Senior Scientist, Reagent & Flow Cytometry R&D

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

Job summary

Millenniumsoft, Milpitas, CA, is seeking a Scientist III in Reagent and Assay Development. The contract role focuses on sustaining and improving reagent and assay products across their lifecycle.

The position requires a Life Science bachelor’s degree and 5+ years in a related setting, with strong immunology and flow cytometry knowledge, plus experience authoring technical documents and leading cross-functional projects. On-site work and 40h/wk.

Qualifications

• Bachelor's degree in Life Science or related field.
• 5+ years of related experience in a research setting, clinical/diagnostic laboratory, or biotech R&D environment.
• Experience authoring and reviewing technical documentation.
• Demonstrated 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 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

Immunology

Flow cytometry

Assay development

Documentation & compliance

Project leadership

Education

Bachelor's degree in Life Science

Tools

Flow cytometry instruments

Job description

Millenniumsoft, Milpitas, CA, is seeking a Scientist III in Reagent and Assay Development. The contract role focuses on sustaining and improving reagent and assay products across their lifecycle.

The position requires a Life Science bachelor’s degree and 5+ years in a related setting, with strong immunology and flow cytometry knowledge, plus experience authoring technical documents and leading cross-functional projects. On-site work and 40h/wk.