WuXi AppTec

  • Principal Scientist – CMC Lead

    Job Locations US-PA-Philadelphia
    Job ID
    2019-5819
  • Overview

    This is a program leadership position within Process and Technical Development department that has responsibility to lead early and late stage cell and gene therapy programs.

    Responsibilities

    • Lead cell therapy and gene therapy development programs with responsibility for development strategy, technical completeness and commercial readiness
    • Work closely with process development functional groups, analytical development group, supply chain, manufacturing, QA, facility, and partner with client delivery (project management) and business development, to meet the project objectives for our clients.
    • Lead the matrix development team and work closely with clients to develop product specific phase appropriate CMC strategies, support regulatory filing with CMC information.
    • Interface effectively with clients and internal stakeholders across the organization to accelerate development.
    • Facilitate technology transfer from client to internal stakeholders and from PD to manufacturing
    • Communicate effectively to internal stakeholders, facilitate solution development and keep the project on track.
    • Communicate effectively to clients on technical strategies, progress and outcomes, in partnership with client delivery.
    • Stay current with regulatory guidance on cell and gene therapies
    • Stay current with technologies and participate in scientific conferences, represent WuXi to potential clients where appropriate.
    • Partner with China team as needed.
    • Be able to connect with all levels within the organization

    Qualifications

    Experience / Education   

    • 10 years of relevant Bio pharm / Biotech industry process development experience in cell therapy, viral vector, vaccine or biologics.
    • M.S.or Ph.D. in (Bio) Chemical Engineering, Biology, Molecular Biology, Biochemistry, Virology, or relevant disciplines. 

    Knowledge / Skills / Abilities:

    • Matrix leadership experience is a plus
    • Experience in process development for biological products, cell and gene therapies preferred
    • Experience in early and late stage development, and phase appropriate strategies.
    • Understanding of regulatory guidance in CGT field and relevant experience is a plus
    • Strong verbal and written communication skills and effective interpersonal skills
    • Demonstrated ability for critical thinking and innovation
    • Able to understand and communicate risks, and develop and execute contingency plans
    • Works in laboratory and production environments with potential exposure to occupational hazards including chemical cleaners, biohazardous materials, noise, mechanical and heat/cold energy. Must be able to wear all required Personal Protective Equipment (PPE).  Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.

     

    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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