WuXi AppTec

  • Chemistry Manufacturing Controls Project Director

    Job Locations US
    Job ID
    2018-3965
  • Overview

    WuXi Biologics, a Hong Kong-listed company, is a leading global biologics services provider that offers comprehensive, integrated and highly customizable services. The company offers multinational pharmaceutical and biotechnological companies in the world end-to-end solutions and is seeking a Chemistry Manufacturing Controls Project Director to lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team.  The incumbent will also participate in business development activities such as visiting existing or new clients and promoting Biologics’ services in conferences/trade shows.

    Responsibilities

    • Provide project and portfolio leadership supporting IND enabling and late stage product development CMC activities.
    • Collaborate with CMC functional areas to ensure successful execution of various CMC projects, and delivery of results on time and within budget.
    • Assists with development and manufacturing alliance management, product development and manufacturing strategy.
    • Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients.
    • Work with a high performance team to ensure best quality services
    • Enhance current service offering and develop new clients.

    Qualifications

    Experience / Education

     

    • Ph.D. in Bio/Chemistry, Bio/Chemical Engineering or related discipline, MBA.
    • Technical experience in large pharma or biotech companies
    • Biologics development and manufacturing experience.

    Knowledge / Skills / Abilities:

    • Proficient in Microsoft Office (Project, Excel, Word and Outlook).
    • Travel is required ~25%- Domestic and International, Daily/Overnight.
    • Candidate should possess strong and effective project management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.
    • Demonstrates good understanding of the pharmaceutical industry and biologics drug development.
    • Minimum of 10 years of relevant pharmaceutical or biotech industry experience in biologics CMC development and/or GMP manufacturing.
    • Working knowledge and understanding of current regulations and industry trends for biologics and Antibody-Drug Conjugate (ADC) product development, manufacture and testing.
    • Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required. 

    Independence/Accountability:

    Must be a self-starter, self-motivated, and highly flexible in this homebased position with ~25% travel.

    Must be organized and detailed-oriented.

     

    Problem Solving:

    Proven experience in creating and carrying out successful plans and processes to solve complex problems.

     

    Leadership Activities:

    Work closely with team members across all CMC related business units to ensure coordination of all efforts and real-time communication with all stakeholders. 

    Communication Skills:

    Fluent in both English and Mandarin is required.

    Excellent communications skills (verbal, written, and presentation skills). 

     

    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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