Senior Process Engineer, Oncology
Core
Leading exploration of new technologies and developing validated chemistry/process changes to scale commercial molecular diagnostic assays for prenatal and cancer diagnostics.
Role type
Senior Process Engineer (High-Throughput Clinical Lab)
Builds
FDA/GMP/ISO compliant scale-up, V&V, and tech transfer procedures for molecular diagnostic assays
Domain
Molecular Diagnostics / Oncology / Prenatal Care
Required skills
Molecular biology techniques, Statistical analysis, Experimental design, GMP/ISO compliance, Root cause analysis, Six Sigma/Design-for-quality, Data science, Technical report authoring
Preferred skills
Cell-free DNA experience, Medical genetics, Automation, CLIA/CAP regulatory knowledge, Lean/JIT/TPS frameworks (via careerplan.io/jobs/4738692005-senior-process-engineer-oncology-at-billiontoone)
Technologies
R, Python, Statistical Process Control systems
Responsibilities
Source and evaluate external technologies to improve operational metrics; Develop strategies to support 2-3X annual growth in commercial volume; Build upon statistical Process Control systems to reduce failure rates; Mentor junior engineers and establish industry best practices; Facilitate technology transfer between R&D and clinical laboratory; Work with Bioinformatics to translate assay CQAs into process monitoring tools; Apply Six Sigma and 5S frameworks to improve assay capability and scalability; Lead root cause analyses to solve process issues.
Seniority
Senior, hands-on IC with mentorship responsibilities