Senior Technical Manager

ABIORES PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading IVD manufacturing company in Singapore is seeking a seasoned professional to lead technology transfer and scale-up of new IVD products. The ideal candidate will have at least 5 years of experience in medical device manufacturing, including leadership roles. Responsibilities include overseeing process validation, ensuring compliance with regulatory standards, and mentoring technical teams. Exceptional project management and technical skills are essential for this role.

Qualifications

• Minimum 5 years of experience in IVD or medical device manufacturing.
• At least 2 years in a managerial or technical leadership role.
• Strong understanding of reagent formulation and diagnostic assay manufacturing.

Responsibilities

• Lead the scale-up and technology transfer of new IVD products.
• Oversee process validation and equipment qualification.
• Develop and implement robust manufacturing processes.
• Ensure compliance with ISO 13485 and IVDR requirements.

Skills

Leadership

Project management

Technical expertise

Process validation

Knowledge of ISO 13485

Education

Bachelor’s in Biotechnology, Biomedical Engineering, Quality Control, or related field

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.