Sr. Scientist

The Position:

We are seeking an experienced Senior Scientist to lead the development of next-generation MRD assays from concept through clinical lab implementation. This individual will drive technical strategy, experimental design, and scientific decision-making across assay development, automation, and workflow optimization. The ideal candidate has direct experience in NGS-based oncology diagnostics and a proven track record of developing clinical assays in regulated environments through cross-functional leadership and scientific innovation.

Responsibilities:

• Lead the development, verification, and transfer of NGS-based MRD assays from concept through clinical lab implementation.
• Independently develop workflows suitable for clinical operations, including automation, QC, throughput requirements, and LIMS integration.
• Conceive innovative solutions and develop rigorous experimental strategies to advance assay performance, sensitivity, robustness, scalability, and operational readiness.
• Design and execute feasibility, optimization, and verification studies, with independent ownership of objectives, study design, planning, execution, and analysis guided by systematic application of biochemistry and bioinformatic principles
• Author and review protocols, SOPs, reports, requirements, risk assessments, and design control documentation supporting product development and regulatory compliance.
• Serve as a subject matter expert in NGS, oncology genomics, and ctDNA/MRD technologies, leading troubleshooting and resolution of complex technical challenges.
• Collaborate cross-functionally with Bioinformatics, Data Science, Operations, Clinical Laboratory, Automation, SW/LIMS, Quality, and Regulatory teams to develop and implement robust diagnostic products.
• Support technology transfer, assay implementation, and commercialization activities, including training and mentoring laboratory personnel and junior scientists.

Who You Are:

• NGS assay expert with deep theoretical and hands-on knowledge of the biochemistry underlying multi-component molecular biology methods at the sample preparation and assay level.  Has a track record of successfully troubleshooting and optimizing molecular biology techniques/assays in a developed workflow.
• Bench scientist eager to participate directly in laboratory work independently and in cooperation/coordination with others. Must be able to mentor others and effectively manage (design, monitor, complete, troubleshoot) laboratory project tasks performed in the hands of others.
• Rigorous and skilled in NGS data analysis, with command of common and assay-specific metrics and excellent data analysis and visualization skills using common statistical methods and software (JMP, R, Python)
• Successful product developer with experience writing requirements and systematically building products under global PDP
• Innovative technical leader eager to tackle complex scientific programs and generate solutions to challenging technical problems.
• Team player who elevates performance within and across functions through technical collaboration, mentorship of junior scientists, and positive attitude
• Practical developer with the ability to evaluate multiple technical variables and translate data into actionable decisions that consider program priorities, timelines, and cross-functional requirements
• Clear and effective communicator with exceptional written and verbal communication skills
• Flexible and open-minded contributor in the face of shifting resources & priorities
• Passionate about developing diagnostics that improve outcomes for cancer patients.

Qualifications:

• PhD in Molecular Biology, Genetics, Biochemistry, or a related field.
• 6 – 7 years of post-doctoral and relevant industry experience focused on NGS wet-lab experimentation, preferably in a Product Development environment
• Extensive experience developing NGS-based assays for clinical, diagnostic, or regulated applications, including the development of library preparation chemistries and direct experience with common clinical sample matrices (blood, tissue, FFPE)
• Experience with automation and design and development of high-throughput workflows
• Strong command of NGS-based genomic data analysis, interpretation, and visualization, including direct experience with common statistical methods and software (JMP, R, Python)
• Strong background in cancer genomics, liquid biopsy, ctDNA, or related molecular diagnostic technologies. Direct experience developing MRD or liquid biopsy diagnostics a plus.
• Experience with LDT product development under design control and quality system and regulatory requirements (CAP/CLIA, NYSDOH)
• Proven ability to independently lead complex technical projects.

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