Manufacturing Specialist, Deviation/CAPA

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 Deviation/Corrective Action Preventative Action (CAPA) Specialist is responsible for providing support to the engineering, validation, MSAT, maintenance, QC and QA groups at a site. The Deviation/CAPA Specialist will be responsible for investigating complex deviations and supporting the applicable CAPAs discovered in the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure our programs and manufacturing are in a state of control and all non-conformances are managed within the given timelines.

Responsibilities

• Provide complex deviation/CAPA support for the manufacturing process owners/groups.
• Participate in the site deviation/CAPA forum and ensure collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions are aligned with investigation progress and results.
• Serve as a lead investigator for complex deviations, escalating issues as required.
• Serve as a lead investigator/mentor for non-complex deviations owned by other groups.
• Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Requires direct input on the creation and effectiveness of corrective and preventive action plans. Assist with implementation and supporting on-going continuous improvements.
• Identify, develop and implement process robustness improvements through lean principals.
• Support internal and external audits for complex deviations.
• Support the PMO group for any technology transfer activities.
• Support site change controls as needed.
• Responsible for maintaining quality standards to meet GMP requirements, CFRs and internal company policies with respect to the Deviation/CAPA process.

Qualifications

• Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools.
• In-depth knowledge of FDA regulations and GMP systems and experience interacting with various regulatory agencies 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 (~10%).

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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