Senior Clinical Antibody Reagent Scientist

Cynet Systems • San Diego, CA

6d

About The Position

Our client, a leading provider of antibody reagents to the research and clinical immunology communities, is seeking an outstanding Senior Scientist to join their highly motivated Single-Vial Clinical Antibody Reagents team. The Senior Scientist is responsible for the development, optimization, characterization, and lifecycle management of single-vial fluorescent antibody reagents and multicolor flow cytometry solutions for clinical applications. This role leads complex product development activities, including reagent formulation, stability assessment, analytical characterization, and design transfer, while collaborating closely with Regulatory Affairs, Quality, Operations, Manufacturing, and Product Management. The successful candidate will provide technical leadership, troubleshoot complex challenges, and contribute to the commercialization of high-quality, compliant clinical reagent products.

Requirements

• Strong expertise in flow cytometry, immunology, and fluorescent antibody reagent development.
• Experience with antibody-fluorochrome conjugates, reagent formulations, panel optimization, and stability studies.
• Knowledge of FDA QSR, ISO 13485, EU IVDR, Design Controls, ISO 14971, CAPA, and risk management processes.
• Experience supporting DHF documentation, verification and validation studies, design transfer, and product commercialization.
• Proficiency with flow cytometry platforms such as FACSLyric™, FACSymphony™, ZE5™, or equivalent.
• Experience with FACS Suite™, FlowJo™, FCS Express™, FACSDiva™, and Microsoft Office.
• Strong analytical, problem-solving, project leadership, and communication skills.
• Ability to work effectively in cross-functional teams within a regulated environment.
• Ph.D. in Immunology, Cell Biology, Biomedical Sciences, or related discipline with 2+ years of industry experience; OR M.S. with 6+ years of relevant industry experience; OR B.S. with 8+ years of relevant industry experience.
• Minimum 5 years of experience in flow cytometry reagent development, clinical diagnostics, antibody-based assays, or related biotechnology products.
• Experience working in FDA, ISO 13485, IVDR, or other regulated product development environments.

Nice To Haves

• Experience with Design Controls, Design Transfer, Verification & Validation, risk management, and regulatory documentation preferred.
• Direct experience developing single-vial or ready-to-use clinical antibody reagents.
• Knowledge of clinical diagnostic applications, including immunophenotyping and immune monitoring.
• Experience transferring products from R&D into commercial manufacturing.
• Experience supporting regulatory inspections, audits, and global product registrations.

Responsibilities

• Design and execute complex flow cytometry experiments supporting new product development and product lifecycle management.
• Develop, optimize, and characterize fluorescent antibody reagents, multicolor panels, and single-vial reagent formulations.
• Analyze and interpret experimental data, prepare technical reports, and maintain accurate documentation.
• Lead troubleshooting activities, investigations, and implementation of corrective actions.
• Support product development within regulated environments, including Design Control, Verification & Validation, Risk Management, Design Transfer, and Change Control activities.
• Author and review technical documentation, including protocols, reports, DHF records, risk assessments, and product specifications.
• Collaborate with cross-functional teams to achieve project milestones and support commercialization efforts.
• Ensure compliance with quality systems, regulatory requirements, and laboratory safety standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree