Quality Control Analyst

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.

AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team at the San Diego site. 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

LIMITED POSTING: EXPIRES ON 2/21/2020.

• 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. Prefer SDS-PAGE.
• 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. Prefer Molecular Biology.
• 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.
• Prefer candidates with at least 3 months AveXis temporary service time.
• 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. #LI-MG1