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Assay Development information

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$20

$38

$60

How much do assay development jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for assay development in California is $38.16, according to ZipRecruiter salary data. Most workers in this role earn between $27.98 and $45.53 per hour, depending on experience, location, and employer.

What are some common challenges faced when developing new assays, and how can they be addressed?

Assay Development professionals often encounter challenges such as optimizing assay sensitivity and specificity, troubleshooting inconsistent results, and adapting protocols for high-throughput environments. These issues are typically addressed through systematic optimization of reagents and conditions, rigorous validation, and collaboration with cross-functional teams like R&D, quality assurance, and automation specialists. Clear documentation and regular team meetings also help in quickly identifying and resolving technical hurdles, ensuring the assay meets project goals and regulatory standards.

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

To thrive in Assay Development, you need a solid background in biochemistry, molecular biology, or a related field, often supported by a relevant degree or advanced training. Familiarity with laboratory instrumentation, data analysis software, and validation protocols is typically required, along with experience in techniques like ELISA, PCR, or cell-based assays. Strong attention to detail, problem-solving abilities, and effective collaboration are crucial soft skills in this role. These competencies ensure the accuracy, reliability, and efficiency of assays, which are critical for research, diagnostics, and product development.

What is assay development?

Assay development refers to the process of designing, optimizing, and validating analytical tests (assays) used to detect or measure specific substances, such as proteins, nucleic acids, or small molecules, within a sample. This work is crucial in fields like biotechnology, pharmaceuticals, and diagnostics, as it ensures that assays are accurate, reliable, and suitable for their intended applications. Professionals in assay development work on tailoring assay conditions, selecting appropriate detection methods, and establishing protocols to support research or clinical decision-making.

What does an assay development scientist do?

An assay development scientist designs, optimizes, and validates laboratory tests to measure specific biological or chemical substances. They work with techniques such as ELISA, PCR, or spectrophotometry, often using specialized equipment and following regulatory standards to ensure assay accuracy and reliability.

What is an assay worker?

An assay worker is a laboratory professional responsible for performing assays, which are tests used to analyze biological or chemical samples. They prepare samples, operate specialized equipment, and record data to support research, development, or quality control in fields like pharmaceuticals or diagnostics.

What is considered assay development?

Assay development is the process of designing and optimizing laboratory tests to measure specific biological or chemical substances accurately and reliably. It involves selecting appropriate detection methods, validating the assay's sensitivity and specificity, and ensuring reproducibility for research or diagnostic purposes. Assay development often requires knowledge of biochemistry, instrumentation, and regulatory standards.

What is the highest paid type of scientist?

In general, specialized scientists such as petroleum engineers, data scientists, and pharmaceutical scientists tend to have the highest salaries. Within assay development, senior roles with advanced skills in molecular techniques and regulatory knowledge can also command higher pay, especially in biotech and pharmaceutical industries.

What is the difference between Assay Development vs Laboratory Scientist?

AspectAssay DevelopmentLaboratory Scientist
CredentialsBachelor's or Master's in Life Sciences, relevant certificationsBachelor's or Master's in Life Sciences, relevant certifications
Work EnvironmentResearch labs, biotech companies, pharmaceutical firmsResearch labs, hospitals, biotech companies
Industry UsageDesigning and optimizing assays for research and diagnosticsPerforming experiments, data collection, and analysis

Assay Development focuses on creating and optimizing diagnostic or research assays, while Laboratory Scientists perform experiments and analyze data within the lab. Both roles require similar educational backgrounds and often work in similar environments, but their core responsibilities differ in scope and focus.

What are the most commonly searched types of Assay Development jobs in California? The most popular types of Assay Development jobs in California are:
What are popular job titles related to Assay Development jobs in California? For Assay Development jobs in California, the most frequently searched job titles are:
What job categories do people searching Assay Development jobs in California look for? The top searched job categories for Assay Development jobs in California are:
What cities in California are hiring for Assay Development jobs? Cities in California with the most Assay Development job openings:
Assay Development jobs near you
Senior Director, Assay Development

Senior Director, Assay Development

DELFI Diagnostics, Inc.

Palo Alto, CA

Full-time

Medical, Dental, Vision, Retirement

Posted 29 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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