Senior Staff Process Engineer, Assay Development

Location: San Diego, CAJob Type: Full-Time$175,000-$185,000Position OverviewWe are seeking a Senior Staff Process Engineer to lead process development, optimization, and scale-up of assays. This role sits at the intersection of assay development, automation, quality, and clinical operations, and combines technical leadership with hands-on work in a dynamic, high-growth environment.In this role, the Senior Staff Process Engineer will lead a small team as a hands-on technical lead and is responsible for developing and optimizing assay workflows and equipment. The candidate must be highly effective communicator and coordinator, requiring close partnership with internal teams.Key ResponsibilitiesDesign and develop scalable assays for manufacturing and qualification with a focus on yield, robustness and throughputCharacterize and optimize assay workflows and processes, working with automation engineering and assay development teamsDevelop and execute equipment methods, working with internal team membersBuild and maintain process maps, equipment list, and bill of materials for various assaysPlan and execute method and process validation activitiesLead tech transfer of assays to lab operations, ensuring readiness for routine clinical use, performing cross-functional investigations to resolve process issues and drive sustainable improvementsMentor junior process engineers and scientists to establish best process engineering practices within the organizationQualificationsRequired:BS/MS in Chemical Engineering, Biochemistry, Biotechnology, or related field10+ years of experience in process engineering or process development within biotech, or regulated laboratory environmentsDemonstrated experience supporting assays through development, validation, and deploymentHands-on experience with automation of laboratory workflowsProven ability to lead technically complex projects across multidisciplinary teamsAbility to recruit, mentor, and grow a high-performing teamPreferred:Prior experience supporting FDA-regulated assaysExperience with high-throughput clinical lab operationsBackground in data-driven process optimizationExposure to reagent manufacturing, consumables, or platform-level process integrationHistory of scaling processes from pilot to production-level volumesComfortable operating in an evolving, resource-constrained environment where processes are still being builtWhy Join UsInfluence 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. Competitive compensation and equity package, comprehensive benefits, and flexibility to support work-life integration. We are an equal opportunity employer. We thrive on diversity and collaboration.Compensation Range: $175K - $185K