Scientist I, Analytical Development (Bioassay)

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 a highly motivated scientist to join the dynamic and growing analytical development team. He/she will mainly be responsible for assisting with the development of phase-appropriate cell-based assays for drug substance and drug product stability and relative potency studies. He/she will also participate in exploratory studies that will evaluate and introduce new technologies to existing assay platforms.

Responsibilities

• Plan and execute experiments that contribute to bioassay development, optimization, qualification/validation of MOA-reflective potency assays suitable for drug product stability studies and lot disposition.
• Assist in authoring of technical reports and SOPs.
• Support tech transfer of methods to internal QC group and/or CROs.
• Work with junior research associate on experimental design, troubleshooting, assay optimization and data interpretation as needed.
• Interpret and present data at group and department meetings.
• Collaborate within Bioassay group and provide support to collaborating functional groups as needed.
• Participate in exploratory assay development efforts to bring new technologies or assays to Analytical development.

Qualifications

• B.S or M.S. in Cell Biology, Molecular Biology or related discipline.
• BS with 5-10 years or MS with 2-5 years of biopharma industry experience with knowledge and hands-on experience with various analytical methods (e.g. Fluorescence In situ hybridization, IF microscopy, FACS, ELISA, MSD, plate reader).
• Experience and understanding of phase-appropriate analytical assay development, qualification, and validation obtained from 1-2 years of experience in GxP environment.
• Experience with immune-fluorescence microscopy and high-content imaging and image analysis is highly preferred.
• Ability to troubleshoot experiments based on thorough understanding of assay principles.
• Ability to work in a face-paced team-orientated environment.
• Excellent written and verbal communication skills.
• Familiarity with virology and gene therapy is a plus.

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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