WuXi AppTec

  • CMC Project Manager

    Job Locations US
    Job ID
    2018-4480
  • Overview

    The CMC Project Manager will be responsible for managing projects within STA, WuXi’s API and Drug Product development and manufacturing division.  Leads 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 STA’s services in conferences/trade shows. 

    Responsibilities

    • Lead all project initiation and planning efforts. Participate in the implementation and execution of a given project.
    • Establishes project objectives, timelines and deliverables. Defines project tasks and resource requirements. 
    • Closely monitor/control project progression to ensure project is completed on schedule and within budget. Reports project progress to all key stakeholders. 
    • Supports the technical team to investigate any project challenges by necessary risk assessment tools & techniques, then implements corrective measures.
    • Serves as liaison with client contacts, manages day-to-day communications and organizes project team meetings.
    • Represents company in project meetings, prepares meeting agenda and minutes, and follows up on action items.
    • Evaluates and assesses project results and provides recommendations for future improvements.
    • Provides support to the business development team joining customer visits, conferences or tradeshows.
    • Prepare Quotations/Proposals/Change Orders with inputs from key stakeholders for existing relationships

    Qualifications

    Technical Skills / Knowledge:

    • 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 small molecule drug development.\Minimum of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing.
      Working knowledge and understanding of current regulations and industry trends for small molecule 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. 
    • Must have working knowledge of MS Office products, especially MS Project.

    • 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 and with the STA management team to ensure coordination of all efforts and real-time communication with all stakeholders.  
    • Communication Skills:
    • Proficiency in both English and Mandarin is required.
    • Excellent communications skills (verbal, written, and presentation skills).  
    • Customary Education and Experience:
    • Masters (MS) or PhD in life sciences; chemistry preferred
    • A minimum of 5 years pharmaceutical or CRO/CMO industry experience preferably in API process R&D and manufacturing and/or Drug Product R&D and manufacturing. 
    • Prior experience in project management or managing external research collaborations, with PMP certification desired
    •  

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