Principal Scientist, Biomarker Bioanalytical Sciences
$141,000–$188,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Lead assigned discovery and development programs as the bioanalytical representative, developing and executing fit-for-purpose approaches for PK, ADA, TE, PD, and disease biomarkers. Design and oversee assay development, analytical validation, and sample analysis plans while providing scientific leadership for CRO oversight, including troubleshooting, data review, and vendor management. Review protocols, validation reports, and data packages to ensure regulatory compliance and fitness-for-purpose, supporting investigations into assay issues and root cause analyses. Contribute scientific content and data packages for IND, CTA, and BLA submissions, and prepare documentation for audits and inspections. Interpret bioanalytical data to communicate findings and recommendations to project teams and stakeholders.
Required Qualifications
- PhD or MS in Immunology, Cellular and Molecular Biology, or a related scientific field
- PhD with 5+ years of relevant industry experience
- MS with 8+ years of relevant industry experience
- Experience developing and implementing biomarker and bioanalytical assays across discovery and clinical development settings
- Advanced technical expertise in method development and validation in a regulated environment
- Experience supporting sample analysis and data review
- Familiarity with biomarker and bioanalytical requirements supporting regulatory filings and clinical development programs
- Experience contributing bioanalytical content to IND, CTA, BLA, and other regulatory submissions
- Experience providing scientific oversight of CROs and external laboratory partners
- Excellent technical writing, analytical interpretation, and communication skills
- Ability to work independently and effectively influence cross-functional teams in a matrixed environment
- Strong verbal and written communication skills with the ability to tailor presentations to diverse audiences
- Highly flexible, results-oriented, and comfortable operating in a fast-paced, dynamic environment
- Proficiency with ligand-binding and cell-based assay technologies across multiple platforms
- Industry experience in biomarker sciences, translational research, or bioanalytical sciences supporting drug development programs
Desired Qualifications
- Experience supporting clinical biomarker programs
- Strong publication and scientific communication record
- Experience authoring and defending bioanalytical content for IND, CTA, BLA, MAA, and other global regulatory submissions
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