Senior Quality Control Microbiologist (Environmental Monitoring Specialist)

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 (ZOLGENSMA®). 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.

AveXis is seeking a highly motivated individual to join us as a Quality Control (QC) Senior Microbiologist. This position works with the Quality Control team supporting our efforts in this exciting new area of gene therapy. This role will be responsible for providing technical support to QC and Manufacturing related to Environmental Monitoring (EM) and Sterility Assurance.

Responsibilities

• Partner with Manufacturing and Facilities to address facility environmental and utilities excursions. Support resolution of problems identifying trends and determining system improvements.
• Review and approve investigations related to environmental excursions.
• Generate metrics and oversee environmental monitoring trends and reports.
• Oversee environmental monitoring risk assessments.
• Oversee annual alert level assessments.
• Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
• Partner with Manufacturing to champion the company's compliance to aseptic procedures and practices in accordance with current regulatory requirements and industry guidance.
• Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations.
• Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state.
• Develop, revise and review SOPs, qualification/validation protocols and reports.
• Train staff on technical concepts and methods.
• Review laboratory data.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree or advanced degree in Microbiology or related discipline.
• A minimum of 8 years' experience working in a GMP QC Microbiology/Environmental Monitoring laboratories, preferably in an aseptic processing facility. A minimum of 3 years' experience with Environmental Monitoring investigations.
• Ability to gown for entry into Aseptic core and supporting areas and lift approximately 25 pounds.
• Well versed in various environmental monitoring techniques including rapid methods, and qualifying environmental monitoring processes with reference to cell and gene therapy products.
• Must be familiar with implementation of microbiological environmental monitoring programs and must understand interpretation of microbiological data including evaluation of trends.
• Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP).
• Experience in performing EM risk assessments.
• Extensive experience in conducting laboratory and environmental excursion investigations.
• Strong knowledge of equipment IQ/OQ/PQ/PV.
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills. Ability to communicate and work independently with scientific/technical personnel.
• Self-motivated, detail-oriented, comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Experience managing projects.
• Experience drafting qualification/validation protocols and reports. Experience executing equipment and method qualifications independently.

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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