Associate Staff Scientist

Description

Department: Microbiology
Reports To: Associate Director R&D Microbiology

As an Associate Staff Scientist in the Microbiology Department, you will play a key role in the development of innovative Antimicrobial Susceptibility Testing (AST) products for the VITEK REVEAL platform. Leveraging your scientific expertise, you will independently design, execute, and analyze laboratory studies that support assay development, optimization, verification, and validation activities. You will contribute to the design and development of high-quality products on time, within budget, and with a high degree of customer satisfaction.

You may act as a team leader for new product development or current product improvement projects.

This role combines hands-on laboratory investigation with collaboration across multidisciplinary teams, including software and systems engineering, manufacturing, quality, regulatory, and product development functions, to support the successful development and integration of AST assays on the VITEK REVEAL platform. You will generate and analyze complex microbiological datasets, apply statistical methods to evaluate assay performance, and communicate findings that support data-driven product decisions.

In addition, you will contribute to the development, validation, and documentation of scientific methods, tools, and processes that support efficient and compliant product development.

Success in this role requires strong scientific problem-solving abilities, data analysis skills, effective communication, and the ability to work independently while contributing effectively within cross-functional teams.

• Collaborate closely with software, hardware development, systems engineering, quality, manufacturing, and other cross-functional teams to support development and integration of AST products on the VITEK REVEAL platform.
• Contribute to the development, validation, and continuous improvement of tools and methodologies for analyzing large and complex performance datasets generated from AST studies and product development activities.
• Design, execute, and support biological testing activities required for assay development, system characterization, design verification, validation, and lifecycle management.
• Perform advanced analysis and interpretation of experimental data, identify trends, investigate anomalies, and provide data-driven recommendations to support technical and project decisions.
• Troubleshoot technical issues related to AST assays, system performance, and laboratory workflows; document findings, communicate risks, and support cross-functional investigations and corrective actions.
• Perform laboratory activities in accordance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), established procedures, and applicable quality system requirements.
• Collaborate with scientists, engineers, and project teams to optimize testing protocols, workflows, assay performance, and laboratory efficiency.
• Develop, review, and maintain technical documentation including work instructions (WIs), standard operating procedures (SOPs), protocols, test methods, study plans, reports, process flows, and other design control deliverables.
• Ensure compliance with applicable regulatory requirements, quality standards, biosafety procedures, and laboratory safety practices, including FDA, ISO 13485, CLSI, and internal quality system requirements.
• Participate in product risk assessments, technical design reviews, root cause investigations, and design control activities; critically evaluate technical approaches and provide scientific recommendations.
• Support transfer, implementation, and standardization of laboratory methods, testing procedures, and best practices across development activities.
• Summarize complex technical findings and present results, recommendations, and project updates to cross-functional teams and management.
• Serve as a technical resource for microbiology, AST, and data analysis activities; provide guidance, training, and mentoring to new and existing team members.
• Apply statistical tools and scientific methodologies, including Design of Experiments (DOE), trend analysis, regression analysis, and process capability assessments, to support product development and continuous improvement efforts.
• Maintain knowledge of AST standards, antimicrobial resistance mechanisms, industry guidance documents, and emerging technologies relevant to…