Senior Commercialization Process Engineer

Natera•San Carlos, CA

3d•$141,636 - $177,045

About The Position

Natera is seeking a Senior Commercialization Process Engineer to serve as a critical bridge between assay development and scalable lab production. This bench-level role is embedded early in the New Product Introduction (NPI) process and works alongside Molecular Assay Development, Bioinformatics, Engineering, and Lab Operations to ensure new oncology products are designed for production from the outset. This is not a steady-state production role. The position suits someone who can work in the ambiguous, fast-moving space between R&D and operations, identify workflow gaps, bridge informatics and lab systems, and ensure processes can run reliably and repeatably at commercial scale. The role requires a relevant scientific or engineering degree, substantial relevant experience, a strong foundation in molecular and cell biology, biotechnology, or biochemistry, and working knowledge of applicable laboratory regulations and quality requirements. The position is eligible for additional compensation and Natera’s Total Rewards program.

Requirements

B.S. or M.S. in Bioengineering, Molecular Biology, Biochemistry, Biomedical Engineering, or a closely related discipline; an equivalent combination of education and experience may be considered.
Bachelor’s degree plus 10 years of relevant experience, Master’s degree plus 7 years of experience, or Ph.D. plus 4 years of experience.
Strong scientific background in molecular and cell biology, biotechnology, or biochemistry.
Working knowledge of CAP, CLIA, NYSDOH, and applicable GxP requirements, with the ability to follow and establish SOPs.
Familiarity with WES, WGS, RNA-seq, or other scientific workflows at the bench level, including the ability to execute, troubleshoot, evaluate, and implement workflows for scalability.
Experience with NPI, product development, or assay launch processes.
Experience at the intersection of lab operations and informatics or LIMS.
Strong working knowledge of laboratory systems, automation, and software integration, with demonstrated success implementing process optimization projects.
Proficiency with data analysis tools; Excel is required, and basic statistical analysis is expected.
Strong written and verbal communication skills, including the ability to draft technical reports, SOPs, and training documentation.
Ability to work cross-functionally across scientific, engineering, and operational teams to achieve shared goals.
Flexibility, self-direction, and ability to manage multiple priorities, drive tasks to completion, and operate effectively in a fast-paced environment.

Nice To Haves

Proficiency with Python, SQL, or AI-enabled data analysis tools.

Responsibilities

Embed within NPI programs from feasibility through design transfer, bringing a bench-level Lab Operations perspective to workflow design, automation feasibility, and scalability requirements.
Partner with Molecular Assay Development, Pathology, Automation, Software Engineering, and other teams to evaluate molecular workflows (WES, WGS, RNA-Seq) and tissue-based workflows (histology, H&E, IHC) for operational readiness and identify design decisions that could create production risk or technical debt.
Serve as the Lab Operations liaison to informatics and LIMS teams, ensuring software systems, sample tracking, and data pipelines are production-ready and validated before Process Validation begins.
Perform hands-on and modeled workflow assessments to identify bottlenecks, manual steps, and failure modes to address during development.
Contribute Lab Operations input to User Needs documentation, FMEA, and process risk assessments at each NPI stage gate.
Collaborate with Engineering on instrument qualification and automation integration to ensure new platforms are operationally ready at launch.
Document workflow findings, improvement recommendations, and operational requirements in a structured format for the NPI Launch Playbook.
Support end-to-end testing in production environments, ensuring test conditions reflect launch-state systems and volumes.
Perform other duties as assigned.