Manager, Process Investigations and Continuous Improvement
Company: AveXis Inc.
Posted on: June 15, 2019
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
- 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
- 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
- Management of multiple projects and timelines
- 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
- Conduct personnel interviews and system reviews. Act as an
unbiased investigator with questions surrounding the specific
- 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
- Represent Process Investigations Team on the monthly Quality
Management Review meetings.
- Present investigations to regulatory agencies during
- Bachelor of Arts/Science or equivalent combination of education
- 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
- Must have proven logic and decision-making abilities, critical
- 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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