R&D Senior Scientist (Infectious Disease)

Location: Hybrid role based in Irvine, California, United States; employees must live within commuting distance of the office.

Base salary: $121,200–$166,700 annually, plus eligibility for a variable annual bonus.

Company

Develops, manufactures, and markets research and clinical diagnostic products while advancing life science and healthcare.

What you will do

• Advance new and existing infectious disease and core quality control products.
• Design and execute experiments, laboratory studies, and testing for in vitro diagnostics quality control products.
• Lead design verification and validation activities, review design inputs, and ensure design control goals are completed within budget.
• Use verification data to support critical design decisions and conduct failure analysis.
• Coordinate test-tool development to simulate errors and faults and obtain objective outputs.
• Communicate results to leadership and project management while mentoring colleagues and collaborating across scientific, engineering, manufacturing, marketing, and regulatory functions.

Requirements

• Minimum bachelor's degree in life science or a related technical discipline; a PhD in biology, biochemistry, microbiology, or a closely related discipline is preferred.
• At least eight years of industry experience working in an FDA-regulated environment, preferably in in vitro diagnostics.
• Experience working with potentially infectious human pathogens in controlled laboratory conditions.
• Experience with serological and/or molecular methods for infectious disease detection.
• Ability to follow instructions and perform moderately complex laboratory studies independently and collaboratively.
• Ability to write clear plans, reports, and SOPs and present progress to colleagues and senior management.
• Strong communication, critical thinking, planning, organizational, data-review, problem-solving, and growth-mindset skills.
• Practical knowledge of Quality Systems Regulations, GMP, Design Control, Design for Six Sigma, and ISO 13485.
• Solid experience with Design of Experiments, statistical methods, Lean Practices, and structured problem solving.

Nice to have

• Practical knowledge of lateral flow, EIA, ddPCR, NAT, and related manual and automated testing platforms used in infectious disease testing in clinical and blood donor screening centers.
• Experience with domestic and European regulations, including FDA, CE Mark, and MDSAP.

Culture & Benefits

• Collaborative work with scientists, project management, engineering, manufacturing, marketing, regulatory affairs, and other functions.
• Medical plans, HSA funds, fertility support, life and disability coverage, paid parental leave, and 401(k) with profit sharing.
• Employee stock purchase program, mental health support, learning and development opportunities, education benefits, student debt relief, pet insurance, wellness support, paid time off, and employee resource groups.
• Equal employment opportunity employer welcoming candidates from diverse backgrounds.