Research Associate II
Description
Position Summary
The Research Associate II position supports the performance assessment and validation of molecular in vitro diagnostic products within the Clinical Affairs Lab Operations team. This role contributes to regulatory submissions (e.g., FDA and global agencies) by executing molecular and microbiological experiments such as PCR, nucleic acid extraction, and microbial culture. The associate ensures data integrity through accurate collection, analysis, and documentation in compliance with protocols and safety standards. Operating in a collaborative, fast-paced environment, the role requires technical proficiency, critical thinking, and effective communication to support the department’s mission and bioMérieux’s goals. Responsible for creating, optimizing ,developing, updating and sustaining diagnostic assays and reagents in a regulated environment, while driving innovative solutions. Design and develop new biomolecules or reagents, collect and manage biological samples to support method/product development. Identify emerging technologies and trends related to diagnostics. Provide technical assistance to support existing products, methods or techniques. Performs analytical verifications and documenting validation activities and outcomes for regulatory submissions.
Primary Duties
2. Ensures data integrity by collecting, recording, analyzing, and verifying experimental data in compliance with protocols and regulatory standards.
3. Executes study protocols and contributes to their development, optimization, and revision.
4. Conducts routine and complex calculations and laboratory techniques, including solution formulation and microbial enumeration.
5. Analyzes data with minimal supervision and determines appropriate next steps.
6. Communicates findings through written reports and oral presentations to peers and supervisors.
7. Contributes to the writing of study reports for internal and regulatory use.
8. Coordinates with team members and cross-functional groups for lab activities, equipment use, and project execution.
9. Maintains laboratory equipment, supplies, and workspaces according to safety and quality standards.
10. Trains other team members on lab practices and departmental procedures, as appropriate.
11. Develops troubleshooting strategies for unexpected experimental results and proposes solutions.
12. Operates in a Biosafety Level 2/2+ environment, handling pathogenic microbes and human specimens using sterile techniques.
13. Assists with inventory management and stocking of project-specific laboratory supplies.
14. Performs all work in compliance with corporate policies and the Quality Management System.
Scope and Resources Accountability
The Research Associate II is an individual contributor with no direct or indirect supervisory responsibilities. The role operates within the Clinical Affairs Lab Operations team and is accountable for executing laboratory experiments, maintaining data integrity, and supporting regulatory submissions. The position requires coordination across functional groups and contributes to protocol development and troubleshooting, impacting the quality and timeliness of diagnostic product validation.
Key Performance Indicators (KPIs)
Accuracy and completeness of data recorded in lab notebooks and reports
Timely execution of study protocols and experiments
Compliance with safety, quality, and regulatory standards
Successful contribution to regulatory submissions (e.g., FDA)
Effective collaboration and communication within and across teams
Number of protocols executed or optimized
Training effectiveness for new team members
Qualifications
Education and Training
Bachelor’s degree in a scientific discipline
Minimum of two years of experience in an academic, industry, or healthcare laboratory setting.
Real-time PCR
Sequence analysis
Microbiology techniques
Familiarity with Biosafety Level 2 practices
Knowledge, Skills, and Abilities
The role is primarily technical and scientific in nature, focused on laboratory work, data analysis, and regulatory support. There are no specific business strategy, financial, or market-facing responsibilities that require business acumen or understanding of broader business operations.
Develops strategies to troubleshoot unexpected experimental results and proposes innovative solutions.
Contributes to protocol and process development, optimization, and revision.
Demonstrates critical thinking and problem-solving skills to improve experimental design and product performance.
Evaluates primers and sequences using bioinformatic tools to support assay development.
Comfortable working in a dynamic environment where priorities may shift, requiring adaptability and creative thinking.
Detail-oriented in executing laboratory procedures and maintaining accurate records.
Ability to follow rules and regulations, including protocols, SOPs, and safety guidelines.
Proficiency in laboratory practices, such as sterile technique, pipetting, and contamination control.
Comfortable working in a dynamic environment with shifting priorities, requiring sustained attention and adaptability.
Strong organizational skills to manage multiple tasks and maintain consistency in data collection and analysis.
