Scientist II, Reagent & Assay Development (Flow Cytometry)

MillenniumSoft Inc; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

MillenniumSoft Inc. seeks a Scientist II in Reagent and Assay Development to sustain and improve reagent products across their lifecycle, integrating assays and flow cytometry instruments to advance next-gen research and clinical platforms.

The role collaborates with Regulatory, Quality, Marketing, Manufacturing, Medical Affairs and Operations to meet business objectives and requires a bachelor’s degree in Life Science with 2+ years in immunology/flow cytometry and strong documentation skills.

Qualifications

• Bachelor's degree in Life Science is required.
• Minimum 2 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/bi 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 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.
• Provide technical support 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

Immunology

Flow cytometry

Assay development

Technical documentation

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree in Life Science

Job description

MillenniumSoft Inc. seeks a Scientist II in Reagent and Assay Development to sustain and improve reagent products across their lifecycle, integrating assays and flow cytometry instruments to advance next-gen research and clinical platforms.

The role collaborates with Regulatory, Quality, Marketing, Manufacturing, Medical Affairs and Operations to meet business objectives and requires a bachelor’s degree in Life Science with 2+ years in immunology/flow cytometry and strong documentation skills.