Molecular Diagnostic Manager - Reagent Manufacturing

Job Tittle:

Molecular Diagnostic Manager - Reagent Manufacturing

Company: Microhaem Scientifics

Reports to: Chief Manufacturing Officer, with matrix accountability to QMS Director

Type of Contract: Fixed Term

Department: Production (Molecular Reagents Manufacturing)

Supervisory Authority Over: Molecular Scientists

Duty Station: Kampala, Uganda

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:

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 & EXPERIENCE

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

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.

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: Monday, 28th September 2026, by 23:59pm (East African Time).

NOTE: This is a GLOBAL RECRUITMENT, All Potential candidates from all over the World are encouraged to Apply