Durban: Diagnostic Product Production Analyst posted by Pronel Consultants

Diagnostic Product Production Analyst

The successful candidate will be responsible for applying their academic background, training, and hands-on experience to perform immunoassays, recombinant protein expression, and purification processes. These activities support the production and quality control of saleable monoclonal antibodies, recombinant antigens, and MAT kits and components.

Minimum Requirements:

• Essential: BSc in Biochemistry or Microbiology
• Preferred: BSc (Hons) in Biochemistry or Microbiology

Experience:

• 23 years experience in ELISA
• 23 years experience in recombinant protein expression and purification

Specific SHE Requirements:

• Pre-employment, routine, and exit medical examinations are mandatory due to the nature of the role
• Compulsory participation in SHE-related training
• Strict adherence to SHE Instructions and Site Rules
• Use of hazardous and biologically active substances requires the correct use of PPE
• Compliance with the Occupational Health and Safety Act

Key Performance Areas:

1. QC Testing MAT ELISA Reagents and Kits

• Perform QC testing of final MAT kits
• Complete and upload results and documentation in SAP
• Conduct test and method validations in line with internal Diagnostic Product Production (DPP) protocols

2. Production & QC Recombinant Antigens & Monoclonal Antibodies

• Express and purify recombinant proteins in support of saleable monoclonal antibody production
• Assist with monoclonal antibody purification for hybridoma and validation projects, as needed
• Validate activity, specificity, and coating concentration of recombinant antigens through QC testing

3. QC Analysis Monoclonal Antibodies

• Analyze purified monoclonal antibodies using SDS-PAGE and densitometry via gel imaging software
• Document gel results and antibody purity data for submission to the Section Head: Antibody Production for final release

4. Hybridoma Laboratory Support

• Provide support with cell culture and injection procedures
• Culture monoclonal antibodies for research and commercial purposes
• Interpret and report findings to the Section Head: Antibody Production

5. Laboratory Resourcing & Equipment Maintenance

• Ensure proper maintenance of lab equipment and cleanliness
• Monitor and manage stock levels of chemicals and operational consumables
• Ensure compliance with ISO 13485 standards
• Maintain general laboratory housekeeping

Core Competencies:

• Technical/Professional knowledge in immunoassays and ELISA design/troubleshooting
• Working knowledge of ISO 13485 quality system
• Computer literacy (MS Office, SAP, LIMS)
• Attention to detail and strong analytical skills
• Effective written and verbal communication
• Personal leadership and ability to influence others
• Strong planning and organizational ability
• Collaboration and teamwork
• Relationship management and business impact awareness

If you meet the requirements please send CVS to *****@*****.co.za