Principal Scientist, Clinical Diagnostics - Hybrid/Relocation

Placements24; Durban; Hybrid; ZAR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Private healthcare

Life insurance

Retirement fund

Relocation support

Hybrid work options

Professional development

Job summary

Placements24 in Durban, a leader in diagnostic innovation, seeks a Principal Scientist to head Clinical Diagnostics. You will lead assay development, oversee regulatory submissions, and mentor R&D staff in a fast-paced, quality-driven environment.

The role requires a PhD and 8+ years in diagnostic assay development with expertise in PCR, ELISA, NGS, and regulatory pathways such as IVDR and FDA. You will collaborate across departments to translate research into validated products and contribute

Qualifications

• Ph.D. in Biochemistry, Molecular Biology, Immunology, or related field.
• Minimum of 8 years of diagnostic assay development experience in biotech/pharma.
• Proven track record of bringing diagnostic products through regulatory approval.
• Strong understanding of clinical trial design and statistical analysis.

Responsibilities

• Lead R&D in development of new diagnostic assays, including molecular and immunoassay platforms.
• Oversee experimental design, execution, and data analysis for validation studies.
• Ensure compliance with ISO 13485, IVDR, and other regulatory guidelines.
• Manage and mentor a team of R&D scientists and lab personnel.
• Collaborate with clinical affairs, manufacturing, and quality assurance departments.
• Contribute to IP strategy and patent filings.
• Present research findings to senior management and external stakeholders.
• Evaluate and implement new technologies to enhance diagnostics.

Skills

Molecular diagnostics

PCR

ELISA

Data analysis

Regulatory knowledge

Education

PhD in Biochemistry/Molecular Biology/Immunology

Tools

PCR

ELISA

NGS

Microarrays

Job description

Placements24 in Durban, a leader in diagnostic innovation, seeks a Principal Scientist to head Clinical Diagnostics. You will lead assay development, oversee regulatory submissions, and mentor R&D staff in a fast-paced, quality-driven environment.

The role requires a PhD and 8+ years in diagnostic assay development with expertise in PCR, ELISA, NGS, and regulatory pathways such as IVDR and FDA. You will collaborate across departments to translate research into validated products and contribute