Senior Technical Manager

Roles & Responsibilities

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

Tell employers what skills you have

Troubleshooting

Predictive Maintenance

Quality Assurance

Technology Transfer

ISO

Product Lifecycle Management

Process Validation

Biomedical Engineering

Equipment Qualification

Audits

Technical Leadership

Accounting Research

Reagent

Audit