Manufacturing Specialist

Overview

Ready 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.

The Manufacturing Specialist is responsible to support the primary manufacturing process owner and the manufacturing group by providing required process input to the engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyville manufacturing sites. The Manufacturing Specialist will be the owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site.

Responsibilities

• Support the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support).
• Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites.
• Serve as a manufacturing document owner for certain production process steps.
• Own critical manufacturing deviation investigations and define pragmatic and effective CAPAs.
• Identify, develop and implement process robustness improvements through lean principals.
• Lead process specific training for the direct manufacturing group.
• Support internal and external audits for manufacturing process steps.
• Support the PMO group for any technology transfer activities.
• Own manufacturing process related change controls.
• Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process.
• Responsible for providing manufacturing SME support on capital related projects.

Qualifications

• Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations.
• Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations.
• In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility.
• Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Travel as required to other internal sites, vendors, and CMOs as required (~20%).

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.