Production Support Associate Specialist

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Nov 30, 2018
Ref
2018-2755
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.

As part of the manufacturing organization, the Associate Specialist will 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 Associate Specialist will initiate, and drive change controls related to manufacturing operations. 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

  • Authoring of minor and major investigation reports related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering.
  • Initiate, own, and drive change controls related to manufacturing operations.
  • Technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOPs), batch records, change controls and white papers.
  • Review of product support documentation (e.g., batch records, process validation, work orders, production of log books).
  • Perform appropriate root-cause analysis for events utilizing investigation tools (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.
  • 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.
  • Management of multiple projects and timelines concurrently.
  • 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 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, change controls and CAPA
  • Support manufacturing and Quality to assist in the data collection from manufacturing and preparation of necessary documentation to support Annual Product Reviews.


Qualifications

  • Bachelor of Arts/Science or equivalent combination of education minimum 3 years of 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.
  • 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.
  • Proactive, action oriented with ability to adapt to a change.
  • Ability to identify and flag risks in a timely manner to keep deliverables on track.
  • Strong communication skills, both verbally and written.
  • Proven logic and decision-making abilities, critical thinking skills.
  • Must be able to accommodate manufacturing schedule as required.
  • 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.