Job Description

Scientific - Associate Scientist, Assay Development (Molecular)

6 Months

San Diego CA, 92121

Description:

• 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

Parameter Description

• 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
• The KeyStakeholders Internal Customers 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 External Customers
• CROs and external partners – Support execution of external studies •
• Reference material suppliers – Assist with qualification and performance monitoring

The Individual Education

• Bachelor's degree in Molecular Biology, Genetics, Biochemistry, Biomedical Sciences, or related discipline required
• Master's degree preferred Experience Associate Scientist: • 2–5 years of experience in molecular assay development or related field Scientist: • 5–8 years of experience in molecular assay development or diagnostics
• Experience working in regulated environments (FDA, ISO 13485, design control) preferred
• Demonstrated ability to independently design and execute experiments Technical Skills
• Experience with qPCR and RT-qPCR techniques
• Understanding of nucleic acid extraction, amplification, and detection

Parameter Description

• 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

How We Work At

• our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: § Thrive Together – Collaborate intentionally, grow as a team § Make It Happen – Focus on priorities, embrace continuous improvement § Commit to Service – Cultivate a service mindset § Embrace Inclusion – Be open and authentic, welcome diverse perspectives

The Work

Environment Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

The Physical

Demands Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

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