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mRNA Center of Excellence Quality Control Senior Scientist

AT Sanofi U.S.
Sanofi U.S.

mRNA Center of Excellence Quality Control Senior Scientist

Gunnison, CO

About the job

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.

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That's why we're looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We're investing €400m a year into the Center, focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!

About the Opportunity

The Quality Control Supervisor within mRNA Center of Excellence will be responsible for overseeing operations within the QC laboratory activities supporting mRNA vaccine development in the Analytical Development quality control laboratory.
  • Provide leadership and guidance to team to ensure successful daily operation, including the supervision of cGMP operations and creating team schedules.
  • Supervise QC product release and stability testing, ensure timely completion of testing.
  • Initiate and own, execute and support laboratory deviations, laboratory errors, OOS/OOT investigations.
  • Propose effective CAPAs for investigations and deviations.
  • Oversee in-process, release and stability testing, and review and approve data.
  • Implement new technologies and quality procedures.
  • Develop, review and implement SOPs, tech transfer, qualification, and validation protocols.
  • Ensure regular maintenance of complex laboratory equipment.
  • Review QC data and reports for compliance to procedures and specifications.
  • Ensure QC laboratory instruments IQ/OP/PQ completed before cGMP testing.
  • Train and supervise QC Analytical team members.
  • Ensure execution of laboratory activities in strict accordance with standard operating procedures and cGMP.
  • Escalate laboratory issues related to personnel, procedures, materials, process, equipment, or information systems to senior management and/or appropriate functional area(s).
  • Interact with project teams, analytical development, and process team for product GMP testing needs.

About You

  • Earned Bachelor degree or Master degree with 8+ years of experience in Quality Control or PhD with 3+ years of experience in Quality Control.
  • 3+ years of supervising/managing analytical laboratories and applying GMP in QC labs

  • 3+ years of experience with some of the techniques including UPLC/HPLC, SoloVPE, Ribogreen, cell culture, ELISA, and/or PCR, etc.
  • Industry knowledge of quality systems and regulatory requirements

  • Excellent communication skills


Why Choose Us
  • Bring the miracles of science to life alongside a supportive, future-focused team.
  • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks' gender-neutral parental leave.


Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicantswill receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domesticpartnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liabilityfor military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) orany other characteristic protected by law.

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Client-provided location(s): United States
Job ID: Sanofi-https://jobs.sanofi.com/en/job/waltham/mrna-center-of-excellence-quality-control-senior-scientist/2649/17271542464
Employment Type: Other