Sanofi Group Quality Engineer Senior - Stability 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.
Establish strategies and study designs for stability programs of new products and significant process changes.
Support development, implementation and maintenance of department database platform and network LIMS system.
Escalate unusual observations, deviations or any incidence of non-compliance with established protocols or procedures and participate in investigations and CAPA to drive closure and minimize program impact.
Collaborate directly with other departments (e.g. Quality Control, Quality Assurance, MSAT, Manufacturing, Regulatory Affairs and Science) and external CMO/CLO employees to address problems identified during stability studies.
Perform and review analysis of stability data and stability technical reports.
Support internal departmental audits and assist in the development of responses to observations and the completion of related CAPA.
Lead, develop and train less experienced employees, and develop and adapt training materials for effective knowledge transfer.
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 7 years (Bachelor) or 5 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.