IVD Reagent Development Lead, Manufacturing & Validation

Delfidiagnostics; Palo Alto (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

DELFI Diagnostics, Inc. in Palo Alto seeks a senior scientist to lead IVD reagent development for cfDNA/multi-omic assays. Define specs, oversee validation, and manage tech transfer from R&D to Operations in a regulated environment.

You will collaborate with biostatisticians, bioinformaticians, and engineers to design experiments, qualify QC methods, and plan stability studies. On-site work 3–5 days per week with occasional supplier audits.

Qualifications

• PhD or Master’s with extensive experience in assay/reagent development in regulated settings.
• Experience with IVD diagnostics (NGS cfDNA/multi-omic) under 21 CFR Part 820 or ISO 13485.
• Strong communication and mentorship skills across cross-functional teams.

Responsibilities

• Own the IVD reagent development plan and define reagent specs and manufacturing processes.
• Lead the Reagent Development and Operations team; oversee process validation and design transfer.
• Define reagent criticality and develop FMEA to guide testing and change control.
• Develop QC methods for reagent lot release and integrate with batch records.
• Evaluate contract reagent manufacturers and manage supplier relationships; participate in audits.
• Plan reagent stability studies and support Verification/Validation activities.
• Collaborate with biostatisticians, bioinformaticians, engineers, and scientists on experiments.

Skills

Molecular biology

Biochemistry

Team mentorship

Cross-functional collaboration

Education

PhD with 8+ years industry assay/reagent development

Master’s with 10+ years industry assay/reagent development

Tools

GxP laboratory environments

IVD regulatory familiarity

Job description

DELFI Diagnostics, Inc. in Palo Alto seeks a senior scientist to lead IVD reagent development for cfDNA/multi-omic assays. Define specs, oversee validation, and manage tech transfer from R&D to Operations in a regulated environment.

You will collaborate with biostatisticians, bioinformaticians, and engineers to design experiments, qualify QC methods, and plan stability studies. On-site work 3–5 days per week with occasional supplier audits.