Position Summary
This position is part of a team responsible for performance assessment and validation of molecular in vitro diagnostic products. The Research Associate 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 proficiency in laboratory technical and organizational skills, attention to detail, critical thinking, troubleshooting, and problem-solving, data analysis, sequence analysis, and a dedication to the mission and goals of the department and BioFire. A Research Associate II will normally self-direct on routine work and will operate with general or detailed instruction and supervision on new procedures and assignments.
This is a non-exempt full-time on-site laboratory-centric position.
Primary Duties:
- Perform all work in compliance with company policy and within the guidelines of BioFire’s Quality System.
- Assist with stocking project-specific laboratory supplies, including inventorying stock.
- 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.
- 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.
- 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.
- 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.
- Perform routine and complex calculations and lab techniques including solution formulation, microbial culture and enumeration, nucleic acid extraction and quantification, digital PCR and/or sequencing, primer/sequence evaluation using bioinformatic tools, as well as basic statistical analyses.
- Execute study protocols and contribute to protocol and process development, optimization, and/or revision.
- Conduct routine data analysis with minimal supervision and deduce next steps.
- Communicate data and analyses in written reports and oral presentations to peers and supervisors, commensurate with job level.
- Contribute to the writing of study reports.
- Train other team members on laboratory and department practices and procedures, commensurate with experience.
- Develops strategies to troubleshoot unexpected experimental results and/or product performance and proposes solutions.
- Perform other duties as assigned.
Qualifications
Training and Education
- Requires a Bachelor’s degree in a scientific discipline.
Experience
- A minimum of two years’ experience in an academic, industry, or healthcare laboratory
- Experience with real-time PCR and/or sequence analysis and/or microbiology techniques
- Familiarity with Biosafety Level 2 practices
Knowledge, Skills, and Abilities
- Has solid working knowledge of current and evolving microbiology and molecular biology principles, tools, and techniques relevant to developing diagnostic tests for infectious diseases
- Detail-oriented in executing work and in record keeping
- Strong oral and written communication skills
- Proficiency in laboratory practices including pipetting, handling biological and chemical materials, sterile technique and contamination control, and routine concentration and statistical calculations
- Proficiency with Microsoft Office (Outlook, Excel, PowerPoint, and Word)
- Ability to work in a dynamic environment where priorities sometimes change on short notice
- Ability to follow rules and regulations
- Demonstrated critical thinking and problem-solving skills
Physical Requirements
- Ability to remain in stationary position, often standing, for prolonged periods.
- Ability to ascend/descend stairs, ladders, ramps, and the like.
- Ability to wear PPE correctly most of the day.
- Ability to operate heavy machinery.
- Ability to adjust or move objects up to 50 pounds in all directions.
