Director, Quality Control Microbiology- Manufacturing (Gene Therapy)

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 Director of QC Microbiology is responsible for overseeing all cGMP Microbiology testing including environmental monitoring for AveXis Inc. The incumbent will be a key member of the management team and will be responsible for the design, implementation, and continuous improvement of all processes/systems in support of the AveXis Manufacturing plant sterility assurance program. In addition, the he/she will be responsible for developing and executing AveXis' corporate quality policies, practices, procedures, standards, and systems necessary to ensure adherence to aseptic production and product management in accordance to the cGXP compliance to US and EU regulations.

Responsibilities

• Oversee the overall Quality Control Microbiology laboratory strategy and operation, with a concentrated focus on facility utilities, environmental classification and control design, program design for Microbiology laboratory equipment, and facility qualification/control.
• Oversee the Aseptic Gowning and Training Program.
• Maintain a robust Environmental Monitoring program that meet US/EU and other applicable regulatory requirements.
• Organize and direct cross functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory.
• Hire staff and manage contract vendors for programs related to the QC Microbiology laboratory.
• Direct laboratory staff, set goals and expectations, and maintain efficient utilization of resources.
• Author and approve documents required for regulatory submissions.
• Develop, implement and enforce Microbiology laboratory procedures and policies.
• Ensure continued professional development of staff through training and functional interactions with various operating groups.
• Provide presentations, explain laboratory qualification and operations, and defend testing results during FDA and other inspections.

Qualifications

• BS/MS in Microbiology discipline and 12+ years of experience in a cGMP microbiology testing laboratory environment, with strong knowledge of regulatory, USP and Eur. PHr guidelines as related to Microbiology issues, aseptic processing, and bio-safety. Ph.D. in life sciences is preferred.

• 8+ years of laboratory management experience.

• Experience starting up lab facilities supporting clinical and/or commercial manufacturing.

• Experience with regulatory agency inspections.

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.