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How much do senior assay development scientist jobs pay per year?

As of Jun 14, 2026, the average yearly pay for senior assay development scientist in the United States is $110,545.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,500.00 and $125,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Senior Assay Development Scientist position, and why are they important?

A Senior Assay Development Scientist should possess advanced expertise in assay design, validation, and troubleshooting, supported by a degree in biochemistry, molecular biology, or a related field. Familiarity with laboratory automation platforms, high-throughput screening technologies, and software for data analysis such as Prism or SoftMax Pro is typically required. Strong project management, problem-solving, and cross-functional communication skills enhance effectiveness in leading projects and collaborating across departments. These skills are crucial for delivering robust, innovative assays that meet regulatory standards and support critical research or product development goals.

What are the typical challenges faced by a Senior Assay Development Scientist and how do they overcome them?

Senior Assay Development Scientists often encounter challenges such as optimizing assay sensitivity and specificity, troubleshooting inconsistent results, and meeting tight project timelines. To overcome these, they rely on deep scientific knowledge, rigorous method validation, and effective collaboration with other scientists, engineers, and quality assurance teams. Staying up to date on the latest technologies and regulatory requirements also helps address technical and compliance-related hurdles. By fostering open communication and drawing on multidisciplinary expertise within their teams, these professionals develop innovative solutions and ensure high-quality outcomes.

What does a Senior Assay Development Scientist do?

A Senior Assay Development Scientist designs, optimizes, and validates biochemical or cell-based assays for research, diagnostics, or drug development. They lead assay development projects, troubleshoot technical challenges, and collaborate with cross-functional teams. Their role often includes analyzing experimental data, ensuring assay reproducibility, and maintaining compliance with regulatory standards. Additionally, they mentor junior scientists and contribute to scientific publications or regulatory submissions.

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What cities are hiring for Senior Assay Development Scientist jobs? Cities with the most Senior Assay Development Scientist job openings:
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Senior Assay Development Scientist jobs near you
Infographic showing various Senior Assay Development Scientist job openings in the United States as of June 2026, with employment types broken down into 5% As Needed, 5% Full Time, 80% Part Time, and 10% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $110,545 per year, or $53.1 per hour.
Senior Director, Assay Development

Senior Director, Assay Development

DELFI Diagnostics, Inc.

Palo Alto, CA • On-site

Full-time

Medical, Dental, Vision, Retirement

Posted 2 days ago

Job description

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics' platform relies on fragmentomics - the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics' first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
  • Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.
  • Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class
  • Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.

About the role
As Senior Director of Assay Development, you will own all development activities across DELFI's NGS-based cancer screening portfolio - driving the transition of innovative assays into verified, validated, and manufacturable IVD products. Reporting to the CTO, you will lead a team of scientists and functional leaders and serve as a key voice on product strategy across R&D, Quality, Regulatory, and Manufacturing.
This role demands hands-on scientific judgment to know when and where to take calculated risks - and when not to - leading with science while anchoring every decision in pragmatism to keep programs moving against ambitious timelines without compromising quality or integrity.
This role requires 4 days in the Palo Alto office.
What you'll do
  • Own end-to-end assay development strategy across all LDT and IVD programs - from study design and execution through protocol approval, analytical validation, regulatory documentation, and FDA PMA submissions
  • Establish and enforce compliant analytical performance claims aligned to CLIA, FDA, and international IVD standards (21 CFR Part 820, ISO 13485, ISO 14971, IVDR)
  • Contribute to and/or lead Formal Design Reviews at key milestones; partner with Systems Engineering to ensure product requirements are fully addressed through design verification
  • 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
  • Report directly to the CTO; lead a team of scientists and functional leaders across assay development, validation, and manufacturing readiness
  • Design and own the operational infrastructure for the function - scalable processes, SOPs, design control frameworks, and traceability systems aligned to 21 CFR Part 820 and ISO 13485
  • Apply hands-on scientific judgment to make deliberate risk decisions - knowing where to push for speed and where standards are non-negotiable - keeping programs moving against ambitious timelines without compromising quality or integrity
  • Represent Assay Development at the executive level; align with the CTO, VP of Regulatory & Quality, and other senior leaders on portfolio priorities and product strategy

What you'll bring
Required
  • PhD or MS in Molecular Biology, Biochemistry, Biomedical Engineering, Genomics, or a related discipline
  • 12+ years in IVD and/or LDT assay development in regulated environments
  • Hands-on expertise in AV and design verification of multi-marker genomic or 'omic-based assays, with direct experience contributing to FDA regulatory submissions
  • Deep knowledge of IVD regulatory frameworks: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR
  • Proven track record designing scalable processes, SOPs, quality systems, and operational infrastructure in regulated IVD environments
  • Demonstrated ownership of late-stage development programs through design transfer and manufacturing scale-up
  • Ability to lead with science while anchoring in pragmatism - applying hands-on expertise to make sound risk judgments that keep programs on ambitious timelines without sacrificing rigor or compliance
  • 8+ years' management experience including best practices in recruiting, coaching, performance management, and career development
  • Superb communication skills including mastery in written & oral presentations, large- and small-group forums
  • Start-up mindset: passionate, innovative, accountable, able to rapidly prioritize and triage, biased to action
  • Proactive, decisive, and composed with a balance of high IQ & EQ

Preferred
  • Direct leadership of FDA PMA submissions
  • Background in reagent development, critical reagent qualification, and SPC in manufacturing environments
  • Experience in high-growth or scaling biotech/diagnostics companies; track record of multiple launched LDT/IVD products

$275,000 - $310,000 a year
Actual base pay will consider experience, skillset, education, and geography.
This role may be eligible for other forms of compensation, including an annual bonus and a new hire equity grant, subject to the terms of the applicable plans and Company discretion. All employees are also eligible for DELFI's comprehensive and competitive benefits package, including but not limited to: a flexible time-off policy; a 401(k) retirement plan; an extremely competitive medical, dental, and vision coverage; onsite lunch 3 days a week; and other wellness related offerings.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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