Senior Quality Control Specialist - Biochemistry
Company: AveXis Inc.
Posted on: February 15, 2019
OverviewReady 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 at the Durham, NC 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 requireThis position will be based out of our Manufacturing site located in RTP, NC.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.
Keywords: AveXis Inc., Durham , Senior Quality Control Specialist - Biochemistry, Other , Durham, North Carolina
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