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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 communicate and coordinate with peers and supervisor(s) effectively   and respectfully.

The   position requires   proficiency in   laboratory   technical skills, 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   bioM é rieux.   A Research Associate   II   will normally self-direct on routine work with no or minimal instruction and general supervision and   will operate with general or   detailed instruction and general supervision on new   procedures and   assignments.

Primary Duties:

+ Assists 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 all work in compliance with bioMérieux corporate policies and within the guidelines of the Quality Management System.

+ Perform other duties as assigned.

Education and Experience Requirements:

+ Requires a bachelor’s degree in a scientific discipline.

+ 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).

+ Comfortable working in a dynamic environment where priorities sometimes change on short notice.

+ Comfortable working with human specimens and fluids (blood, stool, sputum, etc.).

+ Comfortable working with biosafety level 2/2+ pathogens.

+ Demonstrated critical thinking and problem-solving skills.

+ Ability to follow rules and regulations.

Working Conditions and Physical Requirements:

+ Must be able to lift and safely maneuver 40lbs.

+ Manual and visual dexterity to handle small tubes and manipulate very small volumes; reasonable accommodations are applicable.

+ Must be able to wear personal protective equipment, including a lab coat, disposable gloves, face mask, and safety glasses, as needed.

+ Comfortable working with cleaning products such as bleach.