Manufacturing Operational Excellence- Gene Therapy

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Feb 26, 2019
Ref
2019-3070
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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 Specialist will play a critical role in helping manufacturing nurture a culture of continuous improvement by implementing Lean management systems and approaches. This person will help Identify and implement continuous improvement activities on the manufacturing floor. The Specialist will coordinate activities relating to continuous improvement and enhance knowledge of the tools and techniques of continuous improvement / Lean methods. The successful candidate will work in a cGMP environment and must have 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 Production Support Specialist must have the ability to problem solve in an environment that is focused heavily on Chemical and Biological issues. 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

  • Identifies and implements continuous improvement activities on the manufacturing floor. Improvement projects include, but are not limited to cycle time improvement, scrap rate reduction, cost reduction, variation reduction, constraint improvement, non-conformance reduction.
  • Supports the overall continuous improvement program for the entire manufacturing process. Provides coordination of activities relating to continuous improvement and enhancing knowledge of the tools and techniques of continuous improvement / Lean methods.
  • Identifies, plans and assists with the execution of various continuous improvement projects targeted towards improving the business performance related to quality, productivity, safety, compliance and cost.
  • Understand deviations from the production plan and budget and work with site leaders to identify corrective actions using appropriate continuous improvement tools (e.g. kaizen, 5S, gemba, six sigma, LEAN).
  • Assist with manufacturing projects, from the initial scoping and chartering stage through project close-out with benefits realization.
  • Train manufacturing teams on various operating excellence tools.
  • Works on projects both individually and cross functionally.
  • Management of multiple projects and timelines concurrently.
  • Present on the manufacturing floor for data gathering and observing of processes to identify areas for continuous improvements.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines.
  • Support the Production Support Group in other activities, as needed (e.g. driving projects, performing investigations, owning change records).
  • 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.
  • Minimum of 3 years of practical experience with Lean methods / continuous improvement in a manufacturing environment
  • Proficient facilitator of workshops and process improvement initiatives using continuous improvement methodologies.
  • Ability to quickly understand details, determine interdependencies and develop operationally practical and efficient solutions.
  • Experience/Knowledge in the OE/CI best practice methodologies, e.g. principles of Six Sigma, Lean Manufacturing, KPI development, RCA.
  • Must have one of the following: Six Sigma Black Belt, Green Belt, Yellow Belt or formal Six Sigma training.
  • Manufacturing experience, 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 adaptable to 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.


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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