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Principal Scientist
3 months ago
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
The molecular Principal Scientist role is responsible for developing molecular assays and generation of research use genomics data in support of BMS clinical trial analysis. This includes but is not limited to responsibility for 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/or execution of biomarker analysis for BMS translational medicine and clinical programs.
- ** This position is 100% lab focused requiring onsite attendance. The individual is expected to work on multiple projects to support translational medicine and clinical programs. The individual works on genomics/transcriptomics strategy (assay, platform) per program requirements, protocol requirements, program biology and mechanism. Assays include but are not limited to broad genomic/GEP profiling, pharmacodynamic assays, target engagement assays, predictive, prognostic assays and technology platform development. Assay design and development: Develop the framework for assay development, qualification/validation protocols and timely, well-planned execution of assay and clinical analysis working with cross-functional teams. Additionally, the individual is expected to help assist with any troubleshooting of any assay performance-related activities. As an individual contributor operating within a matrix organization would facilitate the design, develop, optimize genomics and genetics biomarker assays and develop and execute the qualification/validation of these assays for clinical trial assays in house and/or potentially with external vendors.**:
- ** Key assay profiles likely to include NGS or PCR based gene expression systems, genotyping or variant analysis utilizing NGS or PCR or other methodologies.**:
- ** Evaluation of emerging technologies including new prep kits and developing expertise in assay methodology.**:
- ** Drafts experimental plans, including qualification protocols and reports, work instructions/SOPs, technology transfer documents, and study reports or summaries.**:
- ** Actively participate in internal/external collaboration and clinical study and biomarker execution teams as appropriate.**:
- ** Accurate record keeping of experiments and procedures.**:
- ** Act as a technology evangelist and help assess (including conducting due diligence and pilot projects to assess feasibility) and onboard relevant technologies working with matrixed teams per program requirements. Work closely with data analysis teams as well as sample management and clinical operation teams on programs. Provide mentorship and leadership within the MAD lab team. Work to develop a lean organization with highly efficient genomics processes and best practices.**
**Basic Qualifications**:
- Bachelor's Degree
- 8+ years of academic and / or industry experience
Or
- Master's Degree
- 6+ years of academic and / or industry experience
Or
- Ph.D. or equivalent advanced degree in the Life Sciences
- 4+ years of academic and / or industry experience
**Preferred Qualifications**:
- Expertise and demonstrated ability to develop assays, oversee assay validation inhouse or with external vendors, develop appropriate controls/ QC methodology, oversee clinical sample analysis and assay performance and help develop and deliver program genomics biomarker strategic plans. Expertise, in-depth hands-on experience is expected in genomics platforms (NGS, qPCR, variant analysis platforms) for assay development, qualification/validation, troubleshooting, and reviewing run QC data.
- 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.
- 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 team and matrixed team.
- 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
