Job Description Summary
The Senior Expert, Stability manages the planning, sampling, execution and data management of cell and gene therapy clinical program stability studies.
Job Description
Key Responsibilities:
Participates in Stability strategy and protocol design for cell and gene therapy clinical products
Oversight and coordination with internal partners or Contract Development & Manfacturing 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 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.
The pay range for this position at commencement of employment is expected to be between $118,400 and 177,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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.
Salary Range
$118,400.00 - $177,600.00
Skills Desired
Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Managing Resources, Organizational Savvy, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Smart Risk Taking, Technological Expertise, Total Quality Management