This position is part of a team responsible for performance assessment and validation of molecular in vitro diagnostic products.The Research Associate (RA) I/II works to meet deadlines in a dynamic environment and has the temperament to operate proactively and collaboratively in a team in support of FDA and other global regulatory submissions. Tasks will focus on molecular and microbiological experiments and procedures (e.g., nucleic acid extraction, serial dilution, PCR, bacterial and fungal culture, etc.) with associated collection, analysis, verification and recording of data in accordance with established protocols and work instruction documents, regulations, safety requirements, and the quality system. Work is primarily collaborative and requires the ability to effectively and respectfully communicate and coordinate with peers and supervisor(s). 

The position requires laboratory technical and organizational skills, attention to detail, critical thinking, troubleshooting and problem-solving, and a dedication to the mission and goals of the department and BioFire.

This is a non-exempt full-time on-site laboratory-centric position.

Essential Job Duties and Responsibilities:

1. Perform all work in compliance with company policy and within the guidelines of BioFire’s Quality System.
2. Assist with stocking project-specific laboratory supplies, including inventorying stock.
3. Act as a good lab citizen and team member. Coordinate and collaborate within and across teams and functional groups for routine lab activities, cleaning, equipment use, specific assigned tasks and projects, and sharing of knowledge, skills, and ideas.
4. Work in a Biosafety level 2/2 environment with potentially pathogenic microbes, patient samples, and body fluids using sterile technique for contamination and infection control.
5. Ensure data integrity and accurate record-keeping by collecting, recording (in an electronic laboratory notebook and/or study worksheets), analyzing and verifying data in compliance with company standard operating procedures, work instruction documents, and study protocols.
6. Use and maintain laboratory equipment, supplies/inventory, and workspaces according to operational, quality, and safety requirements as outlined in protocols, standard operating procedures, and work instruction documents.
7. Perform routine calculations and lab techniques including solution formulation, microbial culture and enumeration, nucleic acid extraction and quantification, real-time and/or digital PCR, as well as basic statistical analyses.
8. Execute study protocols and contribute to protocol and process development, optimization, and/or revision.
9. Conduct routine data analysis under supervision (RAI) or with minimal supervision and deduce next steps (RAII).
10. Communicate data and analyses in written reports and oral presentations to peers and supervisors, commensurate with job level.
11. Contribute to the writing of study reports.
12. (RAII) Train other team members on laboratory and department practices and procedures, commensurate with experience.
13. (RAII) Develops strategies to troubleshoot unexpected experimental results and/or product performance and proposes solutions.
14. Perform other duties as assigned.

Qualifications:

Education and Experience

Minimum of a Bachelor’s degree in a scientific discipline and six months (RAI) or two years (RAII) experience in an academic, industry, or healthcare laboratory.

RAII level requires experience with real-time PCR and/or sequence analysis and/or microbiology techniques and familiarity with Biosafety Level 2 practices.

Knowledge, Skills, and Abilities

1. Beginning to working knowledge of current and evolving microbiology and molecular biology principles, tools, and techniques relevant to developing diagnostic tests for infectious diseases.
2. Detail-oriented in executing work and in record keeping.
3. Strong oral and written communication skills.
4. Basic competence (RAI) or proficiency (RAII) in laboratory practices including pipetting, handling biological and chemical materials, sterile technique and contamination control, and basic concentration and statistical calculations.
5. Basic competence (RAI) or proficiency (RAII) with Microsoft Office (Outlook, Excel, PowerPoint, and Word).
6. Ability to work in a dynamic environment where priorities sometimes change on short notice.
7. Ability to follow rules and regulations.
8. Aptitude for (RAI) or demonstrated (RAII) critical thinking and problem-solving skills.

Physical Requirements

1. Must be able to safely lift and maneuver 40lbs.
2. Manual and visual dexterity to handle small tubes and manipulate very small volumes; reasonable accommodations are applicable.
3. Must be able to wear personal protective equipment, including a lab coat, disposable gloves, face mask, and safety glasses, as needed.
4. Must be comfortable working with cleaning products such as bleach.
5. Must be comfortable working with human specimens and fluids (blood, stool, sputum, etc.).
6. Must be comfortable working with biosafety level 2 pathogens.
7. Must maintain regular and consistent attendance.