Senior Manager, Quality Control Microbiology

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.

This role is responsible for overseeing all cGMP Microbiology testing including environmental monitoring for AveXis, Inc. RTP site. The incumbent will be a key member of the management team and will be responsible for implementation and continuous improvement of all processes/systems in support of the AveXis Manufacturing Plant Microbiology, EM and Aseptic Gowning Programs.

Responsibilities

• Manages implementation and maintenance of quality systems, including but not limited to, SOP's, deviations, and personnel training.
• Manages method qualification, protocol preparation, qualification execution, and report approval.
• Manages deviation and out-of-specification reports and investigations and tracking the effectiveness of preventive action.
• Oversees contract lab testing activities.
• Oversees the contamination control program, ensuring utilities and facilities conform to company standards and to regulatory requirements.
• Oversees environmental action level reports and investigations and trend reports and tracking the effectiveness of preventive actions.
• Coordinates testing including validation and qualification, and the dissemination of the results of those activities to the relevant customers.
• Analyzes data to provide proposals for future directions; capable of critical review.
• Makes recommendations for corrective action to assure conformity with quality specifications.
• Prepares and present department KPIs to senior and executive leadership.
• Responsible for meeting deadlines under a tight timeline and changing priorities.
• Experience managing department budgets.
• Support site external supplier audits as SME.
• Manages and provides expert knowledge in the day-to-day function of the Microbiology group.
• Identifies, recruits, and retains top-notch talent.
• Empowers employees to take responsibility for their jobs and goals.
• Coaches, mentors, engages and develops the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.

Qualifications

• Bachelor's degree or advanced degree in Microbiology or related discipline.
• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
• A minimum of 10 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility with strong knowledge of regulatory, USP and Eur. Phr guidelines as related to Microbiology issues, environmental monitoring, aseptic processing, and biosafety.
• A minimum of 5 years' experience managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry.
• The ideal candidate is well versed in various microbiological techniques including rapid release methods and qualifying environmental monitoring processes.
• Ability to gown for entry into Aseptic core and supporting areas, on an as-needed basis.
• Strong data integrity knowledge and practices.
• Strong knowledge of contamination control, disinfection, cleanroom design and operation, and aseptic techniques.
• Experience starting up lab facilities supporting clinical and/or commercial manufacturing.
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Flexibility to work weekends/overtime as needed.
• Must be capable of bending, lifting, moving and/or carrying up to approximately 25 pounds.
• Travel 10%.

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.