Senior Commercialization Process Engineer
Core
Bridge assay development and scalable lab production for oncology products during New Product Introduction (NPI), ensuring workflows are designed for commercial scale from day one.
Role type
Senior Commercialization Process Engineer (NPI)
Builds
Scalable molecular and tissue-based diagnostic workflows (WES, WGS, RNA-Seq, histology, IHC) for oncology products
Domain
Biotechnology / Oncology Diagnostics
Required skills
Molecular and cell biology, NPI/product development, Lab operations and LIMS integration, Laboratory automation and software integration, Process optimization, Data analysis (Excel, Python, SQL)
Preferred skills
Statistical analysis, AI-enabled tools
Technologies
WES, WGS, RNA-Seq, LIMS, Python, SQL, Excel
Responsibilities
Embed in NPI programs to evaluate workflow design and automation feasibility; Partner with development teams to identify production risks; Serve as Lab Ops liaison for informatics and LIMS validation; Perform hands-on and modeling workflow assessments to identify bottlenecks; Contribute to User Needs, FMEA, and risk assessments; Collaborate on instrument qualification and automation integration; Document operational requirements for the NPI Launch Playbook.
Seniority
Senior, hands-on IC
