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. 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.
The Production Support Group is a part of the manufacturing organization and is responsible for projects, change controls, investigations into non-conformances, CAPAs, continuous improvement projects, internal training and scheduling, and batch record/SOP authorship. The Associate Specialist will be responsible for initiating, driving, and tracking change controls related to manufacturing operations. The Associate Specialist will also be responsible for managing projects and owning the manufacturing project dashboard. Additionally, the successful candidate may be responsible for the investigation and completion of non-conformances aimed at identification of root cause, assessing potential impact as well as implementation of corrective actions and preventive actions. The successful candidate will work in a cGMP environment and must have working knowledge of biopharmaceutical manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded while performing investigations. Must have the ability to understand and problem solve in an environment that is focused heavily on Chemical and Biological issues. The successful candidate will understand the concepts incorporated in Quality Assurance in a GMP environment. Skills in statistics are required to effectively analyze trends.
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.