Sr Staff Scientist – AST

Local Position Summary

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

1. Lead VITEK 2 AST drug round development projects.

2. Participate in VITEK 2 AST investigations.

3. Collaborate closely with the software, hardware development and system engineering teams.

4. Contribute to the development of tools for analyzing large performance data sets generated from (AST/ID/molecular) experiments.

5. Acts as expert for all biological testing needed for assay development and system verification activities.

6. 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.

7. Lead other scientists and managers to optimize testing protocols and workflows within the lab.

8. Maintain accurate records of experiments and results, write work instructions (WIs), standard operating procedures (SOPs), protocols, reports, process flows etc...

9. Ensure compliance with regulatory standards (e.g., FDA, ISO) and comply with biohazard safety standards.

10. Participate in product risk assessment, technical design reviews and critically evaluate design and implementation plans, can act independent reviewer.

11. Summarize findings and present results to cross-functional teams.

12. Mentor and train new and existing team members and be a technical advisor for data analysis problems.

13. Act as SME for audits, interaction with FDA and other authorities, and key opinion leaders.

14. Perform all work in compliance with company quality procedures and standards.

15. 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.
• Education Substitution: In lieu of a bachelor's degree, 4 years of additional relevant experience, defined below, will be accepted.
• 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. 

Supervisory Responsibilities 

No direct or indirect supervisory responsibilities. Makes operational and tactical decisions with short‑term impact and strategic decisions with long‑term impact, both with little‑to‑no supervisory review.

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. Domestic travel: 5%. International travel: 5%. Total travel: 10%. Position is lab-based and follows work practices for working with laboratory biohazards and chemical hazards.