Production Support Associate Specialist - Change Control/ Projects

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Jan 23, 2019
Ref
2019-2942
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 Production Support Group is a part of the manufacturing organization and is responsible for projects, change controls, investigations into non-conformances, CAPAs, continuous improvement projects, internal training and scheduling, and batch record/SOP authorship. The Associate Specialist will be responsible for initiating, driving, and tracking change controls related to manufacturing operations. The Associate Specialist will also be responsible for managing projects and owning the manufacturing project dashboard. Additionally, the successful candidate may be responsible for the investigation and completion of non-conformances aimed at identification of root cause, assessing potential impact as well as implementation of corrective actions and preventive actions. The successful candidate will work in a cGMP environment and must have working knowledge of biopharmaceutical manufacturing processes, 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 while performing investigations. Must have the ability to understand and 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

  • Initiate, own, and drive change controls related to manufacturing operations, including but not limited to, cell culture, purification, formulation, filling, inspection, and packaging.
  • Follow up on outstanding change controls that have been requested to make sure they get closed out.
  • Follow up with change control owners to make sure all new change controls are completed on time.
  • Track KPI's tied to Change Management and provide updates to management on routine basis.
  • Perform manufacturing documents changes as required by change controls.
  • Technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records, change controls, training documentations, and protocols.
  • Responsible for managing projects tied to Change Controls and attending necessary meetings as required to provide input.
  • Management of multiple projects and timelines concurrently.
  • Own manufacturing project dashboard and be single of contact for tracking manufacturing projects.
  • Set deadlines, assign responsibilities and monitor and summarize progress of projects.
  • Develop a detailed project plan to monitor and track progress.
  • May author investigation reports related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering.
  • Work on the manufacturing floor for data gathering, observing of processes for investigations, and interviewing employees. Assign and implement proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
  • May perform appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams).
  • Facilitate and participate in meetings, 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.
  • Remain current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs.
  • Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Support manufacturing and Quality to assist in the data collection from manufacturing and preparation of necessary documentation to support Annual Product Reviews.
  • Review of product support documentation (e.g., batch records, process validation, work orders, production of log books).


Qualifications

  • Bachelor of Arts/Science or equivalent combination of education with minimum relevant experience.
  • Prior experience in managing change controls and projects in a manufacturing environment preferred.
  • Manufacturing, 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 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 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.