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Quality Control Specialist (Microbiology)

Company: AveXis Inc.
Location: Durham
Posted on: September 13, 2019

Job Description:

OverviewReady 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 (ZOLGENSMA--). 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 Quality Control Microbiology Specialist provides Environmental Monitoring/Microbiological support at the AveXis GMP Manufacturing facility. The QC Microbiology Specialist responsibilities include, but are not limited to, training, data review, routine testing, method qualification/validations, investigations, and technical writing. A potential candidate will possess a strong technical understanding of QC Microbiological/Cell Culture/Environmental Monitoring testing techniques. The QC Specialist should be able to work effectively within the group, within Quality, and cross functionally. Responsibilities

  • Perform Cell Culture Assays, Environmental Monitoring, and Microbiological testing.
  • Review and trend data and publish quarterly and annual trend reports.
  • Conduct thorough investigations to determine root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Liaise with other departments including Quality Assurance, Manufacturing, and Facilities to address compliance issues, implement corrective actions and improve programs.
  • Participate in assay troubleshooting, qualification, and validation.
  • Manage the use and maintenance of scientific equipment, instrumentation and computer systems.
  • Write and revise documents such as SOPs and technical reports. Qualifications
    • Minimum B.A. or B.S. Microbiology or in scientific related field.
    • Minimum of 5 years in a GMP Quality Control Microbiology/ Environmental Monitoring laboratories, preferably in a biologics aseptic processing facility.
    • Strong knowledge of Environmental Monitoring and Microbiological Assays (e.g. Bioburden, Endotoxin, Gram Stain, Microbial ID, and Sterility).
    • Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
    • Experience with method and instrument qualification.
    • Experience performing laboratory investigations and environmental monitoring excursion investigations.
    • Experience with classroom and on the job training (i.e. Microbiological Assays, Aseptic Techniques, and Aseptic Gowning).
    • Good understanding and demonstration of aseptic techniques.
    • Experience leading small teams and projects.
    • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/, ISO 14644-1, USP, EP, JP).
    • Proficient in MS Word, Excel, Power Point and other applications.
    • Ability to communicate and work in a team environment.
    • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
    • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
    • Ability to think critically, and demonstrate troubleshooting, and problem-solving skills.
    • Excellent interpersonal, verbal and written communication skills.
    • 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. #L1-TT1

Keywords: AveXis Inc., Durham , Quality Control Specialist (Microbiology), Other , Durham, North Carolina

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