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
Vacancy title:
Molecular Diagnostic Manager – Reagent Manufacturing
Jobs at:
Microhaem Scientifics and medical supplies
Deadline of this Job:
Friday, September 18 2026
Duty Station:
Plot 16 A-C Martyrs Way Ntinda | Kampala, Uganda | Kampala
Summary
Date Posted: Tuesday, August 25 2026, Base Salary: Not Disclosed
JOB DETAILS:
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.
Work Hours: 8
Experience in Months: 60
Level of Education: bachelor degree
Job application procedure
Interested in applying for this job?
Click here to submit your application now
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All eligible applicants should submit their applications with detailed and up-to-date CVs, certified copies of academic transcripts and certificates, and any other supporting documents, daytime telephone contacts, and addresses of two referees (including the current employer, where applicable) addressed to:
The Director Human Resource,
Microhaem Scientifics and Medical Supplies Limited
Plot 16 A-C Martyrs Way Ntinda
P.O Box 73496, Kampala, Uganda
Applications should be sent as a single file in Portable Document Format (PDF). Applications should reference the Job Title in the subject. Please note that physical applications will not be accepted.
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