Scientist, Quality Control (cGMP Commercial Release)

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.

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 Scientist to join the dynamic and growing quality control team to perform bioassays suitable for lot disposition and characterization of gene therapy drug products and substances.

The individual will play a crucial role for the performance 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. 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

• Perform 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 release and characterization assays for gene therapy products.
• Thorough understanding of quality systems and experience leading investigations, non-conformances, change controls,
• Advanced technical writing skills.
• 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. Author SOPs, method transfer/qualification/validation protocols, and reports.

Qualifications

• B.S or M.S in biology discipline is required.
• 5 years of directly related BioPharma industry experience is required.
• Strong understanding of regulatory agency guidance such as FDA, ICH and EMA and hand-on experience is a significant plus.
• Must have good cell culture techniques with good understanding of cell behavior and biology.
• Demonstrated track record of successfully executing cell-based assays using various assay platforms including but not limited to ELISA, MSD, ELISpot and high-content imaging in 96 well plate setting in a cGMP laboratory.
• Prior vivarium experience and direct exposure to/handling of mice a plus.
• 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.

This position will be located out of our San Diego offices.

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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