Molecular Diagnostic Manager – Reagent Manufacturing job at Microhaem Scientifics and medical supplies

Background information about the job or company (e.g., role context, company overview)

Microhaem is seeking an experienced Molecular Diagnostic Manager 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.

Responsibilities or duties

• Lead daily production of molecular diagnostic
• Ensure strict compliance with GMP, ISO 13485, SOPs, and quality
• Supervise and train production staff; plan manpower
• Oversee batch production records, documentation, and CAPA
• Monitor equipment performance, calibration, and preventive
• Drive workflow optimization and continuous process
• Lead scale-up of production from pilot to commercial batches, ensuring reproducibility and regulatory
• Implement electronic batch records and LIMS integration for
• Support incoming, in-process, and final QC testing requirements for open systems and/or closed molecular
• Document all production activities in compliance with ISO 13485 and/or WHO TGS/TSS
• Participate in method validation, verification, and technology development and transfer
• Identify opportunities for process optimization and cost reduction without compromising reagent
• Ensure SOPs and batch records are in place and consistently
• 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
• Train junior production staff on GMP/ISO 13485-compliant molecular reagent production techniques and GMP principles.

Qualifications or requirements (e.g., education, skills)

• 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
• 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

Experience needed

• Minimum 5 years of hands-on experience in molecular diagnostic production in a GMP/ISO 13485-compliant manufacturing
• 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
• Experience with both open and closed molecular
• Hands-on expertise with automated liquid handling, lyophilisation, and cleanroom mixing
• 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
• Ability to mentor and build resilient teams.

• Lead daily production of molecular diagnostic
• Ensure strict compliance with GMP, ISO 13485, SOPs, and quality
• Supervise and train production staff; plan manpower
• Oversee batch production records, documentation, and CAPA
• Monitor equipment performance, calibration, and preventive
• Drive workflow optimization and continuous process
• Lead scale-up of production from pilot to commercial batches, ensuring reproducibility and regulatory
• Implement electronic batch records and LIMS integration for
• Support incoming, in-process, and final QC testing requirements for open systems and/or closed molecular
• Document all production activities in compliance with ISO 13485 and/or WHO TGS/TSS
• Participate in method validation, verification, and technology development and transfer
• Identify opportunities for process optimization and cost reduction without compromising reagent
• Ensure SOPs and batch records are in place and consistently
• 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
• 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
• Experience with both open and closed molecular
• Hands-on expertise with automated liquid handling, lyophilisation, and cleanroom mixing
• 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
• 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
• 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