Scientist 2, Biology

MillenniumSoft Inc; Milpitas (CA); On-site; USD 90,000 - 128,000; Full time

Job summary

Millenniumsoft in Milpitas, CA is seeking a Scientist III to advance reagent and assay development, including sustainment, troubleshooting, and documentation across lifecycle stages. You will work with cross-functional teams to ensure quality and regulatory readiness while applying immunology and flow cytometry expertise.

The role emphasizes independent project leadership, strong communication, and collaboration with Regulatory, Quality, Marketing, Manufacturing, and Operations to support

Qualifications

• Bachelor's degree in Life Science or related field.
• 5+ years in a research setting, clinical/diagnostic lab, or biotech R&D.
• Strong understanding of immunology and flow cytometry.
• Experience authoring and reviewing technical documentation.
• Ability to lead projects independently and 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 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 impact of proposed changes.
• Serve as a technical subject matter expert during audits.
• Support audit readiness activities and ensure technical documentation is inspection-ready.
• Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations teams to support business objectives.

Skills

Flow cytometry

Immunology

Assay development

Technical documentation

Project leadership

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Science

Tools

Regulatory documentation tools

Job description

Bill Rate $79.13

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions.

Our people make all the difference in our success.

Scientist III, Reagent and Assay Development

The Reagent & Assay Development Group focuses on providing differentiated reagent solutions that uncover truths in biology and medicine. Teams of hardworking scientists are responsible for initiating and driving the reagent and assay development projects and integrating assays and flow cytometry instruments to create the next generation of research and clinical Flow Cytometry platforms. Products include cell analyzers, cell sorters, reagents, assays and software. The Scientist III is responsible for supporting the sustainment and continuous improvement of reagent and assay products throughout their lifecycle.

Primary 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

Minimum 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

Desired Qualifications

Experience with flow cytometry-based diagnostic products

Experience supporting regulatory inspections and quality audits

Familiarity with design controls, risk management, verification/validation, and change control processes

Strong immunology, cancer biology and cell biology knowledge

Experience in reagent and assay development

Experience with product lifecycle management