Senior Scientist, Analytical Development (Mass Spectrometry)

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 mass spectrometry based analytical methods suitable for characterization of gene therapy drug products and substances.

Responsibilities

• Act as a key expert in selecting mass spectrometry instrumentation and data analysis software suitable for LC-MS/MS characterization of gene therapeutics.
• Independently design experiments and develop mass spectrometry-based methods for thorough characterization of gene therapy products, including AAV protein intact mass, peptide mapping, post-translational modifications, impurities, HCPs, etc.
• Serve as SME to work with CROs to ensure LC-MS method is robustly developed and the results are scientifically sound. Actively participate in the scientific discussion and provide input/feedback.
• Proactively giving suggestions on novel technologies suitable for better characterization of AAV gene therapeutics.
• Work closely with functional groups (e.g. R&D, QC/QA, process development, manufacturing groups) to ensure win-win collaboration in developing and transferring analytical methods suitable for characterization, stability, and release testing purpose.
• Effectively communicate results both internally and externally via presentations or written reports.
• Author and review SOPs and technical protocols/reports; contribute to data generation, interpretation and summarization in support of regulatory filings including IND and BLA.
• Mentor and train junior group members on daily laboratory work, experimental design, data interpretation and troubleshooting.

Qualifications

• Ph.D. in analytical chemistry or related scientific discipline is required. 5-8 years of post-graduate LC-MS experience on protein characterization is required. 3-5 years of biopharma industry experience is preferred.
• Good working knowledge with LC-MS, LC-MS/MS for intact mass analysis, peptide mapping, PTM, impurities, HCP analysis of protein/vaccine/gene therapy products, as well as MS quantification.
• Good working experience in MS instrumentation and software, including but not limited to Thermo orbitrap mass spectrometer, Xcalibur, Biopharma Finder, PEAKS, Byonic/Byologic/Biomap, Protein deconvolution, etc.
• Previous working experience on antibodies, vaccines, viruses, gene therapy drugs are required.
• Good understanding on a broad spectrum of analytical techniques (including but not limited to SEC, FFF, IEC, RP-HPLC, HIC, HILIC, CE-SDS, iCIEF, CZE) for lot disposition and characterization of biologics drug product candidates is highly desired.
• Strong technical writing skills and experience in authoring development reports and SOPs with detail-oriented trait.
• 1-3 years of GxP experience in qualifying and/or validating analytical assays is preferred.
• Highly motivated, hard-working and detail oriented. Strong ability to work in a fast-paced team environment with highly goal-oriented approaches and to prioritize work from multiple projects with can-do attitude is required.
• 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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