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Sanofi Group Quality Control Principal Analyst in Framingham, Massachusetts

Tuesday - Friday - 1st shift

Who You Are:

You are a highly skilled Quality Control Chemistry professional with experience running complex assays. You are passionate about working in a laboratory environment and enjoy helping other team members ensure success. You have a strong compliance mindset and a talent for troubleshooting assays and instrumentation.

The Team:

They are a diverse group and will be able to offer their own experiences and knowledge that others don’t possess. They communicate openly with each other, sharing their thoughts, opinions, and ideas. They offer each other support and are always happy to help others when they need a helping hand.

What we do:

QC Chemistry is responsible for testing intermediate, finished product, and stability samples in support of Framingham Manufacturing. Our state-of-the-art Integrated Continuous Biomanufacturing (ICB) Facility leads the way in delivering the next generation of biologics manufacturing.

Job Highlights:

The QC Principal Analyst is responsible for performing routine and complex techniques associated with daily QC release and provide in-depth investigative and technological orientation in implementing, executing, and interpreting quality procedures and test methods in a cGMP environment. The successful candidate will also contribute to process and method improvements within the Quality Control laboratory

Core Responsibilities:

  • Perform UV-Vis spectrophotometry assays, LCS, HPLC/GC/SDS-PAGE methods for in process and final product samples.

  • Utilize electronic systems (Bio-LIMS, Empower, OpenLab) for execution and documentation of testing

  • Review maintenance on complex laboratory equipment including HPLC and GC systems.

  • Review QC Data for compliance to procedures and specifications.

  • Contribute substantially to the interpretation of results and subsequent impact to product/methods.

  • Work effectively with others to achieve shared goals and meet timelines.

  • Work independently with minimal to no supervision and direction.

  • Practice safe work habits and adhere to Sanofi's safety procedures and guidelines.

Basic Qualifications:

  • Bachelor's Degree in Life Sciences discipline and 6 years experience in cGMP lab environment, or Master's Degree in Life Sciences discipline and 4 year experience in cGMP lab Environment.

  • Proficient in MS Office and lab-based data management systems.

  • Familiarity with USP and global compendial regulations.

  • Scientific technical writing ability including authoring and revising SOPs or technical reports.

  • Experience troubleshooting of assay and equipment issues.

Preferred Qualifications:

  • *At least 5 years experience with GC, HPLC, UPLC, Gel Electrophoresis, UV-Vis Spectroscopy and wet Chemistry.

  • Experience with Empower and Bio-LIMS software

  • Strong computer, verbal, and written communication skills

  • Knowledge of cGMP, ICH, USP, and global compendial regulations and guidance’s

  • Effective skills in time management, organization, teamwork and collaboration

Fine Print:

On site position in Framingham, Massachusetts.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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.

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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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