Director, Global Sterility Assurance

Overview

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 of Sterility Assurance serves as the key functional expert for the Global Aseptic processing function in the AveXis network. This person will be responsible for providing the technical leadership, direction and management of the sterility assurance quality operations to support viral gene therapy products. This includes development/optimization of current processes and programs to ensure compliance with regulatory requirements, implementation of Annex 1, organization development, and making appropriate decisions and recommendations to address trends, issues or significant observations related to sterility assurance.

The Sterility Assurance Director also acts as the owner of the global quality sterility assurance initiatives, working with senior stakeholders such as the site operations and quality heads, Novartis representatives and AveXis senior quality leaders to ensure global sterility assurance support is provided.

Responsibilities

• The Director Sterility Assurance provides technical leadership for sterility process assurance and microbial control for viral gene therapy products as required to assure compliance with cGMP and regulatory requirements.
• Provide expert advice and appropriate technical support to ensure site readiness for regulatory and internal inspections by supporting sites in their preparation.
• Lead and support investigations for microbial contamination events and help establish root cause and CAPA.
• Direct AveXis team in the justification of microbial controls and limits for viral gene therapy products.
• Drive implementation of new technologies related to microbial monitoring and controls.
• Primary for optimization and uniformization of aseptic techniques, cleaning and disinfection programs, microbiological monitoring and sterilization techniques between sites within the network.
• Provides technical expertise for marketed and clinical products and can represent the company in discussions with regulatory agencies. Also provides support for regulatory audits and filings.
• The scope of activities for the teams includes interactions with R&D, Operations, Quality, Commercial and regulatory as well as the relevant technical plant support functions both within AveXis and at third party manufacturers.
• Lead cross site/platform and network projects such as the Annex 1 implementation.

Qualifications

• Minimum B.S. degree in scientific or technical field preferably in Microbiology. Master's Degree and/or PhD is preferred.
• A minimum of 8-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in managing sterility assurance programs for biotechnology manufacturing facilities. Experience with viral gene therapies and/or orphan disease indications is a plus.
• Deep understanding of microbiology and aseptic processes.
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
• Excellent verbal, written communication skills and the ability to interface with multiple areas within the organization is essential.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward for microbial contamination events.
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
• The global nature of the job requires the position to have excellent knowledge of the various regulatory and GMP requirements as well as outstanding communication skills.
• Approximately 25% 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.

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