Senior Commercialization Process Engineer
Natera · San Carlos, CA · $141.6k–$177k
Posted by Natera on their careers site · View the original posting
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Mid level · asks for 4+ years
Open 3 days
The posting, as Natera wrote it
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, troubleshoo
[…]
s include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com .
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information
- BBB announcement on job scams
- FBI Cyber Crime resource page