Senior Scientist, Reagent & Assay Development

MillenniumSoft Inc

San Diego (CA)

On-site

USD 65,000 - 87,000

Full time

7 days ago

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Job summary

MillenniumSoft Inc in San Diego, CA is seeking a Scientist III in Reagent and Assay Development on a 12-month contract. This role focuses on sustaining and advancing reagent and assay products, coordinating with cross-functional teams to align with regulatory and quality expectations.

You will support design history files, validation reports, and change controls, contribute to audits, and help scale bench discoveries into robust diagnostics using flow cytometry and immunology expertise.

Qualifications

Bachelor's degree in Life Science or related field.
2+ years of related experience in a research or biotech setting.
Strong understanding of immunology, flow cytometry, and assay development.

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 quality system requirements and regulatory expectations.
Support change control activities and assess impact of proposed changes.
Provide technical support during audits and ensure inspection readiness.
Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations to support business objectives.