Scientist - Reagent & Assay Development, Flow Cytometry

MillenniumSoft Inc; San Diego (CA); On-site; USD 55,000 - 58,000; Full time

Job summary

MillenniumSoft Inc. in San Diego, CA, is seeking a Scientist II for Reagent and Assay Development. This 12-month contract role supports sustainment and improvement of reagent and assay products, integrating assays with flow cytometry tools to advance next‑gen research platforms.

The candidate will review documentation, participate in change control and audits, and collaborate across Regulatory, Quality, Marketing, Manufacturing, and Operations to meet objectives.

Qualifications

• Bachelor’s degree in Life Science required.
• Minimum 2 years in a research, clinical/diagnostic lab, or biotech R&D setting.
• Strong understanding of immunology, flow cytometry, and cell-based assays.
• Experience authoring and reviewing technical documentation.
• Demonstrated ability to collaborate 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 reagents and assays.
• Review design history files, validation reports, risk assessments and product specs.
• Ensure documentation aligns with quality systems and regulatory expectations.
• Support change control activities and assess impact of changes.
• Provide technical support during audits and inspections.
• Assist audit readiness activities and ensure inspection-ready documentation.
• Collaborate with Regulatory, Quality, Marketing, Manufacturing, Medical Affairs and Operations.

Skills

Immunology

Flow cytometry

Assay development

Technical documentation

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Life Science

Job description

MillenniumSoft Inc. in San Diego, CA, is seeking a Scientist II for Reagent and Assay Development. This 12-month contract role supports sustainment and improvement of reagent and assay products, integrating assays with flow cytometry tools to advance next‑gen research platforms.

The candidate will review documentation, participate in change control and audits, and collaborate across Regulatory, Quality, Marketing, Manufacturing, and Operations to meet objectives.