Senior Commercialization Process Engineer

Natera•San Carlos, CA

About The Position

Natera is seeking a Senior Commercialization Process Engineer to bridge assay development and scalable laboratory production. This bench-level role is embedded early in the New Product Introduction (NPI) process and works with Molecular Assay Development, Bioinformatics, Engineering, Lab Operations, and other teams to help ensure new oncology products are designed for reliable commercial-scale production from the outset. It is focused on the transition between R&D and operations rather than steady-state production. The role evaluates workflows, automation feasibility, software and informatics readiness, and operational scalability. The engineer identifies workflow gaps, bottlenecks, manual steps, and potential failure modes during development, then documents operational requirements and recommendations to support launch readiness. The position also contributes to NPI risk assessments and design transfer, and supports end-to-end testing in production environments. The position requires a relevant scientific or engineering degree, with experience requirements dependent on degree level: a bachelor’s degree plus 10 years of relevant experience, a master’s degree plus 7 years, or a Ph.D. plus 4 years. Compensation is listed as $141,636–$177,045 USD, with eligibility for additional compensation and benefits.

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, or a master’s degree plus 7 years of experience, or a 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 laboratory 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, including Excel, and basic statistical analysis.
Strong written and verbal communication skills, including the ability to draft technical reports, SOPs, and training documentation.
Ability to work cross-functionally with scientific, engineering, and operational teams.
Ability to manage multiple priorities, drive tasks to completion, and operate effectively in a fast-paced environment.

Nice To Haves

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

Responsibilities

Embed in NPI programs from feasibility through design transfer, providing a Lab Operations perspective on workflow design, automation feasibility, and scalability.
Partner with Molecular Assay Development, Pathology, Automation, Software Engineering, and other teams to assess molecular workflows such as WES, WGS, and RNA-Seq, as well as tissue workflows such as histology, H&E, and IHC, for operational readiness.
Identify cross-disciplinary design decisions that could create production risk or technical debt before launch.
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.
Conduct hands-on and modeled workflow assessments to identify bottlenecks, manual steps, and failure modes for resolution 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 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.