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mRNA CoE Analytical Development Quality Control Supervisor Analytical Sciences - Vaccines

Sanofi

Sanofi

People & HR, Operations, Quality Assurance
Waltham, MA, USA
Posted on Thursday, May 4, 2023

mRNA CoE Analytical Development Quality Control Supervisor Analytical Sciences - Vaccines

Waltham, Massachusetts

Overview

From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.

Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Results-driven
  • Proactive
  • Problem-Solver
  • Leadership
  • Team player

Culture: Play to Win

  • Growth

  • Innovation

  • Efficiency

  • Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

Quote

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

In the race for the future of health – The Sanofi mRNA Center of Excellence (CoE)

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.

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!

Intro About the Position

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.

Key Responsibilities for Position

About growing with us for winning with us

In this role you will….

Responsibilities of the QC Supervisor of AD-QC Laboratory:

  • Provide leadership and guidance to team to ensure successful daily operation.

  • Supervise cGMP operations of the QC Laboratory and create and update 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 at the QC lab.

  • 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.

  • Provide leadership and guidance to team to ensure successful daily operation.

    • 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.

Competencies / Requirements for Position

Requirements of the QC Supervisor:

  • Bachelor’s degree with 8+ or Master's degree with 5+ years of experience in QC Analytics

  • 1+ years of supervising/managing analytical laboratories and applying GMP in QC labs

  • 3+ years of experience with some of the techniques including CGE, CE, UPLC, GC-FID, cell culture, ELISA, and/or qPCR, etc.

  • Industry knowledge of quality systems and regulatory requirements such as 21 CRF Part 11/210/211

  • Excellent communication skills

  • Must be eligible to work in the US

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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