Molecular Diagnostic Manager – Reagent Manufacturing
About Microhaem Scientifics and Medical Supplies Limited
Microhaem Scientifics and Medical Supplies Limited (MHS) is Uganda's first indigenous IVD manufacturer, established in 2012 and operating Africa's first 4th Generation IVD manufacturing plant at Plot 16 A-C Martyrs Way, Ntinda, Kampala. MHS manufactures high-grade point-of-care and molecular diagnostic kits for HIV, Malaria, Sickle Cell and other high-burden diseases in Africa. Quality is a core value, with manufacturing certified under GMP and ISO 13485, approved by NDA-Uganda, with WHO PQ and CE-Marking ongoing. Its vision is to protect and improve the quality of people's lives through innovation, manufacture and supply of high quality medical products, and its mission is to make patients' lives better by applying the latest technology to increase equitable access. For the Molecular Diagnostic Manager – Reagent Manufacturing role, this context is directly relevant: you will lead end-to-end manufacturing of molecular diagnostic reagents (PCR/qPCR, RT-PCR, DNA/RNA extraction) within a GMP/ISO 13485, WHO TGS/TSS compliant cleanroom environment, driving scale-up from pilot to commercial batches and ensuring globally competitive quality.
Job Details
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.
- Location: Plot 16 A-C Martyrs Way Ntinda, Kampala, Uganda
- Duty Station: Plot 16 A-C Martyrs Way Ntinda | Kampala, Uganda | Kampala
- Employment Type: Full-time
- Industry: Healthcare
- Work Hours: 8
- Base Salary: Not Disclosed
- Reporting Line: Director Human Resource, Microhaem Scientifics and Medical Supplies Limited, P.O Box 73496, Kampala, Uganda
- Application Method: Email application as a single PDF (CV, certified copies of academic transcripts and certificates, supporting documents, daytime telephone contacts, and addresses of two referees including current employer where applicable). Applications must reference the Job Title in the subject. Physical applications will not be accepted.
Key Duties and Responsibilities
- Lead daily production of molecular diagnostic reagents
- Ensure strict compliance with GMP, ISO 13485, SOPs, and quality systems
- Supervise and train production staff; plan manpower
- Oversee batch production records, documentation, and CAPA (Corrective and Preventive Actions)
- Monitor equipment performance, calibration, and preventive maintenance
- Drive workflow optimization and continuous process improvement
- 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 systems
- 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 quality
- Ensure SOPs and batch records are in place and consistently followed
- 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 development and transfer
- Train junior production staff on GMP/ISO 13485-compliant molecular reagent production techniques and GMP principles
Qualifications, Skills and Requirements
- 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 environment (60 months)
- Minimum of 3 years' leadership experience as a supervisor of molecular reagent production teams
- Minimum 5 years in molecular diagnostics manufacturing, with at least 4 years in GMP/ISO 13485-compliant manufacturing leadership
- Proven track record in scaling up molecular diagnostic reagent production, compliant with GMP/ISO 13485
- 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
- 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
- Level of Education: Bachelor Degree
Job Summary
- Job Category: Science & Engineering, Management, Manufacturing, Business Operations, Healthcare
- Job Type: Full-time
- Deadline of this Job: Friday, September 18 2026
- Duty Station: Plot 16 A-C Martyrs Way Ntinda | Kampala, Uganda | Kampala
- Posted: Tuesday, August 25 2026
- No of Jobs: 1