Molecular Diagnostic Manager

JOB PURPOSE:

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.

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 tracebility.
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 optimization 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. Bachelors or Masters 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
2. Experience with both open and closed molecular
3. Hands-on expertise with automated liquid handling lyophilisation and cleanroom mixing
4. Knowledge of GMP ISO 13485 IMDRF GHTF CLSI and WHO TGS/TSS frameworks for IVD regulation and guidance.
5. Strategic leadership in manufacturing scale-up.
6. Strong regulatory and compliance mindset.
7. Ability to mentor and build resilient teams.

Remuneration:

Net pay of United States Dollar: 42000 USD 54000 USD p.a.

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 by email to: as a single file in Portable Document Format (PDF). Applications should reference the Job Title in the subject of the email. Please note that physical applications will not be accepted.

Deadline: Friday18th September 2026 by 5:00 pm.

PLEASE NOTE THAT ONLY SHORTLISTED APPLICANTS WILL BE CONTACTED.