WuXi AppTec

  • Senior Director, Manufacturing

    Job Locations US-PA-Philadelphia
    Job ID
    2019-6026
  • Overview

    Oversees and is responsible for the Cell & Gene Therapy Manufacturing group for both Clinical and Commercial processing in the state of the art Cell Banking and Advanced Therapy facilities (3). Works closely with support function leaders and Area Management to ensure day-to-day MFG operations are performed within WuXi Quality standards. Maintains rigorous quality and HSE mindset and advocates strict adherence to compliance practices within the department and the facility. Possesses rigorous scientific skills with regards to cell and gene therapies and a strong working knowledge of the current Good Manufacturing Practice (cGMP) compliance requirements for manufacture of biologics and/or C&GT.

    Responsibilities

    • Prepares / approves process specific protocols, Policies, and Standard Operating Procedures (SOPs)
    • Ensures MFG schedule is maintained assuring customer timelines remain intact
    • Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards
    • Evaluates / Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems
    • Conducts employee performance appraisals in a timely and objective manner
    • Interacts with clients to discuss project planning and requirements
    • Reviews and recommends execution content for proposals for MFG programs
    • Design production schemes and process improvements
    • Interpretation of MFG PD and /or verification run results
    • Provides strong in-house guidance on science and technology
    • Interacts with internal staff to identify areas for improvement or development and oversees improvement efforts delivering performance efficiencies to impact departmental gross margin
    • Travels with other WuXi AppTec staff to visit clients / vendors as appropriate.
    • Presents technical seminars at external professional meetings.
    • Prepares and report key performance measures weekly, Quarterly and Annually
    • Drives startup operations for new facilities through technical and organizational leadership from the Manufacturing lens to keep the project on schedule and within budget
    • Drive financial performance of department through industrial efficiency, human capital management and greater utilization of physical assets
    • Specifying equipment, identification and development of Standard Operating Procedures (SOPs) and Master Batch Records
    • Commissioning and validation as well as staffing and training of the Manufacturing group to be competent in current Good Manufacturing Practices (cGMP)
    • Interacts with Engineering, Maintenance, Validation, Quality Assurance, Quality Control, Materials Management groups, and material/equipment vendors and commercial partners

    Qualifications

    Experience / Education

    • 10 or more years of relevant experience or equivalent
    • Bachelors’ degree in Biology, Chemistry or other Science related field or equivalent experience
    • Minimum of 8 years supervisory experience is required
    • Knowledge of cGMP guidelines is required.
    • Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
    • Ability to evaluate technical data and write technical documents.
    • Ability to use judgment as dictated by complexity of situation.
    • Ability to work under limited supervision and to handle problems of a difficult nature.

     

    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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