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Senior Scientist, Analytical Chemistry (Assay Qualification)

Company: AveXis Inc.
Location: San Diego
Posted on: September 15, 2019

Job Description:

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 help qualify and transfer analytical methods to QC for lot disposition and characterization of gene therapy drug products. He/she will be mainly responsible for the analytical method qualification and validation under phase-appropriate GMP and will also be part of the method transfer and training team for successful transfer of the in-house qualified or validated assay to internal or external QC laboratories. He/she will have the ability to guide other group members to ensure compliance with cGMP requirements and global regulations. Responsibilities will also include preparing/reviewing documents including SOPs, qualification/validation protocols and reports. The role will involve laboratory work and provide leadership within analytical chemistry team in assay qualification/validation and method transfer. Responsibilities Key contributor within analytical chemistry group on method qualification/validation and method transfer to QC group. Serve as a technical resource in compliance requirements, documentation preparation and instrumentation/software requirements related to method qualification/validation/transfer. Coordinate with vendors/consultants for analytical instrument qualification to ensure the compliance required for method qualification. Serve as a liaison between analytical chemistry group and QC department in analytical method transfer, validation and troubleshooting. Responsible for authoring/reviewing SOPs, protocols and technical reports. Ensure analytical chemistry group is in compliance with global regulatory requirements while performing method qualification. Work closely with functional groups (for example, QC/QA, process sciences and manufacturing groups) to ensure win-win collaboration in qualifying/validating/transferring analytical methods suitable for characterization, stability, and release testing purpose. Qualifications Ph.D. or M.S. in analytical chemistry or related scientific discipline is required. 5-8 years (Ph.D.) or 8-10 years (M.S.) of Biopharma industry experience and 3-5 years of GMP experience in qualifying and/or validating analytical methods is required. Extensive experience in analytical method qualification/validation under ICH/FDA guidance and compliance requirements. Good working experience and understanding on instrument IQ/OQ/PQ. Good practice and understanding of data integrity in analytical lab whiling performing assay qualification/validation. Good working knowledge with 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. In-depth understanding and troubleshooting capability of analytical instrumentation and software (including but not limited to HPLC, CE, FFF, MALS, DLS, Chromeleon, Empower, Astra, 32 Karat). Working experience on antibodies, vaccines, gene therapy drugs or nanoparticle drug deliveries are required. Strong technical writing skills and experience in authoring instrument/method SOPs, qualification protocols and reports with detail-oriented trait. 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 #LI-EC1

Keywords: AveXis Inc., San Diego , Senior Scientist, Analytical Chemistry (Assay Qualification), Other , San Diego, California

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