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Director – Assay Development
| Company | Delfi Diagnostics |
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| Location | Palo Alto, CA, USA |
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| Salary | $210000 – $240000 |
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| Type | Full-Time |
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| Degrees | PhD |
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| Experience Level | Senior, Expert or higher |
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Requirements
- PhD in Molecular Biology, Biochemistry, Chemistry, or a similar discipline
- 8+ years of professional assay development experience, with specific experience designing and developing LDT and IVD diagnostic tests
- Proficiency in a broad range of laboratory techniques for molecular diagnostics, including immunoassays, protein biochemistry, molecular biology, proteomics, genomics, and other ‘omics
- 6+ years of experience managing technical teams to product launch in a cross-functional environment under formal design controls
- Experience developing automated processes scalable for production environments (IVD preferred)
- Strategic and tactical leadership capabilities in building high-performance, results-driven teams
- Experience working in regulated environments (CAP/CLIA and IVD)
- Excellent written and verbal communication skills, with ability to clearly convey complex concepts
- Evidence of innovation and personal accomplishment through patents, publications, and launched LDT/IVD products
- Ability to work on-site at our Palo Alto laboratory five days a week and travel to the Baltimore office periodically
Responsibilities
- Lead the strategic design and development of LDT and IVD diagnostic tests for our cancer screening platform
- Build and manage high-performance technical teams to successfully develop and launch products under formal IVD design controls
- Drive the development of automated processes that are scalable for production environments
- Oversee cross-functional collaboration between R&D, clinical, regulatory, and manufacturing teams
- Ensure compliance with regulatory requirements including CAP/CLIA and FDA IVD standards
- Contribute to innovation through development of novel assay technologies and approaches
- Present complex technical concepts to diverse stakeholders and influence strategic decisions
- Optimize assay performance through critical parameter management and statistical process control
Preferred Qualifications
- Background in next generation sequencing technologies, blood tests, and cancer biology
- Familiarity with databases, bioinformatic analysis, and general principles of machine learning algorithms
- Experience with formal product development methodologies such as DOE, Six Sigma, statistical process control, lean
- Success building product development processes and launching products in a fast-paced startup environment
