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mRNA Analytical Development Senior Scientist for Quality Technical Support - Vaccine

Waltham, Massachusetts

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Overview

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"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."

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Responsibilities

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

At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. 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 for more people faster than before.

That’s why we’re looking for bold, optimistic world-changers to join the team at our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism for the future to Sanofi. Join us

About the Opportunity

In order to strengthen the R&D Analytical Sciences Department, Sanofi Pasteur is looking for a skilled and highly motivated individual to join the analytical development department to support the quality control activities for mRNA vaccines development.

Analytical Sciences Department has the overall responsibility to develop, qualify and validate robust analytical methods, and provide testing to support release and characterization of mRNA Drug Substances and Drug Products candidates in development.

In this role you will be responsible for, not limited, to the following core responsibilities

  • Participate QC OOS and laboratory investigations, support deviations and change controls by working with internal AD and QC teams and CRO labs.  

  • Monitor analytical methods performance and trend method robustness data from early to late phase.

  • Work with the internal analytical development teams and CRO to perform analytical methods improvement and optimization based on QC performance feedback.  Lead method assessment, gap analysis, and risk assessment.

  • Develop and author complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.

  • Act as a study director, coordinating with the bioassay and biochemistry groups, design and execute analytical method qualification and validation studies for mRNA DS and DP methods.

  • Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process. 

  • Contribute to the understanding and interpretation of results and how they impact the design of subsequent experiments. 

  • Ensure timely completion of assignments and deliverables. Independently design and execute complex experiments.  Author method development and investigation reports.

  • Participate internal GMP lab set up, lead QC instrument IQ/OQ/PQ and instrument maintenance for the QC lab.

  • Lead work of analysts and junior scientists.  

Relevant qualifications & capabilities

  • Degree in Analytical Chemistry, Biology, Biochemistry or related sciences

  • Bachelor’s degree or equivalent and 12+ years of experience.

  • Master’s degree or equivalent and 8+ years of experience.

  • PhD or equivalent and 4+ years of experience.

  • Expert technical expertise in one or more platforms.

  • Strong written and verbal communication skills.

  • GMP experience

  • Experience in biochemical biophysical and bioassay including but not limited to method of UV, Fluorescence, chromatography (RP HPLC + SEC), LC-MS, sanger sequencing, high throughput sequencing, ELISA, qPCR, ddPCR, FTIR, Raman, etc.

  • Knowledge of nucleic acid/oligonucleotides chemistry and standard analytical methods of these molecules

  • Experienced working with highly technical projects with reactivity

  • Excellent verbal and written communication skills

  • Able to work independently and collaborate in team, enthusiastic and self-motivated

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.

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.

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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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