Sanofi
Senior Scientist I - Biomarkers and Clinical Bioanalyses
Sanofi, Cambridge, Massachusetts, United States, 02141
Senior Scientist I - Biomarkers and Clinical Bioanalyses
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are seeking a Senior Scientist to join the Functional Biomarker Team within Laboratory Sciences (Lab Sci), a global department in the Translational Medicine Unit (TMU) at Sanofi. In this role, the scientist will lead method development and validation of complex assays, implement testing strategies, and execute clinical projects within controlled timelines. The role also includes preparing reports suitable for regulatory submissions to support clinical development. The ideal candidate will have hands-on experience with Spectral flow cytometry instrumentation and troubleshooting, high-parameter panel development, and the analytical interpretation of results. This position operates in a matrixed global team environment and requires strong collaboration skills. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities:
Independently develop, validate, and implement complex bioanalytical assays to support testing in nonclinical and clinical studies, with a focus on immunophenotyping panels and/or receptor occupancy/density methods by flow cytometry Serve as responsible scientist for regulated studies, providing scientific oversight, data interpretation, and ensuring compliance with internal best practices and regulatory guidance Oversee and mentor junior analysts in method validation and sample testing; offer scientific rationale for assay development and troubleshooting Author SOPs, study plans, reports, and abstracts, producing high-quality documents requiring minimal editing Present scientific data to internal and external stakeholders Lead regulatory and safety compliance efforts in the laboratory; champion process improvement initiatives to drive operational excellence Manage multiple project commitments under tight timelines Serve as bioanalytical lead on global project teams Collaborate with global teams to design and implement testing strategies for ongoing and future clinical programs Ensure timely readiness of validated methods to meet critical deliverables Work with outsourcing operations and CROs to transfer and manage external testing; act as subject matter expert in reviewing and troubleshooting CRO development and validation studies Contribute to the TMU's mission in conducting reverse translational studies About You: Ph.D. in a life sciences field with 3+ years of bioanalytical industry experience in a regulated environment, OR Master's degree with 5+ years of experience, OR Bachelor's degree with 10+ years of experience A degree in Immunology, Biochemistry, or Biology is preferred Experience working with CROs and external testing partners, with the ability to lead technology transfer and troubleshoot assay validation Minimum 5+ years of experience with key analytical software (e.g., SoftMax, FlowJo, FCS Express), and proficiency in statistical software such as Excel, JMP, GraphPad Prism Strong written and oral communication skills, with demonstrated ability to collaborate effectively in a team Proven problem-solving skills and scientific leadership in assay troubleshooting and optimization Solid understanding of bioanalytical method development, industry best practices, and regulatory expectations (FDA/EMA) for method validation Experience in a GCLP-regulated environment supporting nonclinical and clinical development Experience supervising and guiding junior scientists in assay development and execution will be a plus Experience with Watson LIMS or similar laboratory information management systems Familiarity with electronic laboratory notebooks e.g. Benchling Understanding of biological sample collection techniques and suitability for different assay types Experience with software and equipment validation in regulated settings Background in developing cell-based assays and/or anti-drug antibody assays Experience contributing to regulatory filings Familiarity with clinical trial operations Terms of Employment:
People Management Responsibilities: None Travel Requirements: Minimal Start Date: As soon as possible Working Hours: Business hours What Makes This Position Unique?
The Lab Sci group plays a vital role in drug development, providing bioanalytical strategy and support from early discovery through clinical proof of concept. This position offers the opportunity to contribute across multiple programs, bringing high visibility and a chance to significantly impact the direction and success of clinical development initiatives. 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.
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are seeking a Senior Scientist to join the Functional Biomarker Team within Laboratory Sciences (Lab Sci), a global department in the Translational Medicine Unit (TMU) at Sanofi. In this role, the scientist will lead method development and validation of complex assays, implement testing strategies, and execute clinical projects within controlled timelines. The role also includes preparing reports suitable for regulatory submissions to support clinical development. The ideal candidate will have hands-on experience with Spectral flow cytometry instrumentation and troubleshooting, high-parameter panel development, and the analytical interpretation of results. This position operates in a matrixed global team environment and requires strong collaboration skills. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities:
Independently develop, validate, and implement complex bioanalytical assays to support testing in nonclinical and clinical studies, with a focus on immunophenotyping panels and/or receptor occupancy/density methods by flow cytometry Serve as responsible scientist for regulated studies, providing scientific oversight, data interpretation, and ensuring compliance with internal best practices and regulatory guidance Oversee and mentor junior analysts in method validation and sample testing; offer scientific rationale for assay development and troubleshooting Author SOPs, study plans, reports, and abstracts, producing high-quality documents requiring minimal editing Present scientific data to internal and external stakeholders Lead regulatory and safety compliance efforts in the laboratory; champion process improvement initiatives to drive operational excellence Manage multiple project commitments under tight timelines Serve as bioanalytical lead on global project teams Collaborate with global teams to design and implement testing strategies for ongoing and future clinical programs Ensure timely readiness of validated methods to meet critical deliverables Work with outsourcing operations and CROs to transfer and manage external testing; act as subject matter expert in reviewing and troubleshooting CRO development and validation studies Contribute to the TMU's mission in conducting reverse translational studies About You: Ph.D. in a life sciences field with 3+ years of bioanalytical industry experience in a regulated environment, OR Master's degree with 5+ years of experience, OR Bachelor's degree with 10+ years of experience A degree in Immunology, Biochemistry, or Biology is preferred Experience working with CROs and external testing partners, with the ability to lead technology transfer and troubleshoot assay validation Minimum 5+ years of experience with key analytical software (e.g., SoftMax, FlowJo, FCS Express), and proficiency in statistical software such as Excel, JMP, GraphPad Prism Strong written and oral communication skills, with demonstrated ability to collaborate effectively in a team Proven problem-solving skills and scientific leadership in assay troubleshooting and optimization Solid understanding of bioanalytical method development, industry best practices, and regulatory expectations (FDA/EMA) for method validation Experience in a GCLP-regulated environment supporting nonclinical and clinical development Experience supervising and guiding junior scientists in assay development and execution will be a plus Experience with Watson LIMS or similar laboratory information management systems Familiarity with electronic laboratory notebooks e.g. Benchling Understanding of biological sample collection techniques and suitability for different assay types Experience with software and equipment validation in regulated settings Background in developing cell-based assays and/or anti-drug antibody assays Experience contributing to regulatory filings Familiarity with clinical trial operations Terms of Employment:
People Management Responsibilities: None Travel Requirements: Minimal Start Date: As soon as possible Working Hours: Business hours What Makes This Position Unique?
The Lab Sci group plays a vital role in drug development, providing bioanalytical strategy and support from early discovery through clinical proof of concept. This position offers the opportunity to contribute across multiple programs, bringing high visibility and a chance to significantly impact the direction and success of clinical development initiatives. 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.