• Director, Manufacturing Operations

    Job Locations US-IL-Libertyville
    Posted Date 3 weeks ago(7/24/2018 10:45 AM)
    Job ID
    2018-1246
    # of Openings
    1
    Category
    Manufacturing
  • 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.

     

    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, 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.

     

    The Director of Manufacturing Operations is responsible for building, organizing, sustaining and continuously improving the manufacturing operations organization at the plant/site by working cross functionally to establish operational strategies and plans aligned with the overall site strategy.

     

    Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products, promote a culture of quality and compliance all while driving a sense of continuous improvement and operational excellence mindsetEnsure all processes, procedures, etc. related to operations are in full accordance with good manufacturing practices, code of federal regulations, site quality systems and company policies.

    Responsibilities

    • Develop and deliver a robust overall operations strategy and ultimate plan that meets the site's strategic objectives and results in a fully compliant facility, procedures and processes
    • Support the product requirements to ensure that all products are produced according to plan and do not go into backorder
    • Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools
    • Participate in all FDA and internal audits of the manufacturing facilities and processes and respond to any observations received
    • Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies
    • Participate in new product implementation product transition processes to ensure smooth transit ion from process development into GMP manufacturing
    • Partner with supply chain in driving monthly and annual production planning process and appropriately mange inventory levels - including critical raw materials, work-in-progress and drug product - to ensure clinical and commercial supply plans are met
    • Provide direct technical and managerial leadership to the operations and process development groups
    • Drive operational excellence and continuous improvement
    • Responsible for all production related expenses
    • Partner with Quality to ensure a quality and compliant manufacturing environment
    • Drive investigations through partnerships with Quality and other business units at the site to determine root cause, implement a solution and follow up with a verification check to ensure the fix was effective.
    • Represent manufacturing on the monthly Quality Management Review meetings
    • Partner with the technical operations team to resolve any issues related to production
    • Participate in the interpretation of data and collaboration with other departments on all manufacturing related issues to drive resolution. Assist with process development activities and production of drug products for clinical trial studies.
    • Ensuring organizational effectiveness by providing leadership and guidance for his/her team.
    • Hire and train key manufacturing personnel for both upstream cell culture and downstream purification and filling operations, including aseptic production.

    Qualifications

    • Minimum B.S. degree in biochemistry, bioengineering, or related technical field
    • A minimum of 8-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with:
    • Proven track record organizing and operating a gene therapy manufacturing facility
    • Manufacturing for orphan disease indications is a plus
    • 5+ years of direct supervisory experience of technical professionals and managerial level staff with demonstrated effectiveness in providing guidance, mentorship and support to staff
    • 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
    • Ability to motivate staff, foster a culture of continuous improvement and operation excellence
    • Understanding of new manufacturing technologies including single use disposable manufacturing within modular facilities
    • Experience with 3rd parties {both in-sourcing and outsourcing)
    • Strong project management skill set with extensive experience in strategic I tactical planning, demonstrated ability to perform long-term project planning, team building and budgeting
    • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere
    • Troubleshoot all manufacturing issues while driving towards issue resolution
    • Approximately 20% travel required

     

    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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