• Sr. Project Manager

    Job Locations US-NC-Durham
    Posted Date 2 weeks ago(6/1/2018 8:16 AM)
    Job ID
    2018-1269
    # of Openings
    1
    Category
    Engineering/Validations/BioProcess
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases?  AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    This position is responsible for providing project management to the capital projects group in support of the capitol portfolio.  This individual shall have a strong understanding of GMP’s and experience providing project leadership and oversight in a highly regulated or pharmaceutical / biotech facility.

     

    Manages projects in an effective and efficient manner by ensuring delivery for assigned projects.  Manages changes such as project expansion, change of scope and schedule, or budget and reports them with impact analysis.  Serves as the primary client contact for assigned projects.

    Manages all contractors and internal staff on projects.  Prepares, reviews, and approves scopes or work and proposals.  Manages all associated client project deliverables in line with the defined responsibilities of each project team member.

    Responsibilities

    • Manages an appropriate number of active projects with regular monitoring and support from upper management, ensuring all assigned projects are delivered on time and within the budget.
    • Leads the team to resolve all project issues and resource constraints affecting the portfolio with assistance from upper management.
    • Manages planning and scheduling conflicts among the project team and with production.
    • Manages client expectations efficiently with minimal guidance. Maintains strong working relationships with all client representatives.
    • Develops project objectives working with user requirement and business plans
    • Prepares, owns, and maintains project budgets
    • Reports on project performance for site leadership
    • Communicates issues or risks in a timely and effective manner and develops mitigation plans to address/resolve them
    • Prepare contingency plans and logically work through complex issues
    • Prepare vendor scopes of work (SOW) and request for proposals (RFP)
    • Work with suppliers and vendors for projects to review and receive quotes
    • Ensures all project close-out activities are completed.
    • Identifies and reports on lessons learned after the project close-out
    • Drive operational excellence and continuous improvement

    Qualifications

    • Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience
    • A minimum of 6 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish
    • Experience in the development, automation, and manufacture of gene therapy products, biotech or pharmaceutical products, medical devices, instruments, or biotechnology
    • Experience in process layouts, production layouts and capital improvement projects
    • In-depth knowledge of FDA regulations and GMP systems
    • Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high quality processes and end products
    • Excellent oral and written communication skills. Strong technical writing ability required

     

    Approximately 10-20% travel required

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

     

    This position will be located out of our Durham, NC facility.

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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