Senior Process Engineer, Assay Development
Location: San Diego, CA
Job Type: Full-Time
Compensation: $131,000 - $140,000
Position Overview
We are seeking a Senior Process Engineer to drive the development, automation, and productionalization of clinical next-generation sequencing (NGS) assays. 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 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. 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.
Key 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.
• 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.
• Support development and maintenance of process documentation, including process maps, equipment lists, and bills of materials, in alignment with design control expectations.
• 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.
• Partner cross-functionally with chemistry, automation, software, quality, and lab operations to drive sustainable process improvements.
Qualifications
Required:
• BS/MS in Chemical Engineering, Bioengineering, Biochemistry, Biotechnology, or a related field.
• 6+ years of experience in process engineering or process development within clinical diagnostics, NGS, biotech, or other regulated laboratory environments.
• 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.
• 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.
