Senior Specialist, Global Stability Quality Control

Longmont, CO, US
Nov 26, 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 Senior Specialist, Global Stability Quality Control, Manages the planning, sampling, execution and data management of program stability studies.

  • Participates in Stability strategy and protocol design.
  • Writes technical reports; technical report generation (Expiry, Result Record, and APQR).
  • Data management to support the Stability Programs including the administration and distribution of QC stability samples, associated document coordination, and collection and evaluation of data.
  • Serves as the subject matter expert (SME) for stability program related functions.
  • Owner of stability work processes supporting the stability programs.
  • Participates in study design and ensures scheduling of stability lots.
  • Tracks stability time points and evaluates stability data on a routine basis.
  • Document owner for procedures and work instructions in support of stability processes.
  • Owner and assessor of out of trend (OOT) and out of specification (OOS) events.
  • Owner, assessor, and/or reviewer of deviations, change controls, and lab investigations.
  • May generate metrics for stability programs.
  • Reports risks related to stability programs to Quality System Owner(s).
  • Other related job duties as assigned.

  • Bachelors' and/or Masters' Degree in scientific discipline with a technical understanding of biopharmaceutical or Gene therapy production (gene and/or cell therapy development and manufacturing experience advantageous).
  • 5 years of GMP QC/QA lab experience.
  • 4 years of experience in Stability is preferred.
  • Knowledge of Biologics and/or Gene therapy testing methods, validation and qualification.
  • Knowledge of ICH, specifically stability guidelines.
  • Excellent oral and written communication skills with technical writing experience.
  • Expertise in use of MS suite of programs (outlook, excel, powerpoint, word, etc).
  • Ability to work independently, collaboratively, and effectively. Problem-solving aptitude with ability to prioritize and deliver on tight timelines.
  • Understanding of LIMS systems (StarLIMS beneficial): SQL query, language, XML, visual basic, and data generation flow to reporting is beneficial.
  • Experienced quality professional with knowledge of the drug development and quality control process and associated methods.

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. #LI-MG1