Vaccines Development & Manufacturing Expert

QUALIFICATIONS & EXPERIENCE

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
    

DUTIES AND RESPONSIBILITIES:

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