Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
    • Experience in downstream process cGMP production.
    • Experience in downstream process validation
    • Experience in working with the cross-functional teams.
    • Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
    • Experience in regulatory submission to FDA/EMA.

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled  

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