- Communication Skills
- Laboratory Experience
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 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 3rd 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.
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.
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.