R&D Senior Scientist

As the R&D Senior Scientist, you will drive, develop, and support the development of innovative quality control products through robust design control and life cycle management processes offering opportunities to routinely collaborate with other Scientists, Project Management, Manufacturing Engineering, Marketing, Regulatory Affairs, and other functional groups. As key technical contributors and innovators, our R&D Scientists are committed to the expansion and support of Bio-Rad's quality control product lines and specific to this role, the VIROTROL quality controls for infectious disease.

Location: This position must be based in Irvine, California and requires the employee to be located within commuting distance of the office.

• Bio-Rad is seeking an innovative and enthusiastic Research and Development Senior Scientist who's role is to:
• Advance new and existing infectious disease and core quality control products.
• Ensure integrity of state-of-the-art in vitro diagnostics QC products by designing and executing effective experiments, championing design verification and validation plans, reviewing design input requirements, and ensuring development design control goals are met, completed, and within budget.
• Influence critical design decisions with design verification data that clearly communicate data, observations, and results. Facilitate scientific advancement with failure analysis efforts (basic experiment planning, execution, documentation, and reporting) and by coordinating the development of test tools to simulate errors and faults and acquire objective outputs.
• Plan and execute studies, perform laboratory testing and experiments, apply critical thinking and investigative reasoning, and work independently or collaboratively to develop products that support the organization's growth objectives.
• Lead by example and recognizing opportunities to mentor.
• Communicate effectively with leadership and project management.

• Preferred:
  PhD in Biology, Biochemistry, Microbiology or closely related discipline with experience in a technical related field.
• Minimum:
  Bachelor's degree in life science or related technical discipline.
• Eight (8) years' industry experience working in an FDA-regulated environment, preferably IVDs.
• Works with potentially infectious human pathogens in controlled laboratory conditions.
• Performs serological and/or molecular test methods for the detection of infectious disease. Practical working knowledge of the various lateral flow, EIA, ddPCR, NAT, methodologies, associated manual and automated testing platforms utilized for infectious disease testing in clinical and blood donor screening centers a plus .
• Able to follow instructions with desire and willingness to perform moderately complex laboratory studies. Works effectively in groups and/or independently where tact and collaborative efforts prevail.
• Aptitude for writing clear plans, reports, and SOPs and presenting your progress to colleagues and senior management.
• Strong communication and critical thinking skills with a growth mindset and eagerness to problem-solve in a dynamic environment.
• Excellent planning and organizational skills; ability to critically review and summarize data a must.
• Practical working knowledge of Quality Systems Regulations (QSR), Good Manufacturing Practices (GMP), Design Control / Design for Six Sigma and ISO 13485 standards. Experience with Domestic and European regulations (FDA, CE Mark, MDSAP etc.) a plus.
• Posses solid experience with Design of Experiments, statistical methods, Lean Practices and structured problem solving.

At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.

We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt…