Associate Scientist

Responsibilities

• Supports molecular assay design and development activities across multiple programs
• Conducts feasibility studies and contributes to technical approach selection (e.g., qPCR, RT-qPCR, multiplex strategies) under guidance
• Executes experimental plans and generates high-quality data to support assay performance and development milestones
• Contributes to analytical validation studies, including LoD, precision, reproducibility, and robustness
• Analyzes and interprets molecular data, identifies trends, and communicates results clearly to the team
• Supports troubleshooting efforts related to assay chemistry, workflow, and instrumentation
• Participates in cross-functional design reviews and provides technical input as appropriate
• Contributes to risk assessments (e.g., FMEA) and supports design control activities
• Supports development of QC strategies, reference material characterization, and analytical controls
• Contributes to regulatory documentation by generating data summaries and technical reports
• Collaborates with Manufacturing and Operations teams to support assay transfer and scale-up

• Maintains accurate and compliant laboratory documentation in accordance with quality and regulatory requirements
• Stays current on emerging molecular technologies and contributes to continuous improvement initiatives

• R&D and Assay Development Teams – Execute experiments, generate data, and support assay optimization
• Bioinformatics – Collaborate on target selection, sequence analysis, and assay performance
• Regulatory and Quality – Provide technical data and documentation to support submissions
• Manufacturing and Operations – Support assay transfer and process optimization
• Program Management – Communicate progress, risks, and timelines

• CROs and external partners – Support execution of external studies
• Reference material suppliers – Assist with qualification and performance monitoring

• Bachelor’s degree in Molecular Biology, Genetics, Biochemistry, Biomedical Sciences, or related discipline required

• 2–5 years of experience in molecular assay development or related field
• Experience working in regulated environments (FDA, ISO 13485, design control) preferred
• Demonstrated ability to independently design and execute experiments

• Experience with qPCR and RT-qPCR techniques
• Understanding of nucleic acid extraction, amplification, and detection

• Familiarity with multiplex assay development and optimization
• Experience with analytical validation and performance characterization
• Basic knowledge of sequencing technologies (Sanger and/or NGS)
• Strong troubleshooting and problem-solving skills
• Knowledge of design control and risk management principles
• Working knowledge of BSL-2 laboratory practices
• Strong data analysis, documentation, and communication skills