Senior Process Engineer, Assay Development

Senior Staff Process Engineer, Assay Development

Location:

San Diego, CA

Job Type: Full-Time

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. 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, our leadership team brings a proven track record of translating scientific insight into successful commercial products.

Our investors include some of the most respected names in healthcare and deep tech.

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 a highly effective communicator and coordinator, requiring close partnership with internal teams.

• 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

• Required:
• 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

• Preferred:
• 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

• 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.

Compensation Range: $175K - $185K