Quality Control Analyst (PCR) - 2nd Shift

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. The individual will collaborate closely with the Analytical Development team to transfer 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. The candidate must adhere to all GMP requirements, FDA/EMEA regulations and needs to work effectively within the group, within Quality, and across site. The QC Analyst may also support and identification and implementation of corrective and preventive actions.

Responsibilities

• Perform established analytical methods such as ddPCR (Digital PCR) and qPCR (Quantitative PCR) for in-process, release, or stability samples.
• Perform other routine QC testing such as Physical testing (pH, appearance, osmolality, sub-visible particulates), HPLC, SDS-PAGE, Western Blot, etc.
• Participate in assay troubleshooting, qualification and validation as 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 directly related scientific field.
• 0-2 years cGMP lab experience.
• Working knowledge of assay theories and ability to practice proper analytical techniques.
• Excellent oral and written communication skills.
• Solid technical writing experience.
• Ablity to work 2nd shift within a 24 x 7 cGMP Manufacturing enviornment.

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.