mRNA Quality Control Lab Manager at Sanofi in Waltham, Massachusetts

Job Description:

Job title: mRNA Quality Control Lab Manager



Location: Waltham, MA



About the Job



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!


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.


The 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.


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.



Main Responsibilities:

• Participate in 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.
  
  

About You

• Earned degree in Analytical Chemistry, Biology, Biochemistry or related sciences (Bachelor's degree and 8+ years of experience, Master's degree and 5+ years of experience, OR PhD and 2+ years of experience).
  
  


• GMP experience
  
  


• Technical experience in one or more biochemical biophysical and bioassay platforms 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. (HPLC most desirable)
  
  


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


• 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
  
  

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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