Vaccines Development & Manufacturing Expert

1. Bachelor of Medicine and Surgery (MBChB)
   
2. Master’s degree, PhD or equivalent advanced qualification in Vaccinology, Biotechnology, Virology, Immunology, Microbiology, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Bioprocess Engineering or a related
   
3. Demonstrated industry experience in vaccine development, production or
   
4. Strong understanding of GMP-regulated vaccine or biologics
   

Required Expertise

1. Strong vaccine R&D and Product Development
   
2. Vaccine Manufacturing & Production
   
3. Upstream & Downstream Bioprocessing
   
4. Process Development, Optimization & Scale-Up
   
5. Technology Transfer
   
6. Formulation, Filling & Aseptic Processing
   
7. GMP & Quality Systems
   
8. Process Validation & Qualification
   
9. Manufacturing Readiness & Facility Operations
   
10. Vaccine & Biologics Regulatory Requirements
    

Vaccine Research, Development and Product Innovation

• Lead and support vaccine research and development activities from concept through product
  
• Design, evaluate and optimize vaccine formulations, production processes and manufacturing
  
• Identify and assess emerging vaccine technologies, platform innovations and manufacturing approaches for adoption.
  
• Contribute to product development strategies, feasibility studies and technology
  

Process Development and Manufacturing Scale-Up

• Develop and optimize upstream and downstream bioprocesses for vaccine
  
• Lead process scale-up activities from laboratory and pilot-scale operations to commercial
  
• Establish robust, reproducible and cost-effective manufacturing
  
• Monitor process performance and implement continuous improvement initiatives to enhance productivity and
  

Technology Transfer and Manufacturing Readiness

• Lead the transfer of vaccine technologies from R&D into manufacturing
  
• Prepare and execute technology transfer protocols and
  
• Support facility readiness, equipment qualification and operational preparedness for vaccine
  
• Collaborate with internal and external partners to ensure successful implementation of transferred
  

Oversight of Vaccine Manufacturing Operations

• Provide technical oversight and guidance for vaccine production
  
• Support production planning, execution and troubleshooting of manufacturing
  
• Ensure adherence to approved manufacturing procedures, specifications and production
  
• Monitor critical process parameters and recommend corrective actions where
  

Quality Assurance, Validation and Regulatory Compliance

• Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and applicable regulatory
  
• Develop and review validation protocols, reports and qualification
  
• Support process validation, cleaning validation, equipment qualification and method validation
  
• Participate in internal and external audits, inspections and regulatory
  

Analytical Testing and Quality Control Support

• Support development and implementation of analytical methods for vaccine
  
• Interpret analytical test results and provide scientific
  
• Work closely with Quality Control and Quality Assurance teams to investigate deviations and quality
  
• Ensure product safety, potency, purity and consistency through scientifically sound quality systems.
  

Risk Management and Continuous Improvement

• Identify technical and operational risks affecting vaccine development and
  
• Lead root cause investigations and implement corrective and preventive actions (CAPA).
  
• Promote process optimization, cost reduction and operational excellence
  
• Drive continuous improvement programs to enhance manufacturing efficiency and product
  

Regulatory and Technical Documentation

• Prepare, review and maintain technical reports, manufacturing records, protocols, SOPs and regulatory
  
• Contribute to the preparation of dossiers for regulatory approvals and product
  
• Ensure integrity, accuracy and traceability of manufacturing and development
  

Cross-Functional Collaboration

• Work closely with Research & Development, Production, Quality Assurance, Quality Control, Regulatory Affairs and Engineering
  
• Provide technical guidance during project planning and
  
• Liaise with external consultants, academic institutions, technology providers and regulatory authorities as
  

Capacity Building and Technical Leadership

• Mentor, train and develop technical staff involved in vaccine development and
  
• Build institutional capacity in vaccine production technologies and GMP-compliant
  
• Provide expert technical advice to management on vaccine manufacturing strategy, investments and capability
  
• Support the establishment of sustainable vaccine manufacturing capacity in Uganda and across
  

Upstream Processing

• Strain/Cell Line Selection & Engineering: Expertise in choosing, modifying, and banking viral strains, bacterial cells, or mammalian/yeast expression
  
• Bioreactor Operation: Managing microbial or cell culture growth parameters (pH, temperature, dissolved oxygen, and nutrient feed) to maximize
  
• Inactivation & Attenuation: Applying chemical or physical methods to safely weaken or kill pathogens without destroying their immunogenic
  

Downstream Processing

• Purification & Isolation: Utilizing chromatography, ultrafiltration, and tangential flow filtration (TFF) to separate the target antigen from cellular impurities.
  
• Formulation & Stabilization: Combining antigens with adjuvants, buffers, and stabilizers to ensure product efficacy and extended shelf-life under cold-chain
  
• Aseptic Filling & Packaging: Operating specialized barrier-isolator filling lines and packaging units under sterile conditions to prevent
  

Quality Assurance & Control (QA/QC)

• Analytical Characterization: Performing potency assays, quantitative PCR (qPCR), and immunogenicity tests to verify product safety and batch
  
• Current Good Manufacturing Practices (cGMP): Strict adherence to regulatory standards governing facility design, documentation, and cleanroom
  
• Data Integrity & Computerized Validation: Managing electronic quality management systems (eQMS) and ensuring manufacturing data
  

Process Development & Regulatory Compliance

• Technology Transfer: Scaling up bench-scale processes to commercial industrial suites while maintaining reproducibility.
  
• Quality-by-Design (QbD): Implementing risk management frameworks to design processes that consistently meet predefined product quality.
  
• Regulatory Navigation: Preparing documentation for clinical trial approvals, lot release criteria, and compliance audits by stringent health