quality controlstatistical methodsfailure analysisdesign controldesign of experimentsclinical chemistryin vitro diagnosticsimmunoassay
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Текст:
Hirify AI/Оригинал
TL;DR
R&D Senior Scientist (In Vitro Diagnostics): Developing and supporting quality control products for clinical diagnostics with an accent on experimental design, design verification and validation, and quality-system compliance. Focus on failure analysis, advanced statistical methods, test-tool development, and communicating scientific data to guide product decisions.
Location: Hybrid role based in Irvine, California, United States, with the employee required to live within commuting distance of the office.
Salary: $121,200–$166,700 base salary, plus eligibility for a variable annual bonus.
Company
hirify.global develops, manufactures, and markets research and clinical diagnostic products, supporting scientific discovery and healthcare outcomes.
What you will do
Develop and support innovative in vitro diagnostics quality control products.
Design and execute experiments, design verification and validation plans, and reviews of design input requirements.
Ensure design control goals are completed with appropriate quality, timing, and budget adherence.
Use verification data to influence design decisions and communicate observations and results.
Plan, execute, document, and report failure-analysis experiments, including development of test tools that simulate errors and faults.
Partner with scientists, project management, manufacturing engineering, marketing, regulatory affairs, leadership, and other stakeholders to deliver products to market.
Requirements
Bachelor’s degree in biology, biochemistry, or biological sciences and a minimum of 8 years of industry experience designing, executing, and launching clinical diagnostic products.
Strong product-development experience in general clinical chemistry, immunoassay, or similar product formulations.
Experience writing research study protocols, reports, and SOPs, with strong presentation skills for senior management, review boards, and peers.
Strong communication and critical-thinking skills, a growth mindset, and eagerness to solve problems in a dynamic product-development environment.
Solid experience with design of experiments, advanced statistical methods, Lean practices, and structured problem solving.
Strong understanding of national and international quality-system requirements, especially design control.
Nice to have
PhD in an associated field.
Culture & Benefits
Collaborative teams working across the globe, with leadership support for career development and opportunities to drive visible change.
Medical plans, HSA funds, fertility support, life and disability coverage, and paid parental leave.
401(k) with profit sharing, employee stock purchase program, paid time off, and pet insurance.
Mental-health platform, learning and development opportunities, education benefits, student-debt relief, wellness support, and Employee Resource Groups.
Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer and welcomes candidates from diverse backgrounds.
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