Molecular Diagnostic Manager

About the role

The Molecular Diagnostic Manager will lead the daily production of molecular diagnostic reagents, ensuring compliance with GMP, ISO 13485, and internal SOPs. This role coordinates cross‑functional teams to deliver high‑quality products at scale.

Key responsibilities

• Supervise and train production staff, plan manpower, and manage batch production records.
• Maintain strict compliance with GMP, ISO 13485, SOPs, and quality standards.
• Monitor equipment performance, calibration, and preventive maintenance.
• Drive workflow optimisation, continuous process improvement, and cost reduction.
• Lead scale‑up from pilot to commercial batches, ensuring reproducibility and regulatory compliance.
• Implement electronic batch records and integrate LIMS for data management.
• Support incoming, in‑process, and final QC testing for open and closed molecular systems.
• Document all production activities in line with ISO 13485 and WHO guidelines.
• Participate in method validation, verification, technology transfer, and performance evaluation studies.
• Champion contamination control strategies, including cleanroom zoning and environmental monitoring.

Required profile

• Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Biochemistry or related field (preferred).
• Minimum 5 years of hands‑on experience in molecular diagnostic production within a GMP/ISO 13485 environment.
• At least 3 years of leadership experience supervising molecular reagent production teams.
• Proven track record scaling up molecular diagnostic reagent production.

Required skills

• Good Manufacturing Practice (GMP) implementation
• ISO 13485 compliance
• Standard Operating Procedure (SOP) development and adherence
• LIMS integration and electronic batch record systems
• Equipment calibration and preventive maintenance
• Method validation and verification
• Scale‑up and technology transfer of molecular reagents
• Contamination control and cleanroom management
• Analytical and clinical performance evaluation