Senior Molecular Biologist

4 days ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Job Summary

Bristol-Myers Squibb Company is seeking a highly skilled Senior Molecular Biologist to join our team. As a Senior Molecular Biologist, you will be responsible for developing and optimizing molecular assays for clinical trial analysis. This includes genomics and gene expression profiling (GEP) biomarker assay technology/platform selection, evaluation of in-house or vendor choice per assay use requirements, development, optimization, qualification/validation, and execution of biomarker analysis for BMS translational medicine and clinical programs.

Key Responsibilities
  • Develop and optimize molecular assays for clinical trial analysis, including genomics and gene expression profiling (GEP) biomarker assay technology/platform selection.
  • Evaluate in-house or vendor choice per assay use requirements, and develop, optimize, qualify, and validate biomarker analysis for BMS translational medicine and clinical programs.
  • Work closely with cross-functional teams to design, develop, and execute assay and clinical analysis plans.
  • Develop and maintain a strong understanding of assay development and fit-for-purpose assay qualification requirements.
  • Provide subject matter expertise for functional lead stakeholders as required.
  • Act as a technology evangelist and help assess and onboard relevant technologies working with matrixed teams per program requirements.
Requirements
  • Bachelor's Degree in a Life Science field with 8+ years of academic and/or industry experience, or Master's Degree with 6+ years of experience, or Ph.D. with 4+ years of experience.
  • Significant experience and subject matter expertise in PCR, NGS, or GEP application, significant technology and lab experience is a must.
  • Expertise and demonstrated ability to develop assays, oversee assay validation in-house or with external vendors, develop appropriate controls/QC methodology, oversee clinical sample analysis, and assay performance.
  • Experience with additional technologies leveraged for ctDNA analysis and GEP analysis is considered a critical requirement for this role.
  • Understanding of fit-for-purpose genomics assay validation principles for clinical assays.
  • Expertise in serving as subject matter expert on technology-specific data structure, data analysis, data QC in working with data analysis teams and biostatistics teams.
  • Basic understanding of IP, contracting terms, and provisions.
  • Must have strong organizational, communication, interpersonal, and collaborative skills.
  • Must display excellent leadership and mentoring qualities for technical teams and matrixed teams.
Preferred Qualifications
  • Familiarity with genomics assay qualification/validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development).
  • Basic understanding of IVD quality system standards (21 CFR part 820, ISO13485) would be a plus.
  • Knowledge of clinical sample analysis regulatory and quality frameworks and guidance in the lab and at vendors (such as GCP, CLIA, CAP, and NYDOH).
About Us

Bristol-Myers Squibb Company is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. Our company is committed to innovation, urgency, accountability, inclusion, and integrity. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.

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