Author and review SOPs, protocols, study reports, and transfer documents for production implementation; contribute to design control deliverables (design inputs/outputs, risk assessments per ISO 14971) in line with CLIA, CAP, 21 CFR Part 820/QMSR, and ISO 13485. The ideal candidate has a deep understanding of molecular biology, strong scientific curiosity, demonstrated experience in developing Next Generation Sequencing (NGS) technologies and proven experience developing and validating assays through the product development cycle.