Associate Staff Scientist
Description
- 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.
- 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.
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