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Johannesburg: Manager: Biologicals (Fixed-Term Contract – 6 Months) posted by Isilumko Staffing

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Job Description

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.
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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.



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