Senior Expert Stability

Job Description SummaryThe Senior Expert, Stability manages the planning, sampling, execution, and data management of cell and gene therapy clinical program stability studies.Job DescriptionKey Responsibilities:Participates in Stability strategy and protocol design for cell and gene therapy clinical products.Oversight and coordination with internal partners or Contract Development & Manufacturing Organization (CDMO)/Contract Manufacturing Organization (CMO) for stability program management.Writes technical reports; technical report generation (Expiry, Result Record, Investigations).Data management to support the Stability Programs including the administration and distribution of Quality Control (QC) stability samples, associated document coordination, and collection and evaluation of data.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 and may generate metrics for stability programs. May also report risks related to stability programs to Quality System Owner(s).Essential Requirements: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).Minimum of 5 years of Good Manufacturing Practice QC/QA lab experience. Experience in Stability is highly 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, with expertise in the 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 Lab Information Management Systems (LIMS), database query, and data generation flow to reporting and visualization is beneficial.Experienced quality professional with knowledge of the drug development and quality control process and associated methods.Salary Range:

$118,400 - $177,600/year.Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?Commitment to Diversity & Inclusion:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.Accessibility and Reasonable Accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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