Sr. Staff Scientist - AST

About the role

Act as technical and scientific expert in the design and development of high-quality products on time, within budget, and with a high degree of customer satisfaction. Acts as an expert for new product development or current product improvement projects. Acts as an expert for AST investigations.

Primary Duties

• Lead VITEK 2 AST drug round development projects.
• Participate in VITEK 2 AST investigations.
• Collaborate closely with the software, hardware development and system engineering teams.
• Contribute to the development of tools for analyzing large performance data sets generated from (AST/ID/molecular) experiments.
• Acts as expert for all biological testing needed for assay development and system verification activities.
• Troubleshoot technical issues specific to the (AST/ID/Molecular Biology) tests/system, record and report these issues cross-functionally, and provide suggestions and resolutions for investigations.
• Lead 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, technical design reviews and critically evaluate design and implementation plans, can act independent reviewer.
• Summarize findings and present results to cross-functional teams.
• Mentor and train new and existing team members and be a technical advisor for data analysis problems.
• Act as SME for audits, interaction with FDA and other authorities, and key opinion leaders.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

• Required Education, Training and Experience: Bachelor's degree required in Medical Technology, Life Sciences, Biomedical, Microbiology, or related science field. 4 years of additional relevant experience, defined below, will be accepted in lieu of a bachelor's degree. 10+ years of professional related experience with VITEK 2 drug development (including CLSI reference methods) participation in VITEK 2 AST investigations.
• Preferred Education, Training And Experience: Advanced degree (MS, PHD) preferred. Experience in product development in regulated environment. Advanced skills necessary for good laboratory safety, aseptic technique, and basic Microbiology/Molecular technique.

Knowledge, Skills, And Abilities (KSAs)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Comfortable giving clear, direct, and actionable feedback.
• Demonstrates assertiveness and confidence in the face of a challenge.
• Written Communications – including the ability to communicate technical data in written form. Informing others by sharing clear, timely information to ensure alignment.
• Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel.

Working Conditions & Physical Requirements (Summary)

• Ability to remain in a stationary position for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and similar structures.
• Ability to wear PPE correctly most of the day.
• No operation of heavy machinery required.
• No requirement to move objects up to 50 pounds.

Pay

The estimated salary range for this role is between $140,000-$180,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program.

Schedule

This role is lab-based and follows work practices for working with laboratory biohazards and chemical hazards. The estimated salary range for this role is between $140,000-$180,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program.