Specialist, Commercial Quality Control

Location
Durham, NC, US
Posted
Aug 19, 2020
Ref
5427
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 Specialist, Commercial Quality Control, collaborates closely with Analytical Development, Quality Control and other teams to manage and define the QC reference standard, method control and critical reagent program. Including inventory management, business continuity and material qualification/reassessment activities.

Responsibilities
  • Owns and authors commercial QC reference standard, method control and critical reagent program. Including inventory management, business continuity and material qualification/reassessment activities.
  • Owns, develops, authors and revises the QC global policy and multi-site SOPs.
  • Leads on-time investigation/closure of Quality records affecting multiple commercial QC sites (NCRs, CCRs, CAPAs).
  • Owner, assessor, developer, and/or maintains the QC Key Performance Indicators (e.g. on time testing, schedule adherence, invalid/OOS/OOE/OOT trending etc.); Generates metrics.
  • Interfaces with Global QC for new product introduction into QC Commercial; Networks with senior internal and external personnel in own area of expertise.
  • Writes/Authors and revises documents such as SOPs, Reference standard/controls qualification protocol and reports.
  • Leads investigations for deviations with multisite impact to determine root cause of deviations and non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
  • Other related duties as assigned.

Qualifications
  • Bachelor's degree in Chemistry, Biology or related scientific field and 5 years of industry experience or Associate's degree with 10 years equivalent experience.
  • 5 years in GMP Quality Control laboratory environment preferred.
  • Extensive knowledge of GMP, GLP and GDP principles.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Possess strong understanding of QC testing operations.
  • Understanding of QC assays, such as cell-based assays (e.g potency, ELISA, qPCR, and separation, virus infection, etc.) preferred.
  • Ability to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions; normally receives little instruction on day-to-day work, general instructions on new assignments.
  • Potential for up to 20% 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.