Summary
Overview
Work History
Education
Skills
Languages
References
Timeline
Generic

Zethu Sonyoka

Cape Town

Summary

Cross functional Scientist with a strong understanding of Molecular and Micro Biology methodologies, research techniques and experimental design. Strengths include data analysis, problem-solving , troubleshooting, and report writing. Proven expertise in ISO 13485, ISO 17025, cGMP compliance and QA principles. Strong leadership in operations, team management, process optimization, and regulatory compliance to ensure efficient and high-quality production.

Overview

11
11
years of professional experience

Work History

Team Lead : Upstream and Downstream Production

Cape Biologix
10.2024 - Current
  • Identified CPPs and CQAs important for protein production and purification, maintain continuous process (upstream/downstream) improvement and seamless operations.
  • Ensure product compliance and reproducibility through QA systems (CAPA/NC/DR), resulting in greater process stability and compliance.
  • Trained and mentored 2+ manufacturing personnel, improving compliance and operational efficiency.

Team Lead: Downstream production

Cape Biologix Technologies
Pinelands
03.2023 - 09.2024
  • Supervise fill and finish operations, manage inventory and participate in batch release under compliance.
  • Draft SOPs and streamlined batch records using QbD tools, enhancing documentation clarity and promote batch reproducibility.
  • Performed risk analysis and drove resolution of process-improvements using root cause investigation tools.

Technician: Downstream production

Cape Biologix Technologies
Pinelands
05.2021 - 02.2023
  • Conducted protein purification, ensuring reproducibility and consistent yield.
  • Performed formulation and filling of finished goods, ensuring regulatory compliance and meeting sales/inventory demand.
  • Conducted quality testing (ELISA, Western blot) to validate product consistency post-fill.

R&D Associate: Microbiology

Microchem Lab Services
Woodstock
04.2016 - 03.2019
  • Conduct microbial enumeration and quantification in foodstuff as per ISO 17025 compliance.
  • Reduced lead time for microbial detection via validation of real-time PCR methods.

Intern: Microbiology

Microchem Lab Services
Woodstock
01.2014 - 12.2014
  • Perform microbial enumeration and detection in foodstuff and water
  • Instrument SME and routine lab verifications

Education

Msc - Molecular Biology

Stellenbosch University
12.2024

BTech - Biomedical Technology

Cape Peninsula University of Technology

National Diploma - Biotechnology

Cape Peninsula University of Technology

Skills

    ● Biomanufacturing & Protein Purification: FPLC, HPLC

    ● Quality Control & Assurance: ISO 13485, ISO 17025 , cGMP, QMS (CAPA, Deviation Management), Risk Assessment FMEA

    ● Molecular Techniques: PCR, Real-time PCR, DNA Extraction, ELISA, Cloning, Western blot, Resin chromatography

    ● Microbial Testing: Microscopy & staining , BSL III , Microbial culturing/enumeration/detection, Cell banking

Languages

1,C2

References

  • Mr. Scott De Beer, R&D Scientist: Innovations Lead, Cape Biopharms,scott@capebiologix.com,
  • Dr Marisa Klopper, Supervisor, TB Host Genetics, Marisat@sun.ac.za, +27 82-940-2633

Timeline

Team Lead : Upstream and Downstream Production

Cape Biologix
10.2024 - Current

Team Lead: Downstream production

Cape Biologix Technologies
03.2023 - 09.2024

Technician: Downstream production

Cape Biologix Technologies
05.2021 - 02.2023

R&D Associate: Microbiology

Microchem Lab Services
04.2016 - 03.2019

Intern: Microbiology

Microchem Lab Services
01.2014 - 12.2014

Msc - Molecular Biology

Stellenbosch University

BTech - Biomedical Technology

Cape Peninsula University of Technology

National Diploma - Biotechnology

Cape Peninsula University of Technology

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