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Manufacturing Specialist, External Manufacturing

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 Manufacturing Specialist to provide support to Clinical and External Manufacturing Partners. Must be highly motivated, organized, solution-oriented, and efficient with strong technical aptitude and the ability to work effectively with multiple team members. This will be a fast-paced role within a cross functional project team. Responsibilities Supports strategic goals to deliver multiple rare disease blockbusters by overseeing on-the-floor operations at CMO partners. Becomes an expert at the CMO regarding the manufacturing process, documents, and systems, with the ability to provide troubleshooting assistance on and off the floor when issues arise. Works closely with external manufacturing partners (i.e., Plasmid suppliers, drug substance manufacturers) and internal manufacturing sites to develop project plans, risk mitigation strategies and timelines/milestones for external production. Tracks progress, including coordinating the reporting of the KPIs. Manages process by ensuring smooth operation of external collaborations, such as project team meetings, data exchange, and other kinds of interactions. Supports efforts to increase alignment and mutual understanding between collaboration participant. Interfaces with internal functional group leaders including Engineering, Manufacturing, Quality Control, Quality Assurance, and Supply Chain to ensure aligned strategies and timelines. Assists with inventory management and shipment of materials between sites. Supports technology transfer activities. Drives change controls and document revisions at CMO. Reports on project progress identifying issues and risks and offering viable solutions and opportunities as they arise. Qualifications Bachelor's degree required. 5 years of relevant experience. Cell culture experience required. GMP manufacturing-related experience required. Proven ability to manage multiple high-level parallel tasks effectively using technology (i.e. MS Project, Power Point), work unsupervised and possess the ability to apply new techniques using strong prioritization skills. Must display effective planning, organizational, and critical thinking skills, innovativeness, and keen attention to detail and excellent follow through. The incumbent must have strong interpersonal skills. Up to 75% US based travel 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 , Manufacturing Specialist, External Manufacturing, Other , Durham, North Carolina

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