Ready to join a team committed to moving gene therapies into the clinical setting 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 at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.
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.
• 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.
• 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.
• 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.
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.