Senior Principal Scientist I - Functional Biomarkers
Sanofi
July 02, 2026
Remote friendly (Cambridge, MA)
United States
$148,500 - $214,500 USD yearly
Clinical Research and Development
Main Responsibilities:
- Lead and manage local teams to develop, validate, and implement complex cell staining panels (30+ colors) per GLP/GCLP and regulatory standards.
- Oversee method development and/or transfer and implementation of complex immunophenotyping panels at dedicated CROs.
- Serve as flow cytometry subject matter expert: scientific oversight, data interpretation, and ensuring compliant data from internal work and CROs.
- Serve as bioanalytical lead on global project teams:
- Develop and operationalize testing strategies for clinical programs.
- Ensure methods are in place to meet critical deliverables.
- Lead preparation of high-quality SOPs, study plans, and reports.
- Lead global efforts to develop best practices and guidance documents for regulated bioanalysis.
- Take a leadership role in regulatory and laboratory safety compliance; drive process improvement.
- Prioritize multiple projects under challenging timelines; plan proactively and adapt to change.
- Lead implementation of AI tools to streamline method development and data analysis workflows.
Qualifications:
- Ph.D. in immunology, biochemistry, biology, or related life science with 7+ years industry/research experience, or Master’s with 10+ years.
- Expertise with flow cytometer instruments and associated software (including AI tools).
- Bioanalytical assay expertise (e.g., cell culture, cell imaging, ligand binding, receptor occupancy, enzyme activity assays).
- Excellent written/oral communication; collaborative team skills.
- Proven troubleshooting skills and ability to solve scientific problems.
- Proven people leadership and ability to direct staff.
Preferred Qualifications:
- Immunology experience; complex immunophenotyping assay development/clinical trial implementation.
- Watson LIMS (or similar) and electronic laboratory notebook experience.
- Regulated validation experience (software/equipment); experience with ligand binding or mass spectrometry.
- QA/GxP exposure; GLP/GCLP/CLIA knowledge for nonclinical/clinical development.
- Regulatory filings and clinical trial operations experience.
- Lead and manage local teams to develop, validate, and implement complex cell staining panels (30+ colors) per GLP/GCLP and regulatory standards.
- Oversee method development and/or transfer and implementation of complex immunophenotyping panels at dedicated CROs.
- Serve as flow cytometry subject matter expert: scientific oversight, data interpretation, and ensuring compliant data from internal work and CROs.
- Serve as bioanalytical lead on global project teams:
- Develop and operationalize testing strategies for clinical programs.
- Ensure methods are in place to meet critical deliverables.
- Lead preparation of high-quality SOPs, study plans, and reports.
- Lead global efforts to develop best practices and guidance documents for regulated bioanalysis.
- Take a leadership role in regulatory and laboratory safety compliance; drive process improvement.
- Prioritize multiple projects under challenging timelines; plan proactively and adapt to change.
- Lead implementation of AI tools to streamline method development and data analysis workflows.
Qualifications:
- Ph.D. in immunology, biochemistry, biology, or related life science with 7+ years industry/research experience, or Master’s with 10+ years.
- Expertise with flow cytometer instruments and associated software (including AI tools).
- Bioanalytical assay expertise (e.g., cell culture, cell imaging, ligand binding, receptor occupancy, enzyme activity assays).
- Excellent written/oral communication; collaborative team skills.
- Proven troubleshooting skills and ability to solve scientific problems.
- Proven people leadership and ability to direct staff.
Preferred Qualifications:
- Immunology experience; complex immunophenotyping assay development/clinical trial implementation.
- Watson LIMS (or similar) and electronic laboratory notebook experience.
- Regulated validation experience (software/equipment); experience with ligand binding or mass spectrometry.
- QA/GxP exposure; GLP/GCLP/CLIA knowledge for nonclinical/clinical development.
- Regulatory filings and clinical trial operations experience.