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Job Title: Quality Control Scientist

Location: Waltham, MA

About the Job

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.

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 new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

The Quality Control (QC) Scientist within mRNA Center of Excellence (mRNA CoE) will be responsible for hands-on operations, compliance support as well as supervising and managing different activities within the QC laboratory activities supporting mRNA vaccine development in the QC laboratory.

The QC Scientist will support both internally QC Lab within Sanofi US site and externally at Contract Testing Laboratories (CTL) for various QC and analytical activities.

The QC Scientist will support with both GMP and GLP activities across different projects within mRNA CoE.

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!

Main Responsibilities:

• Development, qualification and/or validation of methods for Drug Substance and Drug Product testing to be implemented in QC Lab

• Perform release, stability testing and in-process testing of GMP and non-GMP batches

• Support Raw material method development, qualification, and/or validation of methods for Raw material testing.

• Planning, initiation, execution and tracking of projects and activities

• Provide leadership and guidance to younger members of the team to ensure successful daily operation. 

• Review testing results for content and compliance

• Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory. 

• Execute routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE and others.

• Executes routine procedures based on bioassay methodologies, such as plate based assays (ELISA, ddPCR, ribogreen, others), gel electrophoresis, western blot and cell based assays and others.  

• Authors revisions to SOPs for managerial review and approval. 

• Executes troubleshooting with minimal guidance from supervisor or senior team members. 

• Acts as trainer for specific methodology, responsible for training less experienced analysts on assays of expertise. 

• Participate in continuous improvement of laboratory safety and quality compliance.

• Support cGMP operations of the QC Laboratory and support team schedules as requested.

• Support on monitoring QC product release and stability testing, to 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.

• Draft, 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.

• Provide support to ensure successful daily operation. 

• Train and supervise QC Analytical team members as requested.

• 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 cross-functional teams as well as external partnerts as needed.

About You

• Earned Bachelor degree in a scientifically relevant field with 8+ years of experience in Quality Control, OR

  Earned Master degree in a scientifically relevant field with 5+ years of experience in Quality Control, OR

  Earned PhD in a scientifically relevant field with 3+ years of experience in Quality Control

• 8+ years of experience working within a lab environment, including experience troubleshooting issues and maintaining inventory

• Ability to draft, review and implement SOPs, tech transfer, qualification, and validation protocols.

• Prior leadership, mentorship or training experience within a lab environment is highly preferred

• Strong commitment to collaborative work within a team, including strong verbal and written communication with all stakeholders

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 and wellness 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 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.