Senior Stability Specialist

Job description

**Monday-Friday- 1st shift position (8am-5pm)

**Great promotion opportunity as a subject manner expert as a Stability Specialist**

Job Overview:

Executes stability programs to support product expiration dating, storage and handling, shipping and patient use in compliance with industry practices and regulatory requirements.  Also participates in the Periodic Product Review (PPR) process. 

Responsibilities:

·  Participate in monitoring stability storage conditions, submit stability samples to analytical laboratories when required and monitor laboratory test results.
·  Develop stability study protocols and establish strategies for stability studies.
·  Perform analysis of stability data and draft stability technical reports.
·  Escalate unusual observations, deviations or any incidence of non-compliance with established protocols or procedures.
·  Compile stability data for inclusion in regulatory submissions.
·  Participate in the compilation of Periodic Product Review (PPR) reports.
·  Participate directly with external departments (e.g. Manufacturing Science & Technology, External Supply Quality Assurance, and CMOs).

Requirements & Qualifications

·  Bachelor’s degree or equivalent and 2 - 4 years of experience.
·  Master’s degree or equivalent and 0 - 2 years of experience.
·  Quality Control/Assurance, Stability and GMP experience preferred.

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.

#GD-SG

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.