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Description

This position is part of a team that supports the analytical studies for regulatory submissions of in vitro diagnostic (IVD) products developed by bioMérieux. The primary responsibility for Scientist I is to develop, lead, and report on performance studies that demonstrate products and devices are functioning in accordance with design and regulatory requirements and specifications.

Under the supervision of the Associate Director/Director of IVD Device Validation, the Scientist I is responsible for planning and designing projects, directing and overseeing laboratory activities of research associates, data analysis, troubleshooting, reporting results and observations, and writing and reviewing study reports and regulatory submission documents. Study activities supervised by the Scientist I may be conducted at bioMérieux or by external contractors.

Job Responsibilities

• Uses professional concepts to contribute to the development and embodiment of company values and principles and to achieve personal, team, department, and company objectives in creative and effective ways. 
• Collaborates with other scientists and personnel in various company departments to develop strategies and experiments, share resources, communicate progress and observations, problem-solve, and resolve technical issues.  
• May directly supervises and/or manages one or more research associates with an emphasis on proper training and work practices, efficiency, integrity, safety, collegiality, teamwork, respect, and innovation. 
• Supports an atmosphere of inclusion and collective contribution to projects and procedures.  
• Provides guidance for team member’s professional development and conducts performance appraisals with appropriate follow-up action. 
• Develops project timelines, determines resource needs, and contributes to budgeting for validation of IVD reagent test kits. 
• Writes study plans and study protocols that include detailed descriptions of methodology and provide acceptance criteria that succinctly summarize the required study results.  
• Oversees the execution of study protocols, data evaluation, and data verification to ensure that the study is conducted and reported appropriately and to help the team identify, communicate, and resolve technical issues.
• Seeks to improve procedures and methods for efficiency, accuracy, and reliability.   
• Ensures that laboratory and study activities are conducted according to approved study protocols, Standard Operating Procedures (SOPs), and Work Instruction Documents (WIDs). 
•  Ensures notebooks and documentation for assigned projects and experiments are maintained in accordance with BioMerieux's Employment Handbook and Standard Operating Procedures. 
• Communicates regularly with direct supervisor to relay project status and data summaries, technical topics or challenges, and personnel matters.
• Advises management about scientific issues related to studies in support of regulatory submissions. 

Job Qualifications

• Requires a PhD in scientific discipline, Life Science including Biology, Microbiology, Biochemistry, etc. preferred. 
  • May also include exceptional candidates with a Master’s degree and at least 5 years of relevant industry experience.
• Molecular biology and/or microbiology laboratory experience required. 
• Supervision and management experience in professional setting preferred.
• Strong written and oral communication and data analysis skills. Basic statistical techniques. Must be adaptable and able to work collaboratively and to tight timelines.

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).