Senior Manager, Manufacturing Support and Training

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. 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 Senior Manager, Manufacturing Support will be responsible for multiple functions within the North Carolina site including technical training, NCR/CAPA authoring and investigation, ownership of major manufacturing related change controls, and finite scheduling. This is a leadership role reporting to the Site Head that provides support across site teams and requires understanding of multiple site functions as well as major business and quality systems.

The Senior Manager, Manufacturing Support may also provide training activities to other departments, making sure that all employees understand the importance of their job functions. In addition, this position will contribute to other quality system activities such as NCR/CAPA, inspection preparation and change control processes.

Responsibilities

• Lead and support individual departments to develop and execute employee qualifications for technical training.
• Write and review GMP documents such as Standard Operating Procedures and Batch Records.
• Create, update and modify training documents in the Learning Management System.
• Lead a team that authors and investigates NCR/CAPA's for manufacturing.
• Ownership of major manufacturing related change controls including tech transfer, capital projects and major process changes.
• Develop and maintain detailed, task-based manufacturing schedules (Finite) to support seamless multifunction activities at the site.

Qualifications

• Bachelor's degree in Life Science or Engineering field required
• 5+ years of experience in a GMP manufacturing or quality position with 3+ years of training in a GMP manufacturing pharmaceutical/biotechnology environment
• Understanding of FDA regulations and best practices for training and development
• Experience with GMP documentation management
• Good interpersonal skills and strong written/communication skills
• Energetic and detail oriented with strong organizational skills
• Experience with the Learning Management System ComplianceWire is a plus

Approximately 5 % 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.