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Stability Specialist

Westborough, Massachusetts

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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Rewards

  • HEALTH AND WELLNESS PROGRAMS

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • EMPLOYER MATCHING

    Employer matching because Sanofi invests in their employees!

  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

**Monday-Friday- 1st shift with flexibility on start and end time

**High-paced desk environment with movement within the building

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.
  • Participate in developing stability study protocols and in in establishing 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 and Qualifications:

  • Bachelor’s degree and 1-3 year’s experience. 

    Preferred Qualifications:

  • Quality Control and/or Stability and GMP Experience.
  • Ability to work independently in a fast-paced environment.
  • Strong organizational skills and high attention to detail. 

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

#LI-GZ 

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.

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