Details:
- Compensation: $150,000 - $200,000k
- Benefits: Medical, Dental, Vision
- Employment Classification: Direct Hire
- Status: On-Site
- Job ID: 20340
Position Summary
We are seeking a Senior Scientist with high expertise in molecular assay development to lead innovation in PCR, dPCR, and NGS workflows. This individual will be responsible for designing, developing, and validating cutting-edge assays for infectious disease, oncology, and control materials. The Senior Scientist will drive experimental strategy, assay optimization, and validation protocols, while contributing to intellectual property, publications, and cross-functional collaborations.
This is a senior-level, top-of-field role requiring proven scientific innovation, leadership, and a track record of success in bioengineering molecular workflows.
Key Responsibilities
Assay Development & Innovation
- Design, develop, and optimize qPCR, multiplex PCR, dPCR, and NGS-based assays.
- Lead experimental design, workflow optimization, and troubleshooting for high-complexity molecular diagnostics.
- Apply advanced bioengineering approaches to expand assay sensitivity, specificity, and throughput.
- Develop and maintain control materials, reference standards, and validation panels.
- Draft, execute, and oversee assay validation protocols, SOPs, and technical reports.
- Ensure compliance with regulatory and quality standards (CLIA, FDA, ISO 13485, IVDR where applicable).
- Collaborate with quality, regulatory, and clinical teams to ensure seamless technology transfer.
- Serve as a subject matter expert (SME) in molecular assay design, data interpretation, and performance evaluation.
- Supervise, mentor, and guide junior scientists, analysts, and research associates.
- Foster a collaborative environment that encourages innovation, learning, and continuous improvement.
- Work closely with cross-functional teams (bioinformatics, clinical operations, engineering, business development).
- Represent the company in scientific presentations, publications, and patent applications.
Qualifications
Required
- PhD in Molecular Biology, Genetics, Biochemistry, Bioengineering, or related discipline.
- 5–7+ years of postdoctoral or industry experience in molecular assay development.
- Proven hands-on expertise in PCR (qPCR, multiplex PCR, dPCR) and NGS workflows.
- 5+ years of experience in primer/probe design and evaluation (SYBR, TaqMan, or equivalent).
- Proficiency with design and analysis tools: Primer3, BLAST, OligoAnalyzer, or similar.
- Strong record of peer-reviewed publications and/or patents in molecular assay development.
- Experience in infectious disease and oncology assay development.
- Familiarity with regulatory standards: CLIA, FDA, ISO 13485, IVDR.
- Demonstrated success in technology transfer from R&D to clinical or commercial labs.
- Supervisory or leadership experience managing research teams.
- Strong bioinformatics or computational biology experience (NGS data pipelines, variant analysis).
- Recognized as a leader in molecular innovation, capable of taking projects from concept to commercialization.
- Balances deep technical expertise with strategic vision for assay development.
- A creative problem-solver with a rigorous approach to validation and compliance.
- Strong communicator with the ability to influence across teams and present scientific findings externally.
- Thrives in a fast-paced, high-growth environment with cross-disciplinary collaboration.