Job Description
Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. 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.
The molecular genomics Sr. 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.
The Sr. Scientist candidate must have a strong technical background in PCR and NGS-based genomics and transcriptomics and its application in clinical programs, specific requirements are listed below:
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.
A significant part of time will be spent overseeing assay/workflow development and generation/analysis of qualification/validation data. A strong understanding of assay development and fit for purpose assay qualification requirements will be essential.
In case of outsourced studies, the individual will provide subject matter expertise and oversight of assay development and execution of sample analysis including review of QC data, working in tandem with the TS&Dx Project Management team and other enabling cross-functional teams.
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.
Providing subject matter expertise for functional lead stakeholders as required.
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.
Additional Qualifications/Responsibilities 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:
The successful candidate must be capable of working and operating in a laboratory environment for the entirety of their work schedule.
Significant experience and subject matter expertise in PCR, NGS or GEP application, significant technology and lab experience is a must.
The candidate must demonstrate significant work experience in clinical assay development for genomics assets preferably in a pharma, biotech, diagnostic or clinical lab setting.
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.
Expertise in serving as subject matter expert on technology specific data structure, data analysis, data QC in working with data analysis team 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 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 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).
Job Tags
Part time, Work experience placement,