Production Support Specialist - Scheduler

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. 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 Production Support Group is a part of the manufacturing organization and is responsible for internal training and scheduling, investigations into non-conformances, CAPAs, change controls, continuous improvement projects, and batch record/SOP authorship. The Specialist will be primarily responsible for coordinating, developing, and managing manufacturing schedules on a daily basis with real time updates of routine and non-routine activities to increase efficiency and productivity. Additionally, the Specialist will be responsible to develop effective scheduling process to achieve production objectives. The successful candidate will also be responsible for on-boarding training of manufacturing employees and updates to manufacturing training materials. In addition, the Specialist may also support other functions of the Production Support Group including, but not limited to, investigations, CAPA, change controls, and projects.

The successful candidate will work in a cGMP environment and must have working knowledge of manufacturing 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. The successful candidate will understand the concepts incorporated in Quality Assurance in a GMP environment. Skills in statistics are required to effectively analyze trends.

Responsibilities

• Coordinate, develop, and manage manufacturing schedules on a daily basis with ability for real time updates of routine and non-routine activities to increase efficiency and productivity.
• Develop effective scheduling process to achieve production objectives.
• Analyze and address production issues related to scheduling in a real time.
• Monitors the Production Schedule on a daily basis and makes changes when necessary, such as when resources do not come out as planned, any changes in the production plan or when equipment fails.
• Oversee routine equipment maintenances to avoid outages and repairs during production.
• Manage production schedule to accommodate maintenance activities and non-routine requests.
• Develop and lead the on-boarding training for new manufacturing employees.
• Organize job trainings to staffs to meet production goals and objectives.
• Update manufacturing training materials.
• Work on the manufacturing floor for data gathering and observing of processes.
• May author and own investigation reports, change controls, and CAPAs related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering. Assign and implement proper corrective action and preventive action (CAPA) to resolve, and prevent recurrence of events.
• Conflict resolution, problem solving in a cross functional setting, and ability to meet production timelines.
• Remain current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs.
• May manage multiple projects and timelines concurrently.
• Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records, change controls, training documentations, protocols and white papers.
• 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.
• Prior experience as production scheduler in a manufacturing environment is required.
• Experience with scheduling tools that could be used for real time updates to production schedule is required.
• Manufacturing, specifically upstream and downstream processing, in a GMP environment is preferred.
• Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
• 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 a 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 manufacturing schedule as required.
• Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.
• Six Sigma Yellow, Green or Black Belt certification is preferred.

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.