Scientist III, Reagent and Assay Development

MillenniumSoft Inc; San Diego (CA); On-site; USD 63,000 - 89,000; Full time

Job summary

Medical Devices Company in San Diego, CA seeks a Scientist III for Reagent and Assay Development. This contract position focuses on sustaining and improving reagent and assay products, with emphasis on documentation, audits, and cross-functional collaboration within a dynamic team.

The role requires a Life Science degree and at least five years in related R&D, immunology, and flow cytometry, plus strong writing and communication skills to support regulatory readiness and product lifecycle

Qualifications

• 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.

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

Project leadership

Technical writing

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Science

Job description

Position : Scientist III, Reagent and Assay Development

Location : San Diego, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

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

Pay rate:$55/hr

ON site

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 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