• Director, Process Automation

    Job Locations US-NC-Raleigh
    Posted Date 1 month ago(4/24/2018 10:59 AM)
    Job ID
    2018-1190
    # 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.

     

    Position Summary

    AveXis, Inc. is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

    Director, Process Automation will ensure availability, functionality & reliability of manufacturing automation system and associated IT infrastructure to enable current and future production flow in a safe, quality and cost-effective manner.

    Responsibilities

    • Maintain process automation system and network infrastructure multi-site manufacturing organization in an effective operating and compliant state.
    • Ensure that installations and changes to process automation systems and GMP network infrastructure are qualified according to approved protocols, change control procedures and in compliance with relevant cGMP and corporate requirements.
    • Develop a multi-year plan that provides a roadmap for required automation system and GMP network infrastructure upgrades and investments, Including data management and data integrity measure to ensure business continuity aligns with the global manufacturing strategy.
    • Initiate and lead introduction of new assets, and systems that will contribute to the business strategic direction, in accordance with approved change control procedures.
    • Provide necessary guidance to ensure compliance with all applicable external and internal regulations and requirements regarding Quality and EHS in the scope of Process Automation Systems.
    • Drive Continuous Improvement to meet world class manufacturing standards using Operational Excellence principles while continuously developing Automation and Infrastructure best practices.
    • Manage an efficient and effective Automation program through managing the Engineering site budget and resources.
    • Identify, develop and retain qualified people to provide Process Automation and GMP Network services for multiple sites in the Manufacturing organization.
    • An influential functional expert within the site leadership team. Influence decision making and take an active role in promoting cross-site initiatives, team work and collaboration across site’s functions.
    • Implement global best practices and actively share knowledge and lessons learned to contribute and support a high professional level of Process Automation
    • Serve as the main representative in communication with suppliers, subcontractors and planning firms regarding the site’s automation systems and GMP Network Infrastructure. Supervise their activity to ensure efficient and effective work and to ensure our business interests and global agreements and standards are well kept.

    Qualifications

    • BS in Electrical, Chemical, or Computer Engineering required.
    • Relevant Master's Degree preferred.
    • 8+ years in a biotechnology, gene therapy or pharmaceutical industry supporting batch and continuous control systems required.
    • 8+ years in project management required.
    • Proven ability to manage teams across multiple sites.
    • Experience in manufacturing facility start up preferred.
    • Proven knowledge and experience with risk based approach to compliant validation and change management for GMP computerized systems.
    • Working knowledge of GEP (Good Engineering Practices).
    • Proven knowledge of both clinical and commercial manufacturing.
    • Ability to align site network and automation capabilities with company objectives.
    • Proven ability to manage Capital and Operational expenses required.
    • Knowledge of the current pharmaceutical, regulatory and technology trends preferred.

     **This position will cover multiple sites. 

     

    The level of this position will be based on the final candidate’s qualifications.

     

    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.

     

    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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