• Senior Engineer, Manufacturing Science and Technology (IL or NC) - Fill Finish ( Multiple Openings)

    Job Locations US-IL-Libertyville
    Posted Date 2 weeks ago(12/3/2018 2:21 PM)
    Job ID
    2018-2774
    # of Openings
    1
    Category
    Engineering/Validations/BioProcess
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company, 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.

     

    The Senior Engineer is responsible for leading process development and improvement activities for the Drug Product/Fill-Finish manufacturing processes used to manufacture AveXis gene therapy products. This individual will define and direct the activity with internal and external organizations to plan, execute, and document early manufacturing that define the product and process of new AveXis gene therapy candidates. This individual will be responsible for the collection and interpretation of data and collaboration with other departments on manufacturing and product compatibility related issues to drive resolution and process improvements. The Senior Engineer will perform development experiments and oversee the data and reports to support regulatory applications.

    Responsibilities

    • Serve as a key scientific and technical lead for Drug Product/Fill-Finish processes at internal and external manufacturing facilities.
    • Partner with Manufacturing and Quality to meet the production schedule, ensure clinical/commercial supply and uphold quality standards.
    • Provide technical/scientific support in process development and qualification efforts for clinical and commercial launch, i.e. material compatibility studies, product stability, process and shipping qualification.
    • Support regulatory applications as subject matter expert for Drug Product/Fill-Finish operations and process development experiments.
    • Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
    • Seek operational excellence and continuous improvement opportunities and implement potential process improvements in conjunction with operations.
    • Support tech transfer and start-up efforts of new products and equipment into GMP manufacturing.
    • Assist in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
    • Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.

    Qualifications

    • PhD in biochemistry, chemical engineering, bioengineering, or related technical field or Master’s degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 3 years of experience in support of biopharmaceutical manufacturing or Bachelor’s degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 5 years of experience in support of biopharmaceutical manufacturing
    • Excellent oral and written communication skills.
    • 5-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in sterile filtration and aseptic fill-finish.
    • Familiar with global regulations on devices, drugs, validation/qualification requirements.
    • Strong technical writing ability.
    • Proven ability to effectively lead and participate on teams.

     

    Up to 50% travel may be 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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed