Scientist I

Description

This position is part of a team that supports the analytical studies for regulatory submissions of in vitro diagnostic (IVD) products developed by BioFire Diagnostics. 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. 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 BioFire or by external contractors.

Essential Job Duties and Responsibilities

1. Performs all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. 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.
3. 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.
4. May directly supervise and/or manage one or more research associates with an emphasis on proper training and work practices, efficiency, integrity, safety, collegiality, teamwork, respect, and innovation.
5. Supports an atmosphere of inclusion and collective contribution to projects and procedures.
6. Provides guidance for team member’s professional development and conducts performance appraisals with appropriate follow-up action.
7. Develops project timelines, determines resource needs, and contributes to budgeting for validation of IVD reagent test kits.
8. Writes study plans and study protocols that include detailed descriptions of methodology and provide acceptance criteria that succinctly summarize the required study results.
9. 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.
10. Seeks to improve procedures and methods for efficiency, accuracy, and reliability.
11. Ensures that laboratory and study activities are conducted according to approved study protocols, Standard Operating Procedures (SOPs), and Work Instruction Documents (WIDs).
12. Ensures notebooks and documentation for assigned projects and experiments are maintained in accordance with BioFire’s Employment Handbook and Standard Operating Procedures.
13. Communicates regularly with direct supervisor to relay project status and data summaries, technical topics or challenges, and personnel matters.
14. Advises management about scientific issues related to studies in support of regulatory submissions.
15. Compiles and presents study results and/or research and contributes to group discussions, presentations, meetings, conferences, manuscripts, grant proposals, and patent applications, as needed.
16. Writes detailed study reports following general guidelines and formats that have been established as effective means of communication to the appropriate regulatory entities.
17. Contributes to the development, writing, and technical review of regulatory documents for submission to the FDA and other regulatory bodies (includes pre-submission documents, registration applications and product instructions for use).
18. Stays current with knowledge of regulatory requirements, guidelines, and expectations for establishing performance of diagnostic products and maintains broad knowledge of state-of-the-art principles and theories.
19. Performs other duties as assigned.

Supplemental Data

None.

Qualifications

Training and Education

requires a PhD with no additional experience or a Master's degree with at least 5 years relevant industry experience. 

Experience

Molecular biology (PCR) and/or microbiology laboratory experience required. Supervision and management experience in professional setting preferred.

Knowledge, Skills and Abilities

Strong written and oral communication and data analysis skills. Basic statistical techniques. Must be adaptable and able to work collaboratively and to tight timelines.

Physical Requirements

May be required to lift 30 lbs.