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.