Quality Control Analyst (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 (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 and solution-driven individual to join the dynamic and growing Quality Control (QC) team. The individual will collaborate closely with Analytical Development team to qualify/validate analytical methods and establish the site QC lab operations to support development and commercialization of new gene therapy medicines. The QC Analyst is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification/validations.

A potential candidate should have enriched experience in culturing transformed and primary cells and banking cells. In addition, experience in testing samples using qualified cell-based assays (e.g. virus infection assays and proliferation assays) is desired. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support and identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across site.

Responsibilities

• Perform cell-based potency and impurity assays for in-process, release, or stability samples.
• Perform other established analytical methods such as qPCR and CE to support QC operations.
• Participate in assay troubleshooting, qualification and validation if needed.
• Manage the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems.
• Write and revise documents such as SOPs and technical reports.
• Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs.

Qualifications

• Minimum B.A. or B.S. in biochemistry or related scientific field.
• Minimum of 1 year GMP lab experience and at least 2 years of industry experience working on tissue culture and cell-based assays associated with biologics products.
• Excellent oral and written communication skills with strong technical writing experience required.

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.

#L1-TT1