• Senior Scientist, Analytical Development Laboratory

    Job Locations US-NC-Durham
    Posted Date 2 weeks ago(4/4/2019 6:22 AM)
    Job ID
    2019-3208
    # 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 (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.

     

    AveXis is seeking an experienced and exceptional Senior Scientist to join the dynamic and growing analytical team to establish analytical methods suitable for lot disposition and characterization of gene therapy drug products and substances.

     

    The individual will play a crucial role for the development and optimization of cell-based potency and other functional bioassays in a team environment.  In addition, he/she will participate (or lead) method qualification/validation in a cGMP setting and may be involved in the method transfer to internal and/or external QC laboratories.  Responsibilities will also include execution of routine assays and supporting lab operation.  Successful candidate will have extensive experiences in tissue culture work and will be a fast-learner with passion for new technology and science.

    Responsibilities

    • Optimize and troubleshoot cell-based assays as well as other plate-based assays using variety of platforms including but not limited to ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader in support of developing release and characterization assays for gene therapy products. Thoroughly document optimization and troubleshooting processes.
    • Actively engage in planning and designing of assays/experiments and take ownership of assays/experiments one is performing by understanding the purpose, rigidly following through every step of execution, thoroughly analyzing data and ensuring the data quality.
    • Maintain clean and fully functional cell culture area by implementing TC room policy and take ownership of on-going cultured cells by thoroughly documenting cell passage, morphology and behavior and routinely performing tests for contamination. In addition, create cell banks and oversee their inventory.
    • Play an important role in qualifying and validating cell-based assays. Help documenting assay development, qualification and validation processes as well as SOPs.
    • Collaborate with R&D for knowledge transfer during assay development and work closely with QC for method transfer. Be actively involved (both as trainee and trainer) in cross-training of lab personnel.
    • Perform experiments in support of assay development using variety of techniques covering cell biology, biochemistry and molecular biology such as immunocytochemistry, western blot, qPCR, flow cytometry, and immunoprecipitation.

    Qualifications

    • B.S or M.S in biology discipline is required.
    • Minimum 10 years of biopharma industry experience is required for B.S and minimum 7 years of biopharma industry experience is required for M.S.
    • Basic understanding of regulatory agency guidance such as FDA, ICH and EMA and hand-on experience is a significant plus.
    • Working knowledge in DOE is a significant plus.
    • Must have very strong cell culture techniques with good understanding of cell behavior and biology to be able to independently determine health and performance of cells that are used in critical assays.
    • Extensive experience in cell staining in 96well plate setting and knowledge of screening for antibodies and staining reagents for optimization and selecting for immunofluorescent dyes.
    • Demonstrated track record of successfully optimizing and executing cell-based assays using various assay platforms including but not limited to ELISA, MSD, ELISpot and high-content imaging in 96/384 well plate setting.
    • Broad experiences in cellular, biochemical and molecular biological methods including but not limited to immunostaining, flow cytometry, protein gel, Western blot, PCR and qPCR.
    • Enjoy learning and challenges. Especially, must be able to learn new instrument and master their software quickly.
    • Ability to work in a fast-paced small but growing team environment and to prioritize work from multiple projects. Must be highly reliable and goals/deadlines oriented.
    • Intelligent individual who respects others and is open to new/different ideas.
    • Must have exceptional organizational skills.
    • Excellent written and verbal 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.

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