Manager: Biologicals (Fixed-Term Contract – 6 Months)

SUMMARY:
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POSITION INFO:

Our client is seeking a highly skilled Manager: Biologicals to oversee the activities of the Biologicals Unit, including the management of animal units and the Quality Control (QC) department. The successful candidate will ensure the production of high-quality and cost-effective anti-venom in compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Veterinary requirements.

Key Responsibilities:

• Oversee and manage the Biologicals Unit, ensuring efficient operations in line with industry standards.
• Supervise animal units and the QC department to maintain high-quality anti-venom production.
• Investigate, implement, and develop biological industry technologies to enhance efficiency.
• Conduct research, develop new test methods, and facilitate method transfers within SAVP.
• Provide operational guidance and utilize laboratory, manufacturing, and immunological expertise.
• Oversee and approve GMP documentation, including change controls, deviations, CAPs, procedures, and validation protocols.
• Ensure compliance with GLP, GMP, and cost-effective operational systems within SAVP.
• Develop calculation spreadsheets for test methods and processes, ensuring data integrity.
• Author and maintain Standard Operating Procedures (SOPs) and specifications for stables, small animals, and quality control.
• Stay updated with current legislation by liaising with professional bodies.
• Manage client and supplier relationships to meet organizational and customer needs.
• Oversee venom contract suppliers, ensuring budget, contractual deliverables, performance, and quality compliance.
• Collaborate with external research institutes on technical designs, antivenom efficacy, and global research projects.

Minimum Requirements & Key Competencies:

• Degree/Diploma in Pharmacy (B.Pharm) or BSc in Health Sciences (Healthcare Technology, Microbiology, or Immunology).
• Registered with the Health Professions Council of South Africa (HPCSA) or South African Pharmacy Council (SAPC) as a Pharmacist.
• 6 years of post-qualification experience in a pharmaceutical manufacturing environment (preferably in biologicals).
• 1 year of experience in immunological process management.
• Strong knowledge of GMP, GLP, aseptic procedures, and Quality Control testing.
• Understanding of validation processes and Occupational Health and Safety Act (OHSA) compliance.
• Knowledge of general finance and research statistics (at least 1 year).
• Proficient in MS Office, CAD & LIS.
• Strong communication (verbal & written), analytical, problem-solving, and general management skills.