• Sr. Manager, QC Stability & Sample Management

    Job Locations US-IL-Libertyville
    Posted Date 3 months ago(3/6/2018 10:11 PM)
    Job ID
    # of Openings
  • 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 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 Sr. Manager, Stability and Sample Management serves as the owner for all work processes associated with the Product Stability and Sample Management Programs at AveXis Inc.. He/she oversees the Stability Study Design and ensures test scheduling is executed in-house or at 3rd party contract laboratories according the respective stability protocols. The QC Sr. Manager serves as the SME for sample control and stability studies during regulatory inspections and as the document owner for procedures in support of the Product Stability and Sample Management Programs. The QC Sr. Manager responsibilities include, but are not limited to project management, technical writing, training, metrics, investigations, and sample management.  


    A potential candidate will possess a strong understanding of Stability Testing requirements per ICH guidelines.  Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations, effective interactions/communication with Site management, personal development, and support of investigations.  The QC Sr. Manager will also support the Director for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.  The QC Sr. Manager should be able to work effectively within the group, within Quality, and across the site.


    • Serves as owner for work processes supporting the Stability and Sample Management programs
    • Develops the Stability Study Design and ensures scheduling of stability lots
    • Manages all stability studies through execution of the following:
      • Author protocols and reports
      • Data entry, review
      • Provides Quality Representation on Product Working Teams for:
      • Impact Assessments
      • Change Controls
      • Deviations
      • CAPA
    • Conducts Data analysis and authors trending reports
    • Serves as SME for applicable studies during regulatory inspections
    • Serves as Document Owner for procedures and work instructions in support of the Stability and Sample Management programs.
    • Monitors regulations for changes that impact process, updates process as required
    • Identifies and generates process related metrics- monitors for efficiency
    • Generates metrics for stability and sample management programs
    • Reports risks related to stability to Quality System Owner(s)
    • Reports Events related to stability programs
    • Assesses stability requirements for new products and new dosage forms
    • Provides stability data for regulatory filings
    • Provides stability summaries for annual product review
    • Authors Change controls and assesses stability impact on proposed changes


    • A minimum B.A. or B.S. in biochemistry or related scientific field.
    • A minimum of 8+ years of QC Stability experience in a biotechnology/pharmaceutical industry.
    • Strong knowledge of ICH stability guidelines.
    • Deep experience and strong understanding of ICH stability guidelines.
    • Excellent judgment and creative problem-solving skills.
    • Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment.
    • An excellent and persuasive communicator.
    • Energetic, flexible, collaborative and proactive; a team leader who can positively and productively impact initiatives.

    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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