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Senior Director, Assay Development at DELFI Diagnostics, Inc. - ApplyBlast

Senior Director, Assay Development

DELFI Diagnostics, Inc.

5 months ago

Remote

Full Time

Senior

1 applicant

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About this role

Senior Director of Assay Development at DELFI Diagnostics, leading end-to-end assay development for NGS-based cancer screening platforms, ensuring compliance with regulatory standards, and driving product strategy across R&D, Quality, and Manufacturing.

Responsibilities

Own end-to-end assay development strategy across all LDT and IVD programs
Establish and enforce compliant analytical performance claims aligned to CLIA, FDA, and international IVD standards
Contribute to and/or lead Formal Design Reviews at key milestones
Oversee reagent development and qualification, automated process scale-up, and statistical process control (SPC) for lab production environments
Lead design transfer activities across programs, ensuring robust handoffs to manufacturing and sustained assay performance at commercial scale

Skills

Qualifications

PhD or MS in Molecular Biology, Biochemistry, Biomedical Engineering, Genomics, or a related discipline12+ years in IVD and/or LDT assay development in regulated environmentsHands-on expertise in AV and design verification of multi-marker genomic or 'omic-based assaysDeep knowledge of IVD regulatory frameworks: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDRProven track record designing scalable processes, SOPs, quality systems, and operational infrastructure in regulated IVD environments

About DELFI Diagnostics, Inc.

delfidiagnostics.com

Headquarters

Palo Alto, California, United States

Company Size

51-200 employees

Founded

2019

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DELFI Diagnostics is a biotech company focused on saving lives through early cancer detection with blood-based tests. Their platform analyzes cell-free DNA fragmentation patterns using genome-wide sequencing and machine learning to noninvasively detect and localize multiple cancer types from a routine blood draw. DELFI develops tests for screening, diagnosis, and disease monitoring and advances validation through clinical collaborations and trials. The company’s mission is to deliver sensitive, scalable liquid‑biopsy solutions that enable earlier intervention and better outcomes for patients.