Job Title: Senior Scientist I - Biomarkers and Clinical Bioanalyses

Location: Cambridge, MA

About the Job:

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:

Basic Qualifications:

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

Preferred Qualifications:

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.

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Pursue progress, discover extraordinary

Better 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 Only

Sanofi 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 Only

The salary range for this position is:

$100,500.00 - $145,166.66

All 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.