Quality Control Stability Coordinator

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.

The Stability Coordinator will coordinate all work processes associated with the Product Stability Programs at AveXis Inc including organizing the Stability Study Design and ensuring test scheduling is executed in-house or at 3 rd party contract laboratories according to the respective stability protocols. The QC Stability Coordinator may act as a delegate for the Manager during regulatory inspections and be a document author for studies and procedures in support of the Product Stability and Sample Management Programs. Key accountabilities include, but are not limited to program management, data organization, technical writing, metrics, and investigations.

A potential candidate will possess a strong understanding of Stability Testing requirements per ICH guidelines and FDA/EMEA regulations and ensure adherence to all GMP requirements. This position will also support the QC Department for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.

Responsibilities

• Coordinates work processes associated with the AveXis Stability programs.
• Develops the Stability Study Design and ensures scheduling and testing of stability lots.
• Manages all stability studies through execution of the following:
  • Authors protocols and reports;
  • Data entry and review;
  • Provides Quality representation on Product Working Teams for change controls, deviationsand
• Conducts Data analysis and authors trending reports.
• Supports subject matter expert for applicable studies during regulatory inspections.
• Serves as document author for procedures and work instructions in support of the Stability and Sample Management programs.
• Generates process related metrics, monitoring for efficiency.
• Generates metrics for stability and sample management programs.
• Provides stability data for regulatory filings.
• Provides stability summaries for annual product review.
• Authors Change Controls and assesses stability impact on proposed changes.

Qualifications

• Bachelor's Degree in Chemistry, Biology or related sciences
• Minimum of 5 years of relevant experience in a pharmaceutical testing laboratory
• Experience and understanding of ICH stability guidelines.
• Prior experience with QC Stability and Sample Management and LIMS
• Expertise in use of Excel or comparable software solutions for management and analysis of data
• Strong problem-solving abilities
• Ability to work independently and effectively
• Ability to prioritize and deliver on tight timelines
• Demonstrated ability to work in a collaborative environment with positive interactions and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building
• Good critical thinking, deductive reasoning, and decision-making skills
• Ability to work effectively within the site and across 3rd party testing laboratories.
• Proven effective communication skills

Approximately 10% travel required.

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.