Sanofi Group Stability Specialist Principal in Northborough, Massachusetts
- Executes stability program to support product expiration dating, storage and handling, shipping and patient use in compliance with industry practices and regulatory requirements. Also participates in Product Quality Review process.
Oversee monitoring of stability storage conditions, stability samples and status of laboratory test results ensuring stability programs’ progress according to the established protocols.
Develop stability study protocols and establish strategies for stability studies of new products.
Submit stability samples to analytical laboratories when required.
Escalate unusual observations, deviations or any incidence of non-compliance with established protocols or procedures.
Participate directly with external departments (e.g. Science, Manufacturing and Quality Control) to address problems identified during stability studies.
Perform and review analysis of stability data and author stability technical reports.
Interpret complex, explicit documentation for new and current compliance procedures.
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.
Represent the department on project teams; ensure the department is included in decision-making and resolution of critical issues.
Participate in CTD section development for new and supplemental applications, as well as responses to regulatory agencies, as needed.
Bachelor or Master degree in a scientific discipline
Minimum of 6 years (Bachelor) or 4 years (Master) experience in the pharmaceutical/ biotechnology industry
Demonstrated knowledge of cGXP regulations and guidance
Ability to work independently
Strong technical writing skills
Quality Control and/or Stability 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.