Principal Scientist, Molecular Genomics Full-time

Principal Scientist, Molecular Genomics

The Principal Scientist is responsible for developing, optimizing, qualifying, validating, and executing molecular biomarker assays to support translational medicine and clinical programs. This laboratory-based role focuses on PCR and NGS-based genomics and transcriptomics technologies, including gene expression profiling (GEP), genotyping, variant analysis, ctDNA, and related molecular platforms. The successful candidate will provide scientific leadership in assay strategy, technology evaluation, biomarker development, clinical sample analysis, vendor oversight, and cross-functional collaboration to generate high-quality genomics data that informs clinical trial decision-making and advances Bristol Myers Squibb's research and development pipeline.

Key Responsibilities:

• Lead the development and implementation of genomics and transcriptomics biomarker strategies for translational medicine and clinical programs.
• Select and evaluate molecular assay technologies and platforms based on program, protocol, and biological requirements.
• Design, develop, optimize, qualify, validate, and execute biomarker assays supporting clinical and translational research.
• Support genomic and gene expression profiling (GEP) assays, pharmacodynamic assays, target engagement assays, predictive assays, prognostic assays, and technology platform development.
• Develop assay qualification and validation plans, protocols, reports, and associated technical documentation.
• Generate, analyze, and interpret qualification and validation datasets to support fit-for-purpose clinical assay deployment.
• Perform hands-on laboratory work utilizing PCR, qPCR, NGS, gene expression, genotyping, variant analysis, and related molecular technologies.
• Troubleshoot assay performance issues and implement corrective actions to ensure assay robustness and reproducibility.
• Oversee clinical sample analysis and assay execution performed internally or through external vendors.
• Review assay quality control metrics, assay performance data, and study deliverables.
• Serve as a subject matter expert on genomics technologies, assay performance, data quality, and biomarker strategies.
• Evaluate emerging technologies, assay methodologies, sample preparation kits, and workflow improvements.
• Conduct due diligence assessments and pilot studies to determine feasibility and applicability of new technologies.
• Lead technology transfer activities and support implementation of new platforms and workflows.
• Draft and maintain experimental plans, qualification protocols, validation reports, SOPs, work instructions, study reports, and technology transfer documents.
• Collaborate closely with data analysis, biostatistics, sample management, clinical operations, project management, and other cross-functional teams.
• Participate in biomarker execution teams, clinical study teams, and internal/external scientific collaborations.
• Provide scientific guidance and technical expertise to functional stakeholders and program teams.
• Maintain accurate and compliant records of experiments, procedures, and study activities.
• Mentor junior scientists and contribute to the development of a highly efficient and innovative genomics laboratory environment.
• Drive continuous improvement initiatives, operational excellence, and best practices across genomics workflows and processes.

Qualifications & Experience:

• Bachelor's degree in Life Sciences or related discipline with 8+ years of academic and/or industry experience; or
• Master's degree in Life Sciences or related discipline with 6+ years of academic and/or industry experience; or
• Ph.D. or equivalent advanced degree in Life Sciences with 4+ years of academic and/or industry experience.
• Ability and willingness to work in a laboratory environment for 100% of the work schedule.
• Extensive experience with PCR, qPCR, NGS, GEP, and other genomics-based technologies.
• Strong hands-on laboratory expertise in molecular assay development and execution.
• Proven experience developing clinical genomics assays in pharmaceutical, biotechnology, diagnostics, or clinical laboratory settings.
• Demonstrated expertise in assay development, optimization, qualification, validation, troubleshooting, and lifecycle management.
• Experience overseeing assay validation activities performed internally and through external vendors.
• Strong understanding of assay controls, quality control methodologies, and assay performance monitoring.
• Experience supporting clinical sample analysis and biomarker-driven clinical programs.
• Expertise with genomics platforms such as NGS, qPCR, gene expression profiling, genotyping, and variant analysis technologies.
• Significant experience reviewing assay run metrics, QC data, and performance trends.
• Hands-on experience with ctDNA technologies and gene expression profiling platforms.
• Strong understanding of fit-for-purpose validation principles for clinical genomics assays.
• Knowledge of genomics data structures, quality control processes, and collaboration with bioinformatics and biostatistics teams.
• Experience developing and executing genomics biomarker strategies that support clinical development programs.
• Familiarity with technology assessment, vendor selection, and implementation of new laboratory platforms.
• Working knowledge of intellectual property considerations and contracting principles.
• Excellent organizational, project management, and problem-solving skills.
• Strong written, verbal, and interpersonal communication skills.
• Demonstrated ability to work effectively in cross-functional and matrixed organizations.
• Proven leadership, mentoring, and team development capabilities.