Molecular Diagnostic Specialist – Reagent Manufacturing

About the Company: Microhaem Scientifics & Medical Supplies Limited is a Ugandan-based company established in 2012, specializing in the manufacture and supply of high-quality, affordable IVD testing kits, equipment, and medical supplies, serving Uganda and the Eastern Africa region. The company is committed to ensuring a constant supply of reliable healthcare products to improve patient care. With a strong focus on customer service and product quality, MHS aims to expand its reach globally. Microhaem Scientifics & Medical Supplies Limited invites applications from qualified individuals to fill the following vacant positions.

Reports to:                              Production Manager, with matrix accountability to Quality Control Manager

Type of Contract:                   Fixed Term

Department:                            Production (Molecular Reagents Manufacturing)

Duty Station:                           Microhaem Scientifics, Uganda  

Supervisory Authority Over: Molecular Scientists  

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:

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

QUALIFICATIONS & EXPERIENCE

1. Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Biochemistry, or related field preferred.
2. Minimum 5 years of hands-on experience in molecular diagnostic production in a GMP/ISO 13485-compliant manufacturing plant.
3. Minimum of 3 years’ leadership experience as a supervisor of molecular reagent production teams.
4. Proven track record in scaling up molecular diagnostic reagent production, compliant with GMP/ISO 13485.
5. Minimum 5 years in molecular diagnostics manufacturing, with at least 4 years in GMP/ISO 13485-compliant manufacturing leadership

KEY COMPETENCIES

1. Strong command of molecular reagent production, i.e., PCR/qPCR, RT-PCR, DNA/RNA extraction, and reagent formulation.
2. Experience with both open and closed molecular systems. Hands-on expertise with automated liquid handling, lyophilisation, and cleanroom mixing systems.
3. Knowledge of GMP, ISO 13485, IMDRF, GHTF, CLSI, and WHO TGS/TSS frameworks for IVD regulation and guidance.
4. Strategic leadership in manufacturing scale-up. Strong regulatory and compliance mindset.
5. Ability to mentor and build resilient teams.
6.  

All eligible candidates should submit their applications with detailed and up to date CVs, certified copies of academic transcripts and certificates and any other supporting documents, day time telephone contacts and addresses of two referees (including the current employer (where applicable) to:

                    The Director Human Resources,

                    Microhaem Scientifics and Medical Supplies Limited
                    Plot 16 A-C Martyrs Way Ntinda
                    P.O Box 73496, Kampala, Uganda    

Applications should be hand delivered to the HMS reception at the Kampala OR sent by email to: recruitment@microhaem.co.ug as a single file in Portable Document Format (PDF).

                     Deadline: Friday, 12^th December 2025, by 5:00 pm

Please note that only shortlisted applicants will be contacted.