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Quality Control Supervisor (PCR) - Second Shift

Company: AveXis Inc.
Location: Durham
Posted on: September 15, 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, 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. The Quality Control (QC) Group is part of the Quality organization and is responsible for testing of raw materials, in-process, release, and stability samples. The QC Supervisor will be both performing testing and overseeing testing performed by QC Analysts. In this role, they will supervise a team of QC Analysts. Additionally, the QC Supervisor will review data, perform administrational duties associated with a leadership role, and actively perform testing if needed. The successful candidate will work in a cGLP environment and must have working knowledge of a QC environment, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded. Skills in statistics required to effectively analyze trends is also desired. Responsibilities Oversee the daily activities within the QC department in an efficient manner, assuring that the AveXis core values (Integrity, Tenacity, and Teamwork) are reinforced. Perform testing, data review, data analysis, etc. Perform mid-year and end of year evaluations. Lead and coach a team of QC Analysts. Drive testing efficiencies in order to reduced testing time and costs, improve compliance, and reduce safety risks. Contribute to investigations in the laboratory resulting from invalid assays, unexpected test results and deviations from standard protocol. Assure training is up to date for the team. Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. Support strategic proposals, progress updates and presentations to all levels of the site organization. Qualifications Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience. Minimum 6 years of relevant experience in a GMP testing laboratory preferred. Prior leadership experience is desired but not required. Prior experience testing in a GLP environment is required. Ability to work off-shift hours. Investigational stills with respect to laboratory investigations required. Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting. Must be proactive, action oriented, and have the ability to adapt to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track. Must have strong communication skills both verbally and written. Must have proven logic and decision-making abilities, critical thinking skills. Must be able to accommodate testing schedule as required. The ability to effectively communicate at all levels of the organization is 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. #L1-TT1

Keywords: AveXis Inc., Durham , Quality Control Supervisor (PCR) - Second Shift, Other , Durham, North Carolina

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