Batch Release Senior Specialist - Gene Therapy Quality Assurance

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Oct 01, 2019
Ref
2019-4263
Hotbed
Bio NC
Required Education
Associate Degree
Position Type
Full time
Overview

Ready 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.

The Batch Release Senior Specialist level position reviews and releases all production intermediates from Cell Expansion through to Drug Substance. They handle the authoring of area SOPs/FORMs and serve as the team SME and trainer of all functions under their role and below. The Senior Specialist is the SME and certified trainer for all area processes.

Responsibilities

  • Responsible for the ERP release of downstream TFF3 buffer and Drug Substance process material.
  • Author and provide GDP expertise for MBR design.
  • Functions as certified trainer for Document Processor, Associate and Specialist I roles.
  • Performs production Lot Number assignment.
  • Support additional quality systems including audits.


Qualifications

  • 5+ years of experience in Batch Disposition and/or Quality Assurance in a GMP environment.
  • Must have comprehension of AveXis batch disposition processes.


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.