• Manufacturing Quality Associate- Gene Therapy

    Job Locations US-IL-Libertyville
    Posted Date 4 weeks ago(10/20/2018 11:51 AM)
    Job ID
    2018-1184
    # of Openings
    1
    Category
    Quality
  • 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 candidate, AVXS-101, is our proprietary gene therapy product 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 successful candidate will be responsible for the Quality oversight of manufacturing operations on the floor and working in collaboration with AveXis staff.  Responsiblities include but are not limited to the following: review and approve written procedures, on the floor batch record documentation review, monitor and control the manufacturing environment, plant hygiene, process validation, people/process/waste flow patterns, aseptic certification, nonconformance review/disposition, and monitoring compliance with all requirements of good manufacturing practice.  The Manufacturing Quality Associate is responsible for supporting the design and implementation of robust Quality Systems for a new viral gene manufacturing site and quality on the manufacturing floor.

    The Manufacturing Quality Associate will be responsible for quality related business systems such as non-conformance/CAPA, by contributing and reviewing for approval and assisting with the implementation and supporting on-going continuous improvements. The Manufacturing Associate will use risk based decision to address any issues on the Manufacturing floor and will serve as the quality point of contact for the operations. Will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a good knowledge of and application of the CFR’s and cGMP’s .

    Responsibilities

     

    • Complete on the floor quality audits and sampling during the manufacturing processes; knowledge of AQLs and visual inspection preferred

    • Good understanding of batch record execution, GMP and GDP.  Knowledge of upstream and downstream processing necessary.

     

    • Work effectively with operators on the floor and make on the spot, risk based decisions; escalate issues to management as necessary

    • Assist in developing and delivering robust overall quality systems resulting ina fully compliant facility with respect to procedures and processes Contribute to the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics; reporting to management all necessary information from plant floor

    • Provide support on quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA’s) and critical processing parameters (CPP’s)

    • Support and review of SOPs/Document Management: documentation management and SOPs all instruction sets, specifications, batch records etc. and other Quality procedures directly related to operations and other cGMP activities o On the floor Batch record review.
    • Ability to review controlled documentation during processing for GMP and GDP
    • Non-conformance/CAPA Management support and initial review of Non-conformances and CAPAs
    • Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause; provide input on the creation and effectiveness of Corrective and Preventive Action plans and assist in determining a root cause o In process sampling/ AQL sampling
    • Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product

     

    Qualifications

    • Minimum B.S. degree in preferably microbiology, chemistry or biochemistry or 5 years applicable industry experience. • A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification and aseptic fill/finish o Experience with viral gene therapies and/or orphan disease indications is a plus • Knowledge of FDA regulations and experience in US and international regulatory agency inspections • Direct experience reviewing standard operating procedures and partnering with operations on product related investigations and Non-conformances • Excellent oral and written communication skills with strong technical writing experience required • Experience with internal audits responsibilities and activities may change at any time with or without notice.  Willing to work off-shift hours as directed.


    This position will be located out of our Chicago area office

     


    Limited Travel

    Other Duties:

    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. 

     

    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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