R&D Senior Scientist

Bio-Rad Laboratories•Irvine, CA

2d•Onsite

About The Position

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. 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.

Requirements

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.
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.

Nice To Haves

PhD in Biology, Biochemistry, Microbiology or closely related discipline with experience in a technical related field.
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 .
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.

Responsibilities

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.