Staff Scientist, Product Development

Description

As a Staff Scientist in the Microbiology Department, you play a crucial role in supporting the development of AST products. Your responsibilities span both laboratory work and collaboration with software and system engineering teams to ensure seamless integration of AST assays on the Vitek Reveal platform. You contribute to building and documenting tools, ensuring precise and dependable AST assay results to guide patient therapy. Strong communication, organizational, and troubleshooting skills are essential, along with the ability to work both independently and collaboratively.

Duties:

• Collaborate closely with the software, system engineering, and chemistry teams, as well as other functions, to support menu products on the Vitek Reveal.
• Design and execute development and verification studies required to support AST assay development
• Analyze large performance datasets generated from AST experiments.
• Support biological testing needed for software validation and system verification activities.
• Troubleshoot technical issues specific to the AST tests/system, record and report these issues cross-functionally, and provide suggestions and resolutions for investigations.
• Prepare bacterial cultures and perform AST experiments using clinical bacterial isolates.
• Collaborate with other scientists and managers to optimize testing protocols and workflows within the lab.
• Maintain accurate records of experiments and results, write work instructions (WIs), standard operating procedures (SOPs), protocols, reports, process flows, etc.
• Ensure compliance with regulatory standards (e.g., FDA, ISO) and comply with biohazard safety standards.
• Participate in product risk assessment, and technical design reviews and critically evaluate design and implementation plans
• Summarize findings and present results to cross-functional teams.
• Mentor and train new and existing team members
• Propose and explore novel approaches/tools to develop new methods and enhance testing accuracy and efficiency.

Qualifications:

• M.S. with 8+ years or PhD with 5+ years relevant experience in Microbiology, Bioengineering, or related field
• Demonstrated proficiency in AST methods (broth microdilution, disk diffusion, etc.) desirable.
• Familiarity with bacterial identification systems (MALDI-TOF, PCR).
• Understanding of regulatory and compliance requirements for IVD products (e.g., QSR, ISO, GLP).
• Programming skills (Python, R, or similar) for data analysis
• Familiarity with data visualization/analysis software such as Tableau, JMP, or Minitab. Strong proficiency in the use of MS Office suite
• Excellent communication (verbal and written) abilities and collaboration skills.
• Strong organizational skills, decision-making, communication, teamwork, and troubleshooting skills.
• Ability to thrive in challenging fast-paced multidisciplinary environments with a focus on meeting tight deadlines and delivering high-quality results.
• Ability to work both independently with minimal guidance or oversight as well as in tandem with all levels of corporate personnel.
• Make sound, well-informed judgments with the quality of the product at the top of their mind when forming decisions. Lead by example and reinforce corporate values that lead to the success of the department.