Analytical Sciences Director (Somerville)

Within R&D, Synthetics CMC Development at Sanofi is responsible for all aspects of synthetic/small molecule drug development, from candidate selection to product approval. This encompasses drug substance (DS) and oral drug product (DP) development, Analytical Sciences, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. Our mission is to serve patients through relentless innovation in synthetic drug development and by designing state-of-the-art manufacturing processes. To this end, our development model is focused on speed to clinic for early-stage programs and delivering safe, robust, and eco-designed late-stage and commercial processes.Responsibilities:Responsible for all analytical sciences activities related to Synthetic / Small Molecules and Solid Oral Dosage Forms at the Cambridge Crossing siteDevelop and apply advanced analytical strategies to drive Sanofi’s First in Class and Best in Class R&D programsDesign, develop and apply analytical technologiesDrive analytical sciences innovation according to our laboratory’s digitalization and automation road mapDevelop the people and the organization in line with Sanofi’s Take The Lead strategyKey Activities:StrategicParticipate in the strategic evolution for Analytical Sciences in-line with the Synthetics Platform and Global CMC Development strategy and project needsInterface with key partners (within CMC, R&D and M&S, and Research Platforms) as needed to deliver the pipeline & projectsPromote a “one-team” culture among scientists in DS, DP, Analytics and clinical dossier preparation and developmentLead the Digital Transformation within the organizationRepresent the company in internal and external forums ScientificLead transversely the analytical sciences teamDrive the analytical sciences activities related to process chemistry support, pre formulation support, control strategy development, stability studies for intermediates, starting materials, drug substance and drug product in all stages of developmentPropose constant upgrading of analytical technologies to offer technical innovations and to generate intellectual propertyScan the external environment to anticipate potential opportunities and to evaluate scientific and technological collaborations relevant to state-of-the-art analytical developmentOperationalEnsure resources are allocated to deliver on projects according to the defined prioritiesEnsure the transversal analytical support to other CMC Synthetics functionPropose proper analytical training and new technologies for the developmentOversee outsourced activities when applicable (applying outsourcing strategy defined by the CMC Platform) and know when to internalize activitiesReview and approve Scientific documentsPeopleManage transversely a dynamic Analytical Sciences teamAct as a role model for the management essentials through appropriate managerial attributes and behaviorsPromote clear decision making, coaching and feed-backAttract, hire, maintain, and motivate high quality working forceDevelop, coach, and empower team members to promote a high degree of personal accountability, successful teamwork and leadership skills. Serve as key scientific representative for Analytical Sciences, and to support rapid decision-making on projectsQualifications:BS inAnalytical Chemistry or related field with at least 14 years of relevant experience within the pharmaceutical industry ORMS Analytical Chemistry or related field with at least 12 years of relevant experience within the pharmaceutical industry ORPhD in Analytical Chemistry or related field with at least 10 years of relevant experience within the pharmaceutical industry.At least 3+ years demonstrated people management and leadership experience.Strong knowledge of pharmaceutical regulatory requirements (ICH guidelines, EMA/FDA regulations, and international standards)Proven experience in clinical trial documentation and regulatory dossier submissionStrong scientific track record in analytical sciences in R&DAdvanced scientific network within academia and industryAbility to align resources and management, execute and adapt as needed to achieve short and long-term goalsExperience in managing teams of high-level scientistsStrong knowledge in GMP, ICH requirements, pharmacopoeiaDemonstrated experience in clinical dossier and CTD submissionsSolid understanding of CMC aspects of drug development and related functions, including chemistry, physical quality and formulationsDemonstrated technical, and organizational skills; ability to work in a matrix organizationShow initiative and creativity in proposing, developing and executing ideasEncourage experimentation, educated risk taking and learning from failureLanguages: EnglishWhy 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.#GD-SP ​ #LI-SP #LI-Hybrid#vhdPursue 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!US and Puerto Rico Residents OnlySanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.North America Applicants OnlyThe salary range for this position is:$178,500.00 - $257,833.33All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.SummaryLocation: Cambridge, MAType: Full time