Quality Control Stability Coordinator

Longmont, CO, US
Sep 23, 2020
Required Education
Bachelors Degree
Position Type
Full time

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Stability Coordinator will coordinate all work processes associated with the Product Stability Programs at Novartis Gene Therapies 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 Novartis Gene Therapies 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.

Novartis Gene Therapies 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.