Manager, Process Investigations and Continuous Improvement

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Sep 07, 2018
Ref
2018-2443
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. 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 successful candidate will be an internal consultant to the manufacturing organization and have responsibility for building and leading the group that will be responsible for documentation of 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. Manager, Process Investigations and Continuous Improvement 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, formulation, filling, inspection, packaging, facilities and engineering.
  • Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.
  • Review of product support documentation (e.g., batch records, process validation, work orders, production of log books).
  • 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.
  • Act as liaison with the Technical Quality of Operations Department for the acceptability and timeliness of reports.
  • 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 Notice of Events, 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.
  • Develop team etc. to become Subject Matter Experts in assigned areas.
  • 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.


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.


This position will be located out of our Libertyville office.

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.