Lead Scientist, Immunoassay & Biosensor R&D

ACON Laboratories; San Diego (CA); On-site; USD 81,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Paid Holidays

Job summary

ACON Laboratories is seeking a Scientist to develop projects from early development through clinical studies, guiding research priorities and progress. You will design experiments, analyze data, and provide recommendations to advance product development.

The role may lead a team of Scientists, Research Associates, and Technicians, requiring strong immunoassay expertise and regulatory awareness for FDA 510K submissions.

Qualifications

• Ph.D. in chemistry, biochemistry or related field or BS with 3–5 years of Scientist experience in IVD.
• 3–5 years of assay development and improvement experience in a quality system environment.

Responsibilities

• Develop projects from early development to product transfer and clinical studies.
• Lead or participate in prioritization and planning of research activities.
• Design experiments, develop procedures, and train staff as needed.
• Investigate and solve complex technical problems and perform data analysis.
• Assist with 510K submissions and regulatory documentation.
• May supervise a small team of Scientists, RAs, or Technicians.

Skills

Lateral flow immunoassay

Fluorescence immunoassay

Immunoassay development

Infection disease immunoassay

Root-cause analysis

Project management

Troubleshooting

Education

Ph.D. in chemistry/biochemistry or related

BS + 3–5 years in Scientist role in IVD

Tools

Excel

Job description

ACON Laboratories is seeking a Scientist to develop projects from early development through clinical studies, guiding research priorities and progress. You will design experiments, analyze data, and provide recommendations to advance product development.

The role may lead a team of Scientists, Research Associates, and Technicians, requiring strong immunoassay expertise and regulatory awareness for FDA 510K submissions.