Scientist, Reagent and Assay Development

Roles & 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

Experience Required

• 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 

Skills & Certifications

• Demonstrated ability to collaborate effectively across functions 
• Excellent written and verbal communication skills

Eligibilities & 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