Scientist, Analytical Development

This is a 6-month contract, 40 hours a week on-site and is project based.

What You'll Do

• Test, validate, and characterize new product designs using both spectral and conventional flow cytometers across multiple platforms.
• Develop, optimize, and transfer protocols for sample preparation, staining, acquisition, and data analysis to ensure accurate and reproducible results.
• Perform QC testing, analyze flow cytometry data using software such as FlowJo, and ensure results meet established specifications and acceptance criteria.
• Plan and execute verification and validation and stability studies, including accelerated stability studies, data analysis, and technical reporting.
• Support QMS and design control activities, including controlled documentation, deviations, investigations, CAPA, change control, and design reviews.
• Perform instrument maintenance, calibration, troubleshooting, and performance verification across multiple flow cytometry platforms.
• Investigate product performance issues and complaints and support root cause analysis and corrective actions.
• Develop SOPs and support method transfer from R&D into production.
• Conduct product testing, demonstrations, and technical evaluations at local flow cytometry core facilities and customer and partner sites, with travel as needed.
• Maintain compliance with laboratory safety, ISO 9001, GMP, and applicable quality requirements.
• Other duties as assigned.

What You'll Bring

• Strong expertise in multiparameter (10+ color) flow cytometry analysis, compensation, and gating strategies for analysis of mixed cell populations.
• Experience analyzing flow cytometry data in software such as FlowJo.
• Experience with QC testing and QMS processes in a regulated or quality focused environment.
• Strong understanding of stability principles, including shelf life determination and accelerated stability testing.
• Good knowledge of laboratory health and safety standards, including working with blood products such as leukopaks.
• Excellent analytical and research skills.
• Attention to detail and excellent communication skills and systems in record keeping and documentation.
• Demonstrated ability to independently lead technical projects and resolve complex scientific problems.