Biologicals Manager

About the role

The Biologicals Manager will lead the biologicals units, including animal facilities and the Quality Control department, to deliver high‑quality, cost‑effective antivenom products. The role ensures compliance with GLP, GMP and veterinary regulations while driving technological innovation.

Key responsibilities

• Oversee animal units and QC to produce antivenom in line with GLP, GMP and veterinary standards.
• Research, develop and transfer new test methods and technologies to improve division efficiency.
• Provide operational guidance using laboratory, manufacturing and immunological expertise.
• Approve GMP activities such as change controls, deviations, CAPA, procedures and validation protocols.
• Maintain GLP and GMP quality systems to meet product specifications and cost targets.
• Design calculation spreadsheets, author SOPs and specifications for animal and QC processes.
• Liaise with professional bodies to ensure legislative compliance.
• Manage client and supplier relationships, including venom contract suppliers, budgets and performance.
• Collaborate with external research institutes on antivenom design and global projects.

Required profile

• 4‑year degree/diploma in Pharmacy, Health Sciences, Microbiology or Immunology.
• Registration with the South African Pharmacy Council as a Pharmacist.
• Minimum 6 years post‑qualification experience in pharmaceutical manufacturing, preferably biologicals.
• At least 1 year experience in immunological process management.
• Strong knowledge of GMP, GLP, aseptic procedures and QC testing.
• Experience with validation, OSHA, finance and research statistics.
• Computer literacy in MS Office, CAD and Laboratory Information Systems.

Required skills

• GMP compliance
• GLP compliance
• Aseptic techniques
• Quality Control testing
• Method development and transfer
• Validation procedures
• OSHA safety standards
• Financial budgeting
• Research statistics
• MS Office suite
• CAD software
• Laboratory Information System (LIS)