Staff Scientist, Product Development

Description

The estimated salary range for this role based in California is between $135,900 and $177,200 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieuxs bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidates experience and will be presented in writing at the time of the offer.

In addition, bioMrieux offers a competitive Total Rewards package that may include:

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

Position Summary

Specific Diagnostics, a BioMrieux company, is a medical device company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST results directly from positive blood cultures. BioMrieuxs mission is to provide innovative and reliable medical devices that improve patient outcomes and enhance the life of people around the world. Our team of highly skilled professionals strives excellence in research, development, and manufacturing.

As aStaff Scientistin theMicrobiology Department, you play a crucial role in supporting the development of ASTproducts. Your responsibilities span bothlaboratory workandcollaboration with R&D teams and other functionsto ensure seamless integration of AST assays on theVitek Reveal platform . You will contribute to the development of concepts, tools, methods, plans , protocols and reports to support the development of diagnostic tests under design control. Strong communication, organizational, and troubleshooting skills are essential, along with the ability to work bothindependentlyandcollaboratively.

Primary 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, 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.

Knowledge and Skills

• M.S. with 8+ years or PhD with 5+ yearsrelevant 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).
• 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 thrive in challenging fast-paced multidisciplinary environment with 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 product at the top of their mind when forming decisions. Lead by example and reinforcing corporate values that lead to the success of the department.