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Quality Control Specialist, Analytical Science and Technology

Company: AveXis Inc.
Location: Durham
Posted on: September 14, 2019

Job Description:

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 Global Quality Control (QC) team. The individual will collaborate closely with contract testing labs and contract manufacturing organizations as well as the Project Management team to qualify, validate, transfer and improve analytical methods. She or he will play an active role in establishing the site QC lab operations to support development and commercialization of new gene therapy medicines. The Analytical Science and Technology Specialist is responsible for participating in method qualification, validation, transfer, and improvement, along with management of the critical reagent program. The Specialist will possess a strong understanding of Quality Control (QC) testing operations and provide expertise in several QC assays, such as cell-based potency, ELISA, qPCR, and separation assays. The Specialist will work independently on problem solving, lab investigations, and implementation of preventative and corrective actions. He/she will be able to work effectively within the group and Quality as well as across sites. Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations and effective interactions/communication with Quality management. Responsibilities Lead the critical reagent program, including qualification, bridging, and inventory management. Write and revise documents such as SOPs, method validation/transfer protocols, 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. Support identification and implementation of new technologies to improve the compliance and efficiency of QC operations. Represent QC to work with other departments including Analytical Development, Quality Assurance, Manufacturing, and contract testing labs to address compliance issues, implement corrective actions and improve programs. Support assay troubleshooting, qualification, validation, and transfer. Review and trend QC testing results. Perform other related duties as assigned. Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 5 years of experience with biological products in a GMP Quality Control laboratory. Experience in critical reagent programs (e.g. reference standard qualification, bridging, inventory management, etc.) is strongly desired. Excellent oral and written communication skills with strong technical writing experience required. Approximately 15% travel 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. #LL1-TT1

Keywords: AveXis Inc., Durham , Quality Control Specialist, Analytical Science and Technology, Other , Durham, North Carolina

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