Job Description

Job Responsibilities

Lead the scale-up and technology transfer of new IVD products from R&D to manufacturing. Oversee process validation, method validation, and equipment qualification (IQ/OQ/PQ). Develop, optimize, and implement robust manufacturing processes for reagents, consumables, and assay kits. Provide technical expertise in troubleshooting production issues and implementing corrective actions. Ensure compliance with ISO 13485 and IVDR requirements. Collaborate with Quality Assurance (QA) and Regulatory Affairs (RA) to maintain GMP and regulatory audit readiness. Author and review technical documentation, including protocols, reports, and standard operating procedures (SOPs). Support internal and external audits, ensuring timely closure of CAPAs (Corrective and Preventive Actions). Work closely with R&D, Supply Chain, and Production teams to ensure smooth project handovers and efficient product lifecycle management. Lead cross-functional technical projects aimed at improving manufacturing yield, cost efficiency, and product stability. Support new product introduction (NPI) through risk assessment, pilot runs, and validation planning. Supervise and mentor technical engineers, scientists, and technicians. Provide training and development plans to strengthen technical competencies across teams. Promote a culture of safety, quality, and continuous improvement. Evaluate and adopt new technologies, automation systems, and analytical tools to enhance productivity and reduce waste. Drive initiatives for digital transformation, data-driven process monitoring, and predictive maintenance.

Job Qualifications

Bachelor's in Biotechnology, Biomedical Engineering, Quality Control, or related field. Minimum 5 years of experience in IVD or medical device manufacturing, with at least 2 years in a managerial or technical leadership role. Strong understanding of reagent formulation, device assembly, and diagnostic assay manufacturing processes. Proven experience with process validation, equipment qualification, and root cause analysis. Demonstrated knowledge of ISO 13485 and IVDR requirements. * Excellent project management, documentation, and leadership skills.