Scientist II: Reagent & Flow Cytometry Development

MillenniumSoft Inc; San Diego (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

MillenniumSoft Inc. is seeking a Scientist II, Reagent and Assay Development, to support sustainment and continuous improvement of reagent and assay products throughout their lifecycle, on site in San Diego, California.

You will coordinate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations to drive business objectives, prepare technical documentation, and ensure compliance with design controls and inspection readiness.

Qualifications

• Bachelor's degree in Life Science or equivalent required.
• Minimum 2 years in a research/biotech setting with relevant technologies.
• Strong understanding of immunology and cell-based assays.

Responsibilities

• Support reagent and assay sustainment projects for marketed products.
• Review and approve technical documentation for reagent and assay products.
• Review design history files, validation reports, risk assessments, and product specs.
• Ensure alignment with quality systems and regulatory expectations.
• Support change control activities and assess impacts of changes.
• Provide technical support during audits and readiness activities.
• Collaborate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations.

Skills

Immunology

Flow cytometry

Assay development

Technical documentation

Cross-functional collaboration

Communication

Education

Bachelor's degree in Life Science

Job description

MillenniumSoft Inc. is seeking a Scientist II, Reagent and Assay Development, to support sustainment and continuous improvement of reagent and assay products throughout their lifecycle, on site in San Diego, California.

You will coordinate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations to drive business objectives, prepare technical documentation, and ensure compliance with design controls and inspection readiness.