Senior Batch Release Specialist

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Sep 29, 2019
Ref
2019-3921
Hotbed
Bio NC
Required Education
Bachelors 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 Senior Batch Release Specialist will provide critical quality expertise to transition a novel gene therapy into commercially approved products. The Batch Release Specialist is responsible for; making quality decisions and addressing or resolving issues based on experience, written procedures and analytical analysis, supporting the batch issuance and batch release processes, and serving as the team lead for all activities related to initiation, collection, review, and approval of media/buffer, upstream, downstream, and fill/finish manufacturing documentation in support of the North Carolina manufacturing site.

Responsibilities

  • Qualified to perform all functions of Batch Release Specialist.
  • Responsible for ensuring the compliance of the manufacturing and packaging process documentation to cGMP, company policies and procedures; author/update SOPs, FORMS, etc. in documentation management system.
  • Responsible for the ERP release of intermediate, final product material and clinical/ commercial packaging both internally and externally for the site. This includes final documentation assembly, change control review, and the preparation of Certificates of Conformance.
  • Responsible for the review and approval of manufacturing batch records for all process streams.
  • Certified Trainer for all Batch Disposition activities and roles.
  • Perform mathematical calculations, including but not limited to: Adds and subtracts, divides units of measures using whole numbers, common fractions and decimals, and percentage, volume weights, and elapsed time.
  • Partners with other functional business units to resolve documentation and batch related issues.
  • Communicate batch review status and issues effectively and promptly.
  • Assist with the build and maintenance of the team SharePoint site; create charts and provide tracking for key metric related batch record documentation.
  • Support additional quality systems including, but not limited to, lot number issuance, batch disposition status changes, document management, non-conformances, change control and audits.


Qualifications

  • 5+ years of experience in Batch Disposition and/or Quality Assurance in a GMP environment including direct experience in documentation review.
  • Must have experience in batch disposition processes.
  • Experience with viral gene therapies and/or orphan disease indications is a plus.
  • Excellent oral and written communication skills.
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward; ideal applicant will be required to demonstrate high attention to detail, multi-tasking, and organization ability.
  • Proficiency in and knowledge of Microsoft Office, deviation and CAPA management software, and document management systems.
  • Must have a strong knowledge and application of the CFR's and cGMP's.

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.