Ability to remain in a stationary position (often standing) for prolonged periods, supporting physical focus during lab work.
Strong organizational skills to manage multiple tasks, experiments, and documentation efficiently.
Proficiency in inventory management, including stocking and tracking project-specific laboratory supplies.
Ability to maintain laboratory equipment, supplies, and workspaces in accordance with operational, safety, and quality standards.
Detail-oriented record keeping, including accurate data entry in electronic lab notebooks and study worksheets.
Ability to follow structured protocols and standard operating procedures to ensure consistency and compliance.
Comfortable working in a dynamic environment, requiring prioritization and time management.
Trains other team members on laboratory and departmental practices and procedures, commensurate with experience.
Coordinates and collaborates within and across teams and functional groups for routine lab activities, equipment use, and project execution.
Shares knowledge, skills, and ideas to support team development and collective success.
Maintains laboratory equipment, supplies, and workspaces according to operational, safety, and quality standards.
Ensures data integrity through accurate collection, analysis, and documentation of experimental results.
Executes study protocols and contributes to their development, optimization, and revision.
Performs routine and complex lab techniques with minimal supervision, demonstrating independence in managing assigned tasks.
Comfortable working in a dynamic environment, managing shifting priorities and timelines effectively.
Demonstrated critical thinking and problem-solving skills to interpret experimental results and troubleshoot issues.
Develops strategies to address unexpected experimental outcomes and proposes scientifically sound solutions.
Comfortable working with biosafety level 2/2+ pathogens and human specimens, requiring careful risk assessment and adherence to safety protocols.
Ability to work independently on routine tasks and with general supervision on new or complex procedures.
Proficiency in data analysis and bioinformatics tools to evaluate sequences and interpret molecular biology results.
Adaptability in a dynamic environment, managing shifting priorities and complex workflows.
Communicates and coordinates effectively and respectfully with peers and supervisors across teams and functional groups.
Collaborates within and across departments, demonstrating awareness of team dynamics and shared goals.
Acts as a good lab citizen, contributing to a positive and productive work environment.
Understands and adheres to company policies, quality systems, and regulatory requirements, reflecting alignment with organizational standards and expectations.
Communicating Effectively
Strong oral and written communication skills for presenting data, writing reports, and collaborating with peers and supervisors.
Ability to communicate data and analyses clearly in written reports and oral presentations.
Collaborates respectfully and effectively within and across teams and functional groups.
Shares knowledge, skills, and ideas to support team learning and cohesion.
Comfortable using Microsoft Office tools (Outlook, Excel, PowerPoint, Word) to support communication and documentation.
Relating Skills
Collaborates effectively within and across teams and functional groups.
Communicates respectfully with peers and supervisors to support a positive and productive work environment.
Acts as a good lab citizen, demonstrating teamwork, accountability, and shared responsibility.
Shares knowledge, skills, and ideas to foster learning and cooperation among team members.
Trains other team members on laboratory and departmental practices, contributing to team development.
Trains other team members on laboratory and departmental practices and procedures, commensurate with experience.
Shares knowledge, skills, and ideas to support team learning and development.
Acts as a collaborative team member, contributing to a positive and inclusive lab environment that encourages growth and knowledge exchange.
Collaborates effectively across teams and functional groups, demonstrating adaptability in working with individuals from various scientific and operational backgrounds.
Communicates respectfully and professionally with peers and supervisors to maintain productive working relationships.
Shares knowledge and skills to support team learning and cross-functional coordination.
Operates within a regulated environment, requiring interaction with internal stakeholders such as Quality Assurance, Regulatory Affairs, and R&D.
Acting with Honor and Being Open
Demonstrates integrity and accountability by ensuring data accuracy and compliance with protocols, SOPs, and regulatory standards.
Follows company policies and quality management guidelines, reflecting ethical conduct and transparency in work practices.
Communicates respectfully and professionally with peers and supervisors, fostering a culture of openness and trust.
Comfortable working with human specimens and biosafety level 2 pathogens, requiring adherence to safety and ethical standards.
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