Manufacturing Lead (New Business Div.)

Manufacturing & Production Oversight: • Lead the design, setup, and optimization of manufacturing workflows for LDTs. • Oversee the production of molecular diagnostic assays, ensuring reproducibility and high-throughput capability. • Develop and implement standard operating procedures (SOPs) for manufacturing. • Ensure scalability of production while maintaining efficiency and costeffectiveness. • Collaborate with R&D, Quality, and Regulatory teams to transition assays from development to full-scale production. Quality & Compliance: • Ensure adherence to Good Manufacturing Practices (GMP), CLIA, CAP, and FDA guidelines for LDTs. • Implement quality control (QC) and quality assurance (QA) measures for consistency and accuracy. • Maintain comprehensive documentation and records in accordance with regulatory requirements. • Conduct risk assessments and troubleshoot manufacturing challenges. • Drive continuous process improvement (CPI) initiatives to enhance product quality and efficiency. Team Leadership & Cross-Functional Collaboration: • Build and manage a manufacturing team, providing training and development opportunities. • Work closely with R&D, Regulatory, and Clinical teams to align production with product development goals. • Collaborate with supply chain and procurement teams to ensure timely availability of raw materials and reagents. • Support validation studies, process optimization, and technology transfer activities. Technology & Innovation: • Stay updated on emerging trends in molecular diagnostics manufacturing and incorporate best practices. • Evaluate and implement automation and process optimization strategies to increase throughput. • Drive cost-reduction strategies while maintaining product quality and regulatory compliance. QUALIFICATIONS & REQUIREMENTS: • Education: Bachelor’s, Master’s, or PhD in Molecular Biology, Biotechnology, Bioengineering, Biomedical Sciences, or a related field. • Experience: • 5+ years in manufacturing management within a biotech, molecular diagnostics, or life sciences company. • Experience in scaling up LDT manufacturing and transitioning from R&D to commercial production. • Strong understanding of molecular biology techniques (e.g., PCR, NGS, qPCR, ddPCR, etc.). • Familiarity with ISO 13485, CLIA, CAP, and FDA regulatory frameworks. • Knowledge of automation, high-throughput workflows, and process validation. • Skills: • Strong leadership, problem-solving, and communication skills. • Ability to work in a fast-paced, startup environment with agility and adaptability. • Experience with lean manufacturing, Six Sigma, and continuous improvement methodologies.