Head Of Manufacturing

Job Description

Bio Usawa Biotechnology Ltd, a pioneering African biotechnology company, is seeking an experienced Head of Manufacturing to lead the establishment and operation of our greenfield monoclonal antibody manufacturing facility in Rwanda. This is a unique opportunity to build manufacturing capabilities from the ground up and serve the African continent's growing demand for advanced biologics. The successful candidate will oversee all manufacturing operations including upstream bioprocessing, downstream purification, fill and finish operations, and packaging activities.

Kigali, Rwanda (with potential for international travel)

Full-time, Permanent

• Manufacturing Operations Management
• Technical Excellence
• Regulatory Compliance & Quality Assurance
• Team Development & Leadership

• Oversee end-to-end manufacturing operations including upstream cell culture, downstream purification, fill and finish, and packaging
• Ensure optimal production efficiency, yield optimization, and cost-effective operations
• Implement lean manufacturing principles and continuous improvement initiatives
• Manage production planning, scheduling, and capacity utilization
• Ensure adherence to Good Manufacturing Practices (GMP) and regulatory compliance

• Drive process development, optimization, and scale-up activities
• Oversee technology transfer from development to commercial manufacturing
• Implement robust process controls and monitoring systems
• Lead troubleshooting and problem-solving for manufacturing issues
• Ensure product quality and consistency across all manufacturing operations

• Ensure compliance with international regulatory standards including US-FDA, EMA, WHO and local African regulatory authorities
• Collaborate with Quality Assurance teams to maintain GMP compliance
• Support regulatory submissions, inspections, and audits
• Implement and maintain comprehensive documentation systems

• Recruit, develop, and retain top manufacturing talent
• Foster a culture of safety, quality, and continuous improvement
• Provide technical mentorship and career development opportunities
• Build cross-functional collaboration with R&D, Quