Bioanalysis & Biomarker Outsourcing Lead

Sanofi; Morristown (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14 weeks)

Career development opportunities

Job summary

Sanofi in Morristown, NJ is seeking a Bioanalysis and Biomarker Outsourcing Manager to oversee outsourced bioanalytical and biomarker activities across preclinical and clinical studies. You will ensure high-quality data delivery, regulatory compliance, and efficient vendor governance.

The role requires building strong cross-functional partnerships, driving process improvements, and maintaining timelines and budgets while collaborating with internal teams and external partners.

Qualifications

• Bachelor's degree in a biological science required; advanced degree preferred.
• Minimum 5 years in pharma/biotech/CRO with regulated bioanalysis or biomarker work.
• Experience managing outsourced biomarker and bioanalytical studies.
• Solid knowledge of GxP and quality systems; vendor oversight experience.

Responsibilities

• Partner with Biomarker and Precision Medicine teams to develop biomarker strategies for clinical studies.
• Oversee external vendors for analytical services, provide scientific oversight.
• Manage budgets, forecasts, and resource allocation for biomarker operations.
• Coordinate with QA for audits and regulatory inspections.
• Interface with Regulatory Agencies and internal stakeholders to support submissions.

Skills

Biomarker strategies

Vendor management

GxP knowledge

Bioanalytical expertise

Clinical operations

Education

Bachelor's degree in Biology, Biochemistry, Pharmacology

Master's or Ph.D. preferred

Tools

LIMS

Regulatory documentation systems

Job description

Sanofi in Morristown, NJ is seeking a Bioanalysis and Biomarker Outsourcing Manager to oversee outsourced bioanalytical and biomarker activities across preclinical and clinical studies. You will ensure high-quality data delivery, regulatory compliance, and efficient vendor governance.

The role requires building strong cross-functional partnerships, driving process improvements, and maintaining timelines and budgets while collaborating with internal teams and external partners.