Senior Scientist - Reagent & Assay Development (Flow Cytometry)

Millenniumsoft; San Diego (CA); Presencial; USD 63 000 - 89 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Project leadership

Technical writing

Cross-functional collaboration

Communication skills

Formação académica

Bachelor's degree in Life Science

Descrição da oferta de emprego

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