Associate Director, Quality Control (Microbiology)

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 Associate Director of Quality Control (QC) Microbiology is responsible for management and operation of all cGMP Microbiology testing including environmental monitoring for a site. The incumbent will be a key member of the management team and will be responsible for the continuous improvement of all processes/systems in support of the AveXis Manufacturing plant sterility assurance program. In addition, he/she will be responsible for 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 global regulations.

The position requires demonstrated leadership, as well as operational experience in a Quality Control laboratory setting.

Responsibilities

• Oversee the Quality Control Microbiology laboratory operations including reporting on laboratory metrics and identifying new metrics focused on monitoring for potential issues and continuous improvement.
• Oversee the Aseptic Gowning and Training Program.
• Maintain a robust Environmental Monitoring program that meet US/EU and other applicable regulatory requirements.
• Ensure product testing is performed in a timely manner.
• Generate and manage capital, contract services and personnel budgets for areas of responsibility.
• Approve laboratory investigations and nonconformance investigations and ensure they are completed in a timely manner.
• 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 setting goals and expectations and maintain efficient utilization of resources.
• Provide direction to technical leads for projects
• Author and approve documents. Review SOPs, protocols, policies, and reports.
• Oversee external Microbiological testing and investigations.
• Develop, implement and enforce Microbiology laboratory procedures and policies.
• Ensure continued professional development of staff through training and functional interactions with various operating groups.
• Represent Microbiology at daily operations leadership team meetings and during Regulatory inspections.
• Implement LIMS for QC laboratories.

Qualifications

• BS/MS in Microbiology discipline (or biological sciences) and 12+ years of experience in an aseptic processing cGMP microbiology testing laboratory environment, with strong knowledge of regulatory, USP and Eur. Phr guidelines as related to Microbiology issues, environmental monitoring, aseptic processing, and biosafety.
• Prior experience in QC microbiology in a manufacturing facility for biological products is required.
• Experience in cell or gene therapy highly desired.
• Minimum of 5 to 8 years of laboratory management experience, of increasing scope and complexity is required.
• Prior experience with representing microbiology in regulatory inspections is required.
• Previous experience qualifying methods for regulatory submissions is required, and experience with validating methods is highly desired.
• Previous experience qualifying analytical instruments.
• Ability to work with others to troubleshoot complex technical and scientific problems
• Able to react to change productively and handle other essential tasks as assigned.
• Good working knowledge of Excel, Powerpoint, and laboratory information systems.

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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