Technical Operations Specialist

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 Technical Operations Specialist that will be responsible for the global manufacturing process for the AVXS platform providing required network operations input to the engineering, validation, Manufacturing Science and Technology (MSAT), maintenance, QC and QA groups across all network manufacturing sites. The Technical Operations Specialist will be the primary platform expert for the upstream, downstream, fill/finish process or manufacturing support.

Responsibilities

• Serve as the manufacturing process owner for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support), representing the entire AveXis network.
• Ensure process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at all production sites.
• Serve as the global document owner for designated multi-site documents associated with the assigned production area.
• Provide network support for critical manufacturing deviation investigations, define and or approve pragmatic and effective CAPAs, and lead network operationalization of learning and project manage network improvements.
• Support cross functional and cross site global matrix team to Identify, develop and implement process robustness improvements through lean principals as indicated by platform updates.
• Provide governance, facilitate meeting occurrences, plan agendas, maintain project/topic trackers and execute or manage work as indicated.
• Develop and maintain communication plans.
• Develop and lead process specific training for the network manufacturing group.
• Support technology transfer project management activities as requested.
• Own global change controls and monitor and assign site change plans for completion by sites.
• Responsible for maintaining quality standards to meet GMP requirements, CFRs and internal company policies with respect to the manufacturing process.
• Responsible for either leading or providing manufacturing subject matter expert support on capital related projects.

Qualifications

• Minimum B.S. degree in Engineering or the life sciences and 8 years of work experience in biopharmaceutical based GMP manufacturing operations.
• Experience with matrix teams preferred with previous dotted line leadership preferred.
• 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 (~30%).

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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