Job Title: Senior Principal Scientist I - Functional Biomarkers
Location: Cambridge, MA
Functional group leader in the US Laboratory Sciences group, a global department within the Translational Medicine Unit of Sanofi. The individual in this position will lead a group of scientists and analysts to develop, validate and implement complex immunophenotyping panels and functional biomarker assays in a regulated environment. The successful candidate should have an extensive background in flow cytometry instrumentation and troubleshooting, high-parameter panel development, and cell sorting along with expertise in assay design, method validation, and analytical interpretation of results along with proven people management skills.
Main Responsibilities:- Lead and manage local teams to develop, validate, and implement complex cell staining panels upwards of 30+ colors according to, or exceeding the highest scientific and applicable regulatory (GLP, GCLP) standards.
- Oversee method development and/or transfer and implementation of complex immunophenotyping panels at dedicated CROs.
- Serve as a flow cytometry subject matter expert; provide scientific oversight and data interpretation and ensure data generated internally or with CROs meets compliance requirements according to internal best practices and regulatory guidance.
- Serve as bioanalytical lead on global project teams:
- Work with global teams to develop and operationalize testing strategies to support new and ongoing clinical programs.
- Ensure that all methods are in place to meet critical deliverables.
- Lead team to prepare high quality standard operating procedures, study plans and reports.
- Lead global Sanofi efforts to develop best practices and guidance documents for regulated bioanalysis.
- Contribute to implementation of best practices industry-wide through participation in external scientific organizations
- Take a leadership role in ensuring regulatory and safety compliance in the laboratory; promote operational excellence by leading process improvement efforts.
- Prioritize multiple project commitments under the confines of challenging timelines. Plan proactively, anticipating challenges and future goals. Make decisions readily understanding the impact on Sanofi success and demonstrate agility relating to change.
- Lead efforts to implement AI tools to streamline method development and data analysis workflows.
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About youBasic Qualifications
- Ph.D. degree in the field of immunology, biochemistry, biology, or other life-science field with 7+ years of post-graduate industry or research experience, or Master's degree in a similar field with 10+ years of industry or research experience.
- Expertise with flow cytometer instruments and their associated software including AI tools.
- A diverse skillset in bioanalytical assay techniques such as cell culture, cell imaging, ligand binding, receptor occupancy or enzyme activity assays.
- Outstanding written and oral communication skills along with the ability to work collaboratively in a team setting.
- Demonstrated knowledge and skills in solving scientific problems, ability to troubleshoot.
- Proven ability to lead teams and direct the work of staff members at all levels.
Preferred Qualifications:
- Experience in immunology.
- Demonstrated experience in complex immunophenotyping assay development and implementation in clinical trials in line with industry's best practices and current regulatory expectations for validation of flow cytometry assays.
- Experience working with a laboratory information system, such as Watson LIMS, to manage sample tracking and data analysis.
- Experience using an electronic laboratory notebook.
- Knowledge of biological sample collection techniques and their suitability for different types of analysis.
- Experience validating software and equipment in a regulated laboratory setting.
- Experience in implementation of a variety of methods, such as ligand binding or mass spectrometry, in a regulated setting.
- Experience working with Quality Assurance in a compliance-related environment.
- Knowledge of requirements for working in a regulated environment (GLP, GCLP, CLIA) in support of nonclinical and/or clinical development projects.
- Exposure to working with Quality teams in a GxP environment.
- Experience supporting regulatory filings.
- Experience with clinical trial operations.
The salary range for this position is:
$148.500,00 - $214.500,00
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.
