Senior Staff Process Engineer, Assay Development

Foresite Labs (Stealth Co) • San Diego, CA

1d • Onsite

About The Position

We 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.

Requirements

• BS/MS in Chemical Engineering, Biochemistry, Biotechnology, or related field
• 10+ years of experience in process engineering or process development within biotech, or regulated laboratory environments
• Demonstrated experience supporting assays through development, validation, and deployment
• Hands-on experience with automation of laboratory workflows
• Proven ability to lead technically complex projects across multidisciplinary teams
• Ability to recruit, mentor, and grow a high-performing team

Nice To Haves

• Prior experience supporting FDA-regulated assays
• Experience with high-throughput clinical lab operations
• Background in data-driven process optimization
• Exposure to reagent manufacturing, consumables, or platform-level process integration
• History of scaling processes from pilot to production-level volumes
• Comfortable operating in an evolving, resource-constrained environment where processes are still being built

Responsibilities

• Design and develop scalable assays for manufacturing and qualification with a focus on yield, robustness and throughput
• Characterize and optimize assay workflows and processes, working with automation engineering and assay development teams
• Develop and execute equipment methods, working with internal team members
• Build and maintain process maps, equipment list, and bill of materials for various assays
• Plan and execute method and process validation activities
• Lead tech transfer of assays to lab operations, ensuring readiness for routine clinical use, performing cross-functional investigations to resolve process issues and drive sustainable improvements
• Mentor junior process engineers and scientists to establish best process engineering practices within the organization

Benefits

• 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.
• Competitive compensation and equity package, comprehensive benefits, and flexibility to support work-life integration.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior