Senior Scientist, R&D Design Transfer & Product Development

Role: Lead design transfer activities for NGS-based In Vitro Diagnostic (IVD) assays, overseeing process validation, test method development, and risk management to ensure regulatory compliance and product quality. Responsibilities: plan and execute process validations (IQ/OQ/PQ), perform stability studies, support test method validation, lead risk assessments including FMEAs, manage design history files, and handle change control and CAPA processes; partner with supply chain for raw material sourcing. Qualifications: PhD in Molecular or Cell Biology, Biotechnology, Biochemistry with 4+ years or Master's with 7+ years or Bachelor's with 10+ years of industry experience; hands-on expertise in NGS workflows (DNA/RNA extraction, enrichment, library prep) or DNA techniques like PCR; strong analytical, experimental, and data analysis skills; excellent cross-functional communication; knowledge of design controls, QMS, FDA, ISO 13485, and GLP/GMP environments preferred; experience with automated liquid handling and IVD product development is a plus. HighValue: molecular biology, NGS, DNA/RNA workflows, design validation, regulatory compliance, IVD/medical device development, post-IND stage. WorkSetup: hybrid or onsite; no specific travel mentioned.