Foresite Labs (Stealth Co)

Foresite Labs (Stealth Co)

Senior Process Engineer, Assay Development

San Diego · Senior · Full-time

Sponsorship not specified$131k-$140kDetected 5 days ago
Clinical Laboratory TechniquesFDA RegulatoryBioinformaticsNGSMedical DevicesLeadership

About the role

  • Our investors include some of the most respected names in healthcare and deep tech.
  • This is a hands-on individual contributor role focused on translating bench-developed chemistry into robust, automated, audit-ready workflows that are ready for clinical lab deployment.
  • The role requires a builder's mindset, comfort with ambiguity, and the discipline to apply rigorous engineering practices in an early-stage environment where the process roadmap is still being defined.

Responsibilities

  • Develop, optimize, and qualify automated workflows for NGS library preparation..
  • Partner with assay development scientists to transfer bench-developed chemistry onto automation platforms, identifying and resolving robustness, scaling, and operability issues.
  • Support development and maintenance of process documentation, including process maps, equipment lists, and bills of materials, in alignment with design control expectations.
  • Partner cross-functionally with chemistry, automation, software, quality, and lab operations to drive sustainable process improvements.
  • We are a venture-backed, stealth-stage biotechnology company based in San Diego, focused on developing novel technologies that will redefine how disease is detected, characterized, and managed with a novel approach to clinical genomics.
  • We are seeking a Senior Process Engineer to drive the development, automation, and productionalization of clinical next-generation sequencing (NGS) assays.
  • The Senior Process Engineer will work in close partnership with assay development scientists, automation engineers, quality/regulatory specialists, and laboratory operations to design and qualify automated methods for library preparation, nucleic acid extraction, and sample quantitation and normalization.
  • Working knowledge of design controls and regulated development frameworks (ISO 13485, IVD or LDT context), with experience operating in a quality-driven environment.

Requirements

  • 6+ years of experience in process engineering or process development within clinical diagnostics, NGS, biotech, or other regulated laboratory environments.
  • Prior experience supporting LDT and/or FDA-regulated IVD assay development.
  • Ability to operate independently across multiple workstreams in an early-stage environment where requirements evolve.
  • Comfort operating in a stealth-stage, resource-constrained environment where processes are being built from the ground up.
  • Required:
  • BS/MS in Chemical Engineering, Bioengineering, Biochemistry, Biotechnology, or a related field.
  • Hands-on experience developing and optimizing automated laboratory workflows, including direct protocol development on liquid handling platforms.
  • Demonstrated experience supporting clinical or near-clinical NGS assays, including library preparation, nucleic acid extraction, methylation conversion, or sample QC workflows.
  • Prior experience supporting LDT and/or FDA-regulated IVD assay development. Working knowledge of design controls and regulated development frameworks (ISO 13485, IVD or LDT context), with experience operating in a quality-driven environment.
  • Practical fluency in data-driven process development methods - DOE, statistical process control, Gage R&R, root cause analysis.
  • Why Join Us
  • Influence the foundational technologies and strategies of a company poised to shape the future of clinical genomics and healthcare.
  • Work in a dynamic, collaborative environment where innovation and scientific rigor are deeply valued.
  • Join a seasoned and multidisciplinary team tackling high-impact problems at the intersection of science and engineering.

Compensation

  • $131,000 - $140,000

Company info

  • Apply DOE, SPC, and other statistical tools to characterize process performance, define operating windows, and establish in-process and release specifications.
  • Contribute to reagent and consumable manufacturing and qualification activities, including QC method development and lot release strategy.
  • Execute equipment qualification activities (IQ/OQ/PQ) for automation and ancillary instrumentation in partnership with engineering and lab operations.
  • Participate in tech transfer of NGS assays to the clinical laboratory, supporting validation activities and resolving process issues that surface during scale-up and deployment.
  • Our mission is to fundamentally transform healthcare through a convergence of innovation across multiple scientific disciplines.
  • Founded by industry veterans with decades of experience in life sciences tools and diagnostics, our leadership team brings a proven track record of translating scientific insight into successful commercial products.
  • Position Overview

Equal opportunity

  • equal opportunity employer.
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