Senior Reagent & Assay Scientist, Flow Cytometry

Millenniumsoft; San Diego (CA); On-site; USD 63,000 - 89,000; Full time

Job summary

Medical Devices Company seeks a Scientist III in San Diego to sustain and improve reagent and assay products across their lifecycle. The role involves reviewing and authoring technical files, coordinating with cross-functional teams, and ensuring regulatory readiness and inspection preparedness.

The candidate should have a life sciences degree, 5+ years of relevant R&D experience, and strong knowledge in immunology and flow cytometry, with excellent communication skills to liaise across QA,

Qualifications

• Minimum of bachelor’s degree in Life Science.
• Minimum 5 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
• Strong understanding of immunology, flow cytometry, assay development or related cell-based research technologies.
• Experience authoring and reviewing technical documentation.
• Demonstrated ability to lead projects independently and collaborate effectively across functions.
• Excellent written and verbal communication skills.

Responsibilities

• Support reagent and assay sustainment projects for marketed products.
• Review and approve technical documentation to support reagent and assay products.
• Review design history files, validation reports, risk assessments, technical files, and product specifications to ensure completeness and compliance.
• Ensure documentation aligns with applicable quality system requirements and regulatory expectations.
• Support change control activities and assess the impact of proposed product, process, or documentation changes.
• Serve as a technical subject matter expert during internal and external audits.
• Support preparation of audit readiness activities and ensure technical documentation is inspection-ready.
• Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operation teams to support business objectives.

Skills

Lead projects independently

Written and verbal communication

Education

Bachelor's degree in Life Science

Job description

Medical Devices Company seeks a Scientist III in San Diego to sustain and improve reagent and assay products across their lifecycle. The role involves reviewing and authoring technical files, coordinating with cross-functional teams, and ensuring regulatory readiness and inspection preparedness.

The candidate should have a life sciences degree, 5+ years of relevant R&D experience, and strong knowledge in immunology and flow cytometry, with excellent communication skills to liaise across QA,