Scientist – Assay Development (NGS)

We are seeking a highly motivated Scientist – Assay Development to join our R&D team supporting the development of Research Use Only (RUO) and CE-IVD/IVD products for Next-Generation Sequencing (NGS) applications.

This role is ideal for a hands-on molecular biology scientist with experience in assay development, NGS workflows, and laboratory research within a regulated product development environment. The successful candidate will contribute to the design, optimization, validation, and documentation of molecular assays while collaborating with cross-functional R&D teams.

Key Responsibilities

Laboratory Research & Assay Development

• Design, execute, and optimize molecular biology experiments independently.
• Develop and troubleshoot assays involving PCR, qPCR, nucleic acid extraction, and NGS library preparation.
• Perform assay characterization, reagent optimization, and verification studies.
• Operate automated liquid handling systems and sequencing instrumentation.
• Prepare reagents, buffers, and laboratory materials following SOPs.

Data Analysis & Documentation

• Analyze experimental data and summarize scientific findings.
• Maintain accurate laboratory records using electronic or paper lab notebooks.
• Prepare technical reports, verification documents, SOPs, and Design History File (DHF) documentation.
• Present project updates and experimental results to internal teams.

Quality & Laboratory Operations

• Perform work in compliance with ISO 13485, QSR, OSHA, and internal quality systems.
• Support design control documentation and regulated product development activities.
• Maintain laboratory equipment, reagent inventory, and calibration records.
• Collaborate with cross-functional teams to support assay development projects.

Required Qualifications

• Bachelor's degree in Molecular Biology, Biological Sciences, Biochemistry, Chemistry, or related field (Master's or PhD preferred).
• Minimum 5 years of laboratory experience (less with advanced degree).
• Strong experience with molecular biology techniques including:
• PCR
• qPCR
• DNA/RNA extraction
• NGS library preparation
• Experience with assay development, optimization, troubleshooting, and validation.
• Strong laboratory documentation and data analysis skills.
• Excellent communication and teamwork skills.

Preferred Qualifications

• Experience with Next-Generation Sequencing (NGS) workflows.
• Knowledge of target enrichment and sequencing technologies.
• Experience working under Design Controls, ISO 13485, and QSR.
• Experience supporting IVD or CE-IVD product development.