bioMérieux is a pioneering force in the medical microbiology device industry. Our cutting-edge technologies have been transforming healthcare and improving patient outcomes. The Associate Staff Scientist will play a critical role in the development and optimization of antimicrobial susceptibility tests. You will be responsible for designing, documenting, and executing experiments, analyzing data and collaborating with cross-functional teams to ensure successful product development, verification, validation and commercialization. You will also be expected to perform root cause analysis for issues that arise during data collection, development, and commercialization, as needed. You will work in cross-functional teams to ensure that the studies performed meet all necessary regulatory and quality standards for in vitro diagnostic (IVD) products. You will contribute to the advancement of our diagnostic platform portfolio, leveraging your expertise in microbiology and system integration and product development under Design Control. Primary Duties: + Manage and participate in projects relating to the design and development of antimicrobial susceptibility testing assays and sample preparation methods for the optimization and production of novel antibiotic susceptibility tests, ensuring adherence to project timelines and milestones. + Design and implement experiments to evaluate the performance and robustness of the diagnostic test including data collection for algorithm optimization, feasibility, assay optimization, verification and validation. Daily data monitoring and data analysis using statistical tools and interpreting results to drive decision-making and further system optimization. + Collaborate with other teams and departments within Research and Development, Quality, Regulatory, Marketing, Operations and Supply Chain/Procurement to align product development efforts and ensure compliance with regulatory requirements + Prepare and review technical documentation including protocols, reports, and specifications to support product development and regulatory submissions and prepare presentations or white papers as needed by team or management to upper management. + Identify technical challenges and proactively develop solutions to overcome obstacles in product development + Perform other duties and projects related to lab and department operations as requested by management. Minimum Qualifications: + B.S. with 5+ years relevant experience in Biochemistry, Chemistry, Microbiology, and/ or Medical Diagnostic. + OR M.S. with 4+ years + OR PHD with 1+ relevant industry experience + A strong background in antimicrobial susceptibility testing is highly desirable. + Experience working within a fast-paced environment with strong background in product development preferably in the field of diagnostics and proven proficiency in data analysis, study design, troubleshooting and root cause analysis to resolution. + Experience with analysis of large performance data sets generated from AST experiments and Experience with JMP or other statistical software are highly desirable. + Experience in design development, and design output transfer processes. + Experience with the development and validation of clinical diagnostic and susceptibility assays for infectious diseases. + Need to be comfortable working with a variety of materials, technologies, and procedures, as well as staying up to date on competition and developments relative to the industry. + Strong organizational skills, decision making, communication, teamwork, and troubleshooting skills. + Must be able to work both independently with minimal guidance and oversight as well as in tandem with all levels of corporate personnel. Show understanding, tact, and patience when working with diverse team members to maintain positive working relationships throughout the company. + Make sound, well-informed judgments with the quality of product at the top of their mind when forming decisions. Lead by example and reinforcing corporate values that lead to the department's success. + Clinical microbiology laboratory experience is highly desirable. + Experience working in a regulated environment, Knowledge of ISO 13485 and FDA Quality System Regulations is highly desirable. 10% Domestic travel required and potential for International Travel The estimated salary range for this role based in California is between $120,000 - 134,600. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. In addition, bioMérieux offers a competitive Total Rewards package that may include: · A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options · Company-Provided Life and Accidental Death Insurance · Short and Long-Term Disability Insurance · Retirement Plan including a generous non-discretionary employer contribution and employer match. · Adoption Assistance · Wellness Programs · Employee Assistance Program · Commuter Benefits · Various voluntary benefit offerings · Discount programs · Parental leaves