• Senior Manager, Quality Lean Lab

    Job Locations US-CO-Longmont
    Posted Date 1 day ago(4/17/2019 10:37 AM)
    Job ID
    2019-3317
    # of Openings
    1
    Category
    Quality
  • 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 Senior Manager will play a critical role in helping QC nurture a culture of continuous improvement by implementing Lean Laboratory management systems and approaches. This person will help Identify and implement continuous improvement activities within the QC laboratories. The Senior Manager will coordinate activities relating to continuous improvement and enhance knowledge of the tools and techniques of continuous improvement / Lean methodologies. 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 Senior Manager 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. 

    Responsibilities

    • Identifies and implements continuous improvement activities in the QC laboratories. Improvement projects include, but are not limited to cycle time improvement, consumable use reduction, cost reduction, variation reduction, constraint improvement, non-conformance reduction.
    • 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.
    • Assist with manufacturing projects, from the initial scoping and chartering stage through project close-out with benefits realization.
    • Train laboratory staff on various operational excellence tools.
    • Encourages a Lean culture by influencing and empowering employees to identify opportunities to apply techniques and tools in everyday work activities.
    • Facilitate sharing of best practices and project successes across the organization.
    • Works on projects both individually and cross functionally.
    • Management of multiple projects and timelines concurrently.
    • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines.
    • Support strategic proposals, progress updates and presentations to all levels of the site organization.
    • Support implementation of Lean Laboratory principles throughout the AveXis network.

    Qualifications

    • Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience.
    • Minimum of 6 years of practical experience with Lean methods / continuous improvement in a GMP 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.
    • Strong working knowledge of QC laboratory processes and instruments in a GMP environment.
    • 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.

    #LI-RM1

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed