Senior Commercialization Process Engineer

Natera is seeking a Senior Commercialization Process Engineer to serve as the critical bridge between assay development and scalable lab production. This bench-level role is embedded early in the NPI process, working alongside Molecular Assay Development, Bioinformatics, Engineering, and Lab Operations teams to ensure that new oncology products are designed for production from day one, not retrofitted for scale after launch.

This is not a steady-state production role. This person thrives in the ambiguous, fast-moving space between R&D and operations, identifying workflow gaps, bridging informatics and lab systems, and ensuring that what gets built can be run at commercial scale reliably and repeatably.

PRIMARY RESPONSIBILITIES

• Embed within New Product Introduction (NPI) programs from feasibility through design transfer, providing bench-level lab operations perspective on 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, identifying design decisions across multiple disciplines that could create production risk or technical debt prior to launch.
• Serve as the Lab Ops 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 modeling workflow assessments, identifying bottlenecks, manual steps, and failure modes that should be resolved during development rather than post-launch
• Contribute Lab Operations perspective 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 that feeds directly into the NPI Launch Playbook
• Support E2E testing in production environments, ensuring test conditions reflect real launch-state systems and volumes
• Perform other duties as assigned

QUALIFICTAION

• B.S. or M.S. in Bioengineering, Molecular Biology, Biochemistry, Biomedical Engineering, or a closely related discipline (equivalent combination of education and experience considered)
• Bachelor’s degree plus 10 years of relevant experience OR a Master’s degree with 7 years of experience OR PhD with 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

KNOWLEDGE, SKILLS and ABILITIES

• Familiarity with WES, WGS, or RNA-seq and other scientific workflows at a bench level, able to execute, troubleshoot, evaluate, and implement for scalability
• Experienced with NPI, product development, or assay launch processes
• Experience working at the intersection of lab operations and informatics or LIMS
• Strong working knowledge of laboratory systems, automation, software integration, with demonstrated success implementing process optimization projects
• Proficiency with data analysis tools (Excel required; Python, SQL, or AI enabled tools a plus) with basic statistical analysis 
• Strong written and verbal communication skills with ability to draft technical reports, SOPs, and training documentation
• Strong team player with a proven ability to work cross-functionally across scientific, engineering, and operational teams to achieve shared goals
• A flexible, self-starter with the ability to manage multiple priorities drive tasks to completion and operates effectively in fast-paced environments