Research Associate I/II

Description

Job Summary

The Regulatory Affairs and Clinical Affairs departments are responsible for performance assessment and validation of molecular in vitro diagnostic products for global regulatory registrations. 

The Research Associate I/II is a technical hourly position with laboratory responsibilities. The RA 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 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 I may receive general or detailed instruction and supervision on routine work, and detailed instruction and supervision on new procedures and assignments. A Research Associate II will normally self-direct on routine work with no or minimal instruction and supervision and will operate with general or detailed instruction and supervision on new procedures and assignments. 

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Follow policies and procedures and conduct oneself professionally and in accordance with the BioFire Diagnostics Employment Handbook.
3. Ensure data integrity and accurate record-keeping by collecting, recording (laboratory notebooks and study worksheets), analyzing, and verifying data in compliance with SOPs, WIDs, and Study Protocols.
4. Use and maintain laboratory equipment, supplies/inventory, and workspaces according to operational, quality control, and safety requirements, protocols, SOPs, and WIDs.
5. Perform routine or complex calculations and laboratory techniques, to include solution formulation, dilution, microbial culture and enumeration, nucleic acid extraction, real-time and/or digital PCR and sequencing, as well as graphing data, statistical analyses and primer/sequence evaluation. 
6. Work in PCR labs and a Biosafety Level 2/2(+) environment with potentially pathogenic microbes, patient samples, and body fluids using sterile technique for contamination and infection control.
7. Participates in maintenance of laboratory databases (e.g. for tracking of reagents, organism strains, samples, specimens, etc.)
8. Act as an exemplary lab citizen and team-member. Proactively coordinate, collaborate and communicate with supervisors and peers within and across teams and functional groups for lab activities, cleaning, equipment use, specific assigned tasks and projects, and sharing of knowledge, skills, and ideas.
9. Participate and contribute to protocol and process development, optimization, revision, and/or execution as well as risk or hazard identification and mitigation.
10. Train others on laboratory and departmental practices and procedures.
11. Use data and critical thinking to evaluate successful performance and/or deficiencies in products and experiments. Includes identification of patterns and trends, and critical review of results. Propose strategies and solutions when deficiencies are identified.
12. Demonstrate proficiency in time and task management, experimental design and execution, and presentation of results and outcomes (written and/or oral) to supervisors and peers.
13. Maintain an interest in current and evolving microbiology and molecular biology principles, tools and techniques. Gain a foundational understanding of infectious disease diagnostics and regulatory processes.
14. Attend and participate in all assigned meetings, including company and group meetings.
15. Attend and participate in learning and training opportunities.
16. Be curious, communicative, and committed to making ‘Cool Stuff’.

Qualifications

Training and Education

Minimum of a Bachelor’s degree with emphasis in science. Alternately, a minimum of two years of undergraduate education in a scientific discipline with at least five years of relevant laboratory experience and thorough knowledge of basic chemistry, microbiology and/or molecular biology principles.

Experience

RAI: 0-2 years experience in a laboratory setting or related biological or health care discipline.

RAII: 2-5 years of experience with laboratory techniques. Experience in molecular techniques relevant to real-time PCR and sequence analysis; microbiology training and familiarity with Biosafety Level 2 practices are a plus.

Knowledge, Skills and Abilities

Must demonstrate skill in laboratory practices (pipetting, biological and chemical material handling, sterile technique and contamination control, concentration and statistical calculations, and accurate record-keeping).

Proficiency with Microsoft Office (Outlook, Excel, PowerPoint, and Word).

Physical Requirements

Must be able to safely lift and maneuver 40lbs. Must have sufficient manual and visual dexterity for standard laboratory practices (e.g. pipetting, microcentrifuge tube capping/uncapping, syringe manipulation, etc.; reasonable accommodations are applicable). Able to wear required personal protective equipment (PPE) and work at a Biosafety Cabinet in a Biosafety Level 2/2+ laboratory environment. Must maintain regular and consistent attendance.