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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.
The Principal 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.
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).
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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