Senior Quality Control Specialist (Biochemistry)

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 our Durham site. The individual will collaborate closely with Analytical Development, Quality Control, and Project Management teams 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 Sr QC Specialist is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification, validation, transfer, and improvement.

The candidate should possess strong understanding of QC testing operations and provide expertise in several QC assays, such as cell-based potency, ELISA, qPCR, and separation assays. She or he is expected to 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, within Quality, and across sites. Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations, effective interactions/ communication with Quality management. Experience in cell culture and cell-based assays (e.g. virus infection assays and proliferation assays) is desired.

Responsibilities

• Serve as SME in several QC assays, such as cell-based potency, ELISA, qPCR, and separation assays.
• Perform QC assays for in-process, release, or stability samples.
• Review and trend QC testing results.
• Lead assay troubleshooting, qualification, validation, and transfer.
• Manage the procurement, implementation, use, and maintenance of equipment, instrumentation, and computer systems.
• Write and revise documents such as SOPs, method validation/transfer protocols, and technical reports.
• Lead investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Identify and implement new technologies to improve the compliance and efficiency of QC operations.
• Represent QC to work with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs.
• Perform other related duties as assigned.

Qualifications

• Minimum B.A. or B.S. in biochemistry or related scientific field.
• Minimum of 8 years of experience preferred with biological products in a GMP Quality Control laboratory.
• Excellent oral and written communication skills with strong technical writing experience required.
• Potential for up to 20% travel required.

This position will be based out of our Manufacturing site located in RTP, North Carolina.

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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