Molecular Diagnostic Manager - Reagent Manufacturing

About the role

Microhaem Scientifics is seeking an experienced Molecular Diagnostic Manager to lead the end‑to‑end manufacturing of molecular diagnostic reagents in Kampala, Uganda. The role combines deep technical expertise with proven leadership in scale‑up and strict adherence to GMP and ISO 13485 standards.

Key responsibilities

• Lead daily production of molecular diagnostic reagents while ensuring compliance with GMP, ISO 13485, SOPs and quality standards.
• Supervise and train production staff, plan manpower, and oversee batch records, documentation and CAPA activities.
• Monitor equipment performance, calibration and preventive maintenance; drive workflow optimisation and continuous process improvement.
• Scale‑up production from pilot to commercial batches, ensuring reproducibility and regulatory compliance.
• Implement electronic batch records and integrate LIMS for traceability.
• Support in‑process and final QC testing, method validation, verification and technology transfer.
• Champion contamination‑control strategies, including cleanroom zoning and environmental monitoring.
• Collaborate closely with R&D, QA, QC and regulatory teams on new product introductions.

Required profile

• Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Biochemistry or related field (preferred).
• Minimum 5 years hands‑on experience in molecular diagnostic production within a GMP/ISO 13485‑compliant environment.
• At least 3 years of supervisory experience leading molecular reagent production teams.
• Proven track record of scaling up molecular diagnostic reagent manufacturing.

Required skills

• Good Manufacturing Practice (GMP)
• ISO 13485 compliance
• LIMS integration
• Electronic batch record systems
• Method validation and verification
• Contamination control techniques
• Cleanroom zoning and environmental monitoring