Schedule: Monday–Friday, 9:00 AM–5:00 PM
Pay Rate: $85/hr to $96/hr on W2
Contract: 3+ Months with Possibility of extension
Job Overview
We are seeking a Sr. Scientist to lead verification and validation studies supporting innovative NGS-based multi-cancer early detection solutions. This role will involve experimental design, data analysis, technical documentation, cross-functional collaboration, and providing scientific guidance to project teams.
Key Responsibilities
- Lead verification and validation studies supporting molecular diagnostic product development and regulatory submissions.
- Design and execute bench-level experiments involving molecular biology, biochemistry, NGS, and genomics.
- Analyze and interpret experimental data and provide recommendations for project direction.
- Collaborate with cross-functional teams including bioinformatics, biostatistics, regulatory, quality, clinical laboratory, and medical teams.
- Develop study plans, protocols, procedures, technical reports, and documentation.
- Present and communicate scientific findings to project teams and leadership.
- Provide technical guidance and mentorship to junior scientists.
- Support process improvements, regulatory compliance, and quality system requirements.
- Serve as a technical leader/subject matter expert on complex projects.
Minimum Qualifications
- PhD in Life Sciences, Medical Technology, Clinical Laboratory Science, Chemistry, Biology, or a related field; or Master's + 4 years of related experience; or Bachelor's + 6 years of related experience.
- 5+ years of industry or academic experience in biology and/or chemistry.
- 3+ years of experience in medical device/IVD, biotech, life sciences, or pharmaceutical industries.
- Strong hands-on experience with molecular biology and/or biochemical techniques.
- Experience with NGS, genomics, and molecular diagnostics.
- Understanding of GMP, ISO, and Quality Systems.
- Experience with statistical analysis/software such as JMP.
- Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
- Must be authorized to work in the U.S. without sponsorship.
Preferred Qualifications
- 8+ years of Life Sciences, Chemistry, or related research experience.
- 6+ years in medical device/IVD, biotech, life sciences, or pharmaceutical industries.
- Experience in GMP and/or ISO environments.
- Experience with genomic databases and computational tools.
- Molecular diagnostics or clinical laboratory experience.
- Extensive hands-on experience developing, optimizing, and troubleshooting NGS workflows for DNA/RNA clinical samples.
- Experience analyzing NGS data and developing genomic/epigenomic biomarkers related to cancer.
- Experience with analytical validation and product development in an LDT or FDA-regulated environment.
Additional Requirements
- Ability to lift up to 25 lbs.
- Comfortable working with computers/tablets and performing fine finger manipulation as required.
- Ability to work independently while effectively collaborating with multidisciplinary teams.