Quality Assurance Specialist (QA for QC)

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Oct 09, 2019
Ref
2019-4311
Hotbed
Bio NC
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 (ZOLGENSMA®). 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.

AveXis is seeking an experienced Quality Assurance professional to join our Quality Assurance (QA) for Quality Control (QC) team. The qualified individual will provide significant contributions as we continue to develop and maintain laboratory quality standards to ensure AveXis products are manufactured to relevant patient safety and product quality standards in line with business requirements.

Responsibilities

  • Provide QA oversite for the development, qualification, validation, and transfer of analytical methods.
  • Monitor routine method and equipment performance for trends and adherence to existing and new quality standards.
  • Interpret characterization, product release, and stability data.
  • Participate in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions.
  • QA representative for the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results. Support QC CAPAs and Change Controls.
  • Support invalid assay and aborted assay investigations.
  • Provides support to ensure successful accomplishment of business goals.
  • Perform other related duties as assigned.


Qualifications

  • Bachelor's Degree in a scientific discipline.
  • 5-7 years working experience in the Biotech/Pharmaceutical industry dependent upon level of education, with at least 5 years working directly with or supporting laboratory functions.
  • Strong knowledge of USP, ICH, and Ph Eur regulations as they relate to Quality Control.
  • Experience working with teams implementing lean processes into a GMP lab or manufacturing environment.
  • Outstanding problem-solving abilities.
  • Strong technical writing capabilities.
  • Ability to work independently and effectively.
  • Ability to prioritize and deliver on tight timelines.
  • Good critical thinking, deductive reasoning, and decision-making skills.
  • Approximately 10% travel.

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.