Senior Staff Scientist, Clinical Assay On Market Support
Core
Senior technical leader ensuring on-market library prep and clinical assay products meet performance, quality, regulatory, and customer expectations through investigations, improvements, and lifecycle management.
Role type
Senior Staff Scientist (Clinical Assay On Market Support)
Builds
On-market library prep and clinical assay products (Oncology, NIPT, whole genome sequencing, infectious disease)
Domain
Genomics / Clinical Diagnostics / Regulated Medical Devices
Required skills
Molecular biology, assay development, next-generation sequencing, design controls, risk management, verification and validation, change management, CAPA, failure investigation, regulatory compliance, cross-functional collaboration, technical mentoring
Preferred skills
PhD in Genomics/Genetics/Molecular Biology/Biochemistry/Bioengineering, Illumina sequencing platforms, sample preparation methods, library preparation assays, enrichment workflows, IVD/RUO/clinical product support, people leadership
Technologies
Next-generation sequencing platforms, Illumina sequencing platforms, library preparation assays, enrichment workflows
Responsibilities
Lead complex technical and cross-functional activities for design changes, troubleshooting, and investigations; Set technical direction for assay development, product performance, manufacturing issues, and quality events; Evaluate technical risks and develop data-driven recommendations; Collaborate with Scientists, Engineers, Bioinformaticians, Quality, Regulatory, and Commercial teams; Lead risk analyses, FMEAs, design controls, and failure investigations; Mentor junior scientists and provide technical coaching
Seniority
Senior Staff, hands-on technical leader with mentorship responsibilities