JOB PURPOSE:

Microhaem is seeking an experienced Molecular Diagnostic Specialist to lead the end-to-end manufacturing of molecular diagnostic reagents. The ideal candidate will combine deep technical expertise, proven leadership in scale-up, and mastery of GMP/ISO 13485 frameworks to ensure high-quality, globally competitive products.

DUTIES AND RESPONSIBILITIES:

• Lead daily production of molecular diagnostic reagents.
• Ensure strict compliance with GMP, ISO 13485, SOPs, and quality standards.
• Supervise and train production staff; plan manpower allocation.
• Oversee batch production records, documentation, and CAPA activities.
• Monitor equipment performance, calibration, and preventive maintenance.
• Drive workflow optimization and continuous process improvements.
• Lead scale-up of production from pilot to commercial batches, ensuring reproducibility and regulatory compliance.
• Implement electronic batch records and LIMS integration for traceability.
• Support incoming, in-process, and final QC testing requirements for open systems and/or closed molecular platforms.
• Document all production activities in compliance with ISO 13485 and/or WHO TGS/TSS standards.
• Participate in method validation, verification, and technology development and transfer projects.
• Identify opportunities for process optimisation and cost reduction without compromising reagent quality.
• Ensure SOPs and batch records are in place and consistently updated.
• Oversee design and execution of performance evaluation studies (analytical and clinical).
• Champion contamination control strategies (cleanroom zoning, environmental monitoring).
• Work closely with R&D, QA, QC, and regulatory teams to support new product introduction.
• Train junior production staff on GMP/ISO 13485-compliant molecular reagent production techniques and GMP principles.

QUALIFICATIONS & EXPERIENCE

• 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 in a GMP/ISO 13485-compliant manufacturing plant.
• Minimum of 3 years’ leadership experience as a supervisor of molecular reagent production teams.
• Proven track record in scaling up molecular diagnostic reagent production, compliant with GMP/ISO 13485.
• Minimum 5 years in molecular diagnostics manufacturing, with at least 4 years in GMP/ISO 13485-compliant manufacturing leadership

KEY COMPETENCIES

• Strong command of molecular reagent production, i.e., PCR/qPCR, RT-PCR, DNA/RNA extraction, and reagent formulation.
• Experience with both open and closed molecular systems. Hands-on expertise with automated liquid handling, lyophilisation, and cleanroom mixing systems.
• Knowledge of GMP, ISO 13485, IMDRF, GHTF, CLSI, and WHO TGS/TSS frameworks for IVD regulation and guidance.
• Strategic leadership in manufacturing scale-up. Strong regulatory and compliance mindset.
• Ability to mentor and build resilient teams.

• Lead daily production of molecular diagnostic reagents.
• Ensure strict compliance with GMP, ISO 13485, SOPs, and quality standards.
• Supervise and train production staff; plan manpower allocation.
• Oversee batch production records, documentation, and CAPA activities.
• Monitor equipment performance, calibration, and preventive maintenance.
• Drive workflow optimization and continuous process improvements.
• Lead scale-up of production from pilot to commercial batches, ensuring reproducibility and regulatory compliance.
• Implement electronic batch records and LIMS integration for traceability.
• Support incoming, in-process, and final QC testing requirements for open systems and/or closed molecular platforms.
• Document all production activities in compliance with ISO 13485 and/or WHO TGS/TSS standards.
• Participate in method validation, verification, and technology development and transfer projects.
• Identify opportunities for process optimisation and cost reduction without compromising reagent quality.
• Ensure SOPs and batch records are in place and consistently updated.
• Oversee design and execution of performance evaluation studies (analytical and clinical).
• Champion contamination control strategies (cleanroom zoning, environmental monitoring).
• Work closely with R&D, QA, QC, and regulatory teams to support new product introduction.
• Train junior production staff on GMP/ISO 13485-compliant molecular reagent production techniques and GMP principles.

• Strong command of molecular reagent production, i.e., PCR/qPCR, RT-PCR, DNA/RNA extraction, and reagent formulation.
• Experience with both open and closed molecular systems. Hands-on expertise with automated liquid handling, lyophilisation, and cleanroom mixing systems.
• Knowledge of GMP, ISO 13485, IMDRF, GHTF, CLSI, and WHO TGS/TSS frameworks for IVD regulation and guidance.
• Strategic leadership in manufacturing scale-up. Strong regulatory and compliance mindset.
• Ability to mentor and build resilient teams.

• 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 in a GMP/ISO 13485-compliant manufacturing plant.
• Minimum of 3 years’ leadership experience as a supervisor of molecular reagent production teams.
• Proven track record in scaling up molecular diagnostic reagent production, compliant with GMP/ISO 13485.
• Minimum 5 years in molecular diagnostics manufacturing, with at least 4 years in GMP/ISO 13485-compliant manufacturing leadership