Principal Scientist, Analytics, Early Development, Synthetics Platform

Principal Scientist, Analytics, Early Development, Synthetics Platform, Cambridge Crossing, MAJob Overview:Sanofi is seeking an accomplished analytical research and development scientist to join the Analytics grou plocated in Cambridge Crossing, MA. The Analytics group combined with Synthesis Development, Biopharmacy and Early Formulation Development constitutes the Early Development organization in the US (EDUS) which provides 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 Senior Director of Analytics in Cambridge Crossing, the Principal Scientist is responsible for the analytical methods development, analyses, characterization, chromatographic chiral and achiral separation and purification for early and late phase development activities of small synthetic pharmaceutical molecules.Key Responsibilities:

Collaborate with Synthesis Development, Medicinal Chemistry, Process Chemistry and Process Engineering groups to support pre-development, early and late development activities.

Develop analytical methods for the separation of chiral and achiral molecules including by HPLC and LCMS, conduct analytical testing and chromatographic purification of synthetic intermediates and final materials by different techniques including reversed-phase, normal phase and super-critical fluid chromatography to support synthesis and process development.

Collaborate with synthetic chemists and process engineers for the identification of process impurities and decomposition products utilizing expertise in analytics and organic chemistry.

Develop and implement chiral platform analytical methods to support process chemistry and process engineering and provide local analytical support as needed.

Oversee the chiral and achiral chromatographic separation and purification of research compounds with medicinal chemistry as appropriate.

Collaborate with analytical scientists involved with chromatographic separation challenges to optimize these methods to support complex analyses of research compounds and related impurities.

Responsible for the proper maintenance and operation of the analytical equipment in the laboratories including HPLC, LCMS, Preparative Chromatography systems.

Handover chiral analytical methods as needed to our CMOs in preparation of Early Development activities to support GLP tox studies and early clinical trials.

Assist with the transfer of analytical methods from our CMOs to the late development CMC group as appropriate.

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

Basic Qualifications:

PhD in Organic Chemistry, Pharmaceutical Analytical Chemistry or related sciences, with a minimum of 8 years of experience within the pharmaceutical/biotech industry.

Expertise with the chromatographic separation of chiral and achiral molecules for the development of analytical methods needed for the separation and analysis of compounds including process chemistry impurities in pre-development, early and late CMC development.

Expertise with the purification and identification of chemical process impurities and degradation products.

Working knowledge and experience of pharmaceuticals in pre-development, early and late development.

Computer literacy with proficiency in Microsoft Office software, electronic notebook documentation.

Experience in preparing analytical reports as source documents for pre-development, early and late development.

Excellent communication abilities along with experience with good documentation practices.

Experience working with cross-functional teams.

Preferred Qualifications:

Hands-on experience working with complex chromatographic and preparative equipment with chiral and achiral compounds.

Track record of successfully developing chromatographic separation methods for the determination of both chiral and achiral compounds and purification of compounds for structural elucidation and in-vivo studies.

Working knowledge of predictive chromatographic software.

Ability to handle and prioritize multiple assignments.

Familiarity with the manufacture and analytical requirements for Drug Substances needed in early and late clinical trials.

Experience in writing reports for the documentation of chromatographic data.

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.

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.Pursue progress , discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !