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.
The Director, Manufacturing Quality Assurance is responsible for designing and implementing innovative and robust processes for Quality review and release activities associated with a viral gene therapy manufacturing site which includes bulk product and sterile fill operations. This person will be responsible for developing the strategy for overall site quality operations including but not limited to: on-the-floor QA review activities which support a multi-shift manufacturing schedule, collaborating with Manufacturing operations to authorize written procedures such as: pre and post approval of batch production records, raw material/component specifications, facility related SOPs, calibration/maintenance documentation, consumable and raw material release. In addition, this individual will oversee and manage overall batch release activities to support a multi-product, multi-phase manufacturing scope and will bring a phase appropriate approach to the execution of quality oversight. This position will lead product quality reviews for the site and act as the primary liaison for QP related release needs.
Approximately 10% travel required.
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.