Sanofi Group Stability Specialist Principal in Northborough, Massachusetts
**Travel between Westborough, Northborough, and Framingham, MA campuses
**Monday-Friday- 1st day shift (With start/end flexibility)
**Stability experience preferred
Designs and executes stability programs to support product expiration dating, storage and handling, shipping and patient use in compliance with industry practices and regulatory requirements.
Monitor stability sample storage, submit samples to analytical laboratories and monitor test results.
Develop stability study protocols and establish strategies for stability studies.
Perform analysis of stability data and author stability technical reports.
Escalate unusual observations, deviations or any incidence of non-compliance with established protocols or procedures.
Participate directly with external departments (e.g. Manufacturing, Quality Control and Assurance) to address and correct problems identified during stability studies.
Represents the department on project teams; ensure the department is included in decision-making and resolution of critical issues
Compare regulatory agency enforcement action/trends to our current procedures and stability programs and identify potential problem areas.
Execute strategies and procedures on new assignments.
Lead, develop and train less experienced employees.
Requirements & Qualifications:
Bachelor’s degree (preferably in life science) or equivalent and 6 + years of experience.
Master’s degree (preferably in life science) or equivalent and 4 + years of experience.
Quality Control, Stability, and GMP experience.
Experience using statistical software packages and linear regression analysis.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life