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Sanofi Group Senior Scientist - LC-MS in Waltham, Massachusetts

Overview:

Sanofi is seeking an accomplished analytical research and development scientist to join the Chemical/Biochemical Fingerprinting & Advanced Analytics group currently located in Waltham MA. This position will be moving to Cambridge, Massachusetts, by the end of 2022. The group belongs to a larger Analytics group, which, combined with Synthesis Development, Biopharmacy and Early Formulation Development, constitutes the Early Development organization in the US (EDUS) providing the CMC expertise to advance projects from late-stage research through early clinical development up to Phase 2 clinical trials. As part of the Global CMC Development organization, EDUS is striving to become an industry leader in the development of transformative medicines.

Reporting to the Scientific Director of Analytics, the Senior Scientist is expected to be a major contributor in establishment and implementation of advanced attribute monitoring approach by applying chemical and biochemical fingerprinting techniques such as global profiling by LC-High Resolution Mass Spectrometry and Quantitative LC-MS/MS. Work entails a balance of method development and analytical support of the Synthetics organization at Global CMC, as well as supporting in vivo and in vitro studies, manufacturing troubleshooting and biologics when advanced analytical fingerprinting support is needed. Collaborative projects involve development and transfer of analytical methods to collaborating Sanofi groups in the US and Globally.

Key Responsibilities:

  • Serve as a major contributor in establishment of analytical and digital tools for streamlined identification of pharmaceutical impurities and degradants, assisting chemists with selection of the optimal synthesis route and raw materials using advanced analytics and in silico prediction approach.

  • Collaborating with external and internal partners participate in establishment of in-house data bases for identification of different classes of unknowns, including impurities, degradants, complex synthetic and biological materials, and biomarkers.

  • Develop and implement analytical methods for global LC-High Resolution MS analysis and targeted LC-MS/MS analysis in both conventional and high throughput formats.

  • Provide scientific guidance to a contractor/managed worker involved with the LC-MS analyses.

  • Collaborate closely with Process Chemistry and Process Engineering on establishment and implementation of advanced tools for characterization and stability of research compounds and early development drug candidates

  • Interact and collaborate closely with formulation development, biopharmacy, synthesis development, medicinal chemistry and process chemistry and process engineering groups, as well as in vitro biology, pharmacology, DMPK and toxicology to support pre-development and early development activities up to Phase 2 clinical trials when projects transition to late development

  • Responsible for the proper maintenance and operation of the analytical equipment in the laboratories, interact closely with the vendors of major LC-MS equipment to assure that

  • Promote compliance on Health, Safety and Environment in the analytical laboratories

Basic Qualifications

  • PhD in Pharmaceutical Analytical Chemistry or related sciences, with a minimum of 4 years of related experience or a Master's degree with a minimum of 8 years or related experience

  • Demonstrated expertise with development and qualification of LC-High Resolution MS and LC-MS/MS methods for global profiling and targeted quantitative assays.

  • Experience with constructing and using databases for unknown identification

  • Proficiency with using advanced software for processing of multi-attribute LC-MS data.

  • Experience with statistical analysis of multi-attribute data

  • Experience in broad range of sample preparation techniques and chromatographic separation

  • Experience with global profiling applications such as metabolomics and lipidomics is particularly relevant.

  • Experience operating, tuning, calibrating and verifying performance of LC-High resolution MS systems (Acquity UPLC, Vanquish, Transcend LX4 Multiplex, as well as QExactive Orbitrap and Triple quadrupole mass spectrometers)

  • Expertise with the study and identification of chemical process impurities and degradation products

  • Computer literacy with proficiency in Microsoft Office software, electronic notebook documentation and LIMS

  • Excellent interpersonal relationship skills and strong oral/written communication abilities along with demonstrated good documentation practices.

  • Experience in working with cross-functional teams

  • Ability to serve as an analytical representative on the cross-functional project team

Preferred Qualifications

  • Experience with development of LC-MS methods with various reverse phase and HILIC front end separations

  • Expertise in detecting and addressing matrix effects in LC-MS analysis

  • Experience of working with complex synthetic materials and with biological samples

  • Expertise in qualification of analytical methods, preparation of protocols and method transfer

  • Basic script writing skills is a plus

  • Experience with GC-MS and ICP-MS and spectroscopic techniques

  • Ability to handle and prioritize multiple assignments

  • Strategic and innovative thinker with a track record of fresh insightful thinking by developing creative approaches to solve complex analytical challenges in a timely manner

  • Experience in providing analytical expertise to Process Chemistry / Process Development teams for impurity identification and tracking

  • Experience in regulatory submission is a plus.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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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