Quality Control Analyst (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 QC Microbiology Analyst performs Environmental Monitoring and Microbiological testing in support of manufacturing at the AveXis GMP Manufacturing facility. The QC Microbiology Analyst responsibilities include, but are not limited to, routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes, participate in method and instrument qualifications, and support investigative testing. A potential candidate will possess working knowledge of QC Microbiological/Cell Culture/Environmental Monitoring testing techniques. The QC Analyst should be able to work effectively within the group, within Quality, and cross functionally.

Responsibilities

• Perform environmental and utilities monitoring in clean rooms.
• Perform bioburden, endotoxin and cell culture assays.
• Perform data entry.
• Assist in drafting and revising SOPs and reports.
• Trend EM data and publish quarterly and annual trend reports.
• Assist with investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Establish and maintain library of environmental isolates.
• Assist in assay troubleshooting, qualification and validation.
• Manage the use and maintenance of scientific equipment and instrumentation and computer systems.
• Perform other duties as assigned.

Qualifications

• Minimum B.A. or B.S. Microbiology or in scientific related field.
• Minimum of 2 years in a GMP Quality Control Microbiology/ Environmental Monitoring laboratories, preferably in a biologics aseptic processing facility.
• Working knowledge of Environmental Monitoring and Microbiological Assays (e.g. Bioburden, Endotoxin, Gram Stain, and Sterility).
• Good understanding and demonstration of aseptic techniques.
• Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP, JP).
• Proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work in a team environment.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Ability to think critically and demonstrate troubleshooting, and problem-solving skills
• Excellent interpersonal, verbal, and written communication skills.

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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