Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.
AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.
As part of the Manufacturing organization, the Quality Control (QC) Investigations Specialist will be responsible for the investigation and completion of laboratory investigations and non-conformances aimed at identification of root cause, assessing potential impact and implementation of corrective and preventive actions. The QC Investigations Specialist will help determine the validity of data, and determination of out of specification results. The successful candidate will work in a cGLP environment and must have a working knowledge of biopharmaceutical QC testing operations, 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 bioassays, PCR, and microbiological assays. 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.