• Quality Control Microbiology Supervisor

    Job Locations US-IL-Libertyville
    Posted Date 3 weeks ago(3 weeks ago)
    Job ID
    2018-1226
    # 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.

     

    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.

     

    We are seeking a highly motivated individual to join us as a QC Microbiology Supervisor in our new gene therapy production center located in Libertyville, IL.  You will work with the Quality Control team in supporting our efforts in this exciting new area of gene therapy. In this role you will be responsible for the day to day oversight of the QC Microbiology team. You will also be responsible for the environmental and utilities monitoring, raw material testing, and final product testing. This position is for 2nd Shift.

    Responsibilities

    • Supervision of all QC Micro laboratory testing.
    • Sustain environmental monitoring program for AveXis.
    • Management and optimization of the Aseptic gowning training and qualification program.
    • Management of  QC Microbiology training program.
    • Work with QC raw materials team to establish specifications and testing process of raw materials. 
    • SME on investigations of sterility failures and environmental excursions.
    • Monitor and trend data
    • Assemble reports on findings from environmental monitoring of Avexis’s cGMP facility.  Frequently update management on environmental trends.  Implement corrective action plans when necessary.
    • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
    • Develop, revise and review SOPs, qualification/validation protocols and reports.
    • Conduct investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro procedures.
    • Provide updates at daily and weekly meetings.
    • Monitor the GMP systems currently in place to ensure compliance with documented policies.
    • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
    • Gather metric information for use in continuous improvement of areas of responsibility.
    • Other duties as assigned.
    • NOTE: Shift may include weekends and second shift hours.

    Qualifications

    • Bachelor's degree or advanced degree in Microbiology or related discipline.
    • Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
    • A minimum of 5 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required.  A minimum of  1 year experience supervising/managing/leading microbiology  and environmental monitoring labs within the biotechnology or pharmaceutical industry.
    • The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell/gene therapy product.
    • Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes.
    • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs.
    • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, cGMPs, microbiological method development and validation.
    • Strong data integrity knowledge and practices.
    • Identifying, writing, evaluating and closing OOS investigations.
    • Strong knowledge of aseptic manufacturing and EM processes.
    • Equipment and utility IQ/OQ/PQ/PV.
    • Proficient in MS Word, Excel, Power Point and other applications.
    • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
    • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

     

    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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