Senior Manager, Development and Design Transfer
Core
Lead the transfer of next-generation sequencing (NGS) IVD/PMA assays from R&D to Operations, ensuring compliance with Quality Systems Regulations and Design Control.
Role type
Senior Manager, Design Transfer
Builds
Production-ready NGS assays and diagnostic tests for oncology and genetic disease management
Domain
Biotechnology / Molecular Diagnostics / Oncology
Required skills
NGS assay development, Design Transfer planning, Risk management (FMEA, Hazard Analysis), Statistical analysis (DOE, Cpk, Gage R&R), Process validation, Team leadership, Regulatory compliance (FDA, ISO 13485), SOP creation
Preferred skills
PhD in molecular biology, Experience with single-site oncology assays, Bioinformatics alignment, Supply chain establishment
Technologies
NGS platforms, Statistical software, Quality Management Systems (QMS)
Responsibilities
Plan and execute design transfer activities from late-stage development to launch; Lead test method development, characterization, and validation; Manage a multidisciplinary team of scientists; Ensure compliance with FDA, ISO, and GLP/GMP regulations; Partner with Operations, R&D, and Regulatory Affairs for seamless product launch
Seniority
Senior Manager, hands-on leadership
