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Manager, Process Investigations and Continuous Improvement

Company: AveXis Inc.
Location: Longmont
Posted on: June 15, 2019

Job Description:

OverviewReady 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. Responsibile for building and leading the group that will be perform and document investigations, deviations, non-conformances, CAPAs, and continuous improvement plans. The Process Investigations and Continuous Improvement Group is responsible for the initiation, investigation and completion of non-conformances aimed at identification of root cause, and implementation of corrective actions and preventive actions. The candidate works in a cGMP environment and must have working knowledge of biopharmaceutical manufacturing processes, the ability to manage multiple ongoing projects concurrently, excellent leadership and supervisory abilities, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while ensuring completion of investigations. The Manager must have the ability to understand and problem solve in an environment that is focused heavily on Chemical and Biological issues. This person needs to understand the concepts incorporated in Quality Assurance in a GMP environment. Skills in statistics are required to effectively analyze trends.Responsibilities

  • Authoring/Owning/Ensuring investigations related to cell culture, purification, facilities and engineering.
  • Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.
  • Perform/Review appropriate root-cause analysis for events utilizing investigation tool (e.g., 5 whys, Fishbone Diagrams).
  • Assign proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
  • Utilize appropriate risk management tools for recommendation on disposition of materials.
  • Present completed investigations for final approval.
  • Performance of risk assessments.
  • Meeting facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.
  • Management of multiple projects and timelines concurrently.
  • Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Work on the manufacturing floor for data gathering, observing of processes for investigations, and interviewing AveXis employees.
  • Conduct personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue.
  • Remain current in regulatory expectations and industry practices regarding investigations and CAPA.
  • Track, trend and facilitate all manufacturing related deviations, investigations and CAPAs.
  • Support manufacturing and Quality to assist in the data collection from manufacturing and preparation of necessary documentation to support Annual Product Reviews.
  • Manage team workload/delegate as necessary.
  • Drive continuous process improvement of manufacturing processes, investigation processes, etc.
  • Hire key investigations personnel.
  • Provide direct technical/managerial leadership to Process Investigations group.
  • Represent Process Investigations Team on the monthly Quality Management Review meetings.
  • Present investigations to regulatory agencies during inspections. Qualifications
    • Bachelor of Arts/Science or equivalent combination of education minimum.
    • 5+ years' relevant experience.
    • Manufacturing, specifically upstream and downstream processing in a GMP environment is preferred.
    • Prior experience in quality investigations and deviation writing in a manufacturing environment required.
    • 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 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-RL1

Keywords: AveXis Inc., Denver , Manager, Process Investigations and Continuous Improvement, Executive , Longmont, Colorado

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