Scientist III, Reagent and Assay Development

MillenniumSoft Inc; San Diego (CA); Vor Ort; USD 65.000 - 87.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Flow cytometry

Immunology

Assay development

Technical documentation

Collaboration across functions

Ausbildung

Bachelor's degree in Life Science

Jobbeschreibung

Position: Scientist III, Reagent and Assay Development

Location: San Diego, CA

Duration: 12 Months

Total Hours/week: 40.00

Shift: 1st Shift

Client: Medical Devices Company

Job Category: Research and Development

Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Rate of Pay: $55/hr

Job Description

• 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 II 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
• Provide technical support 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 2 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 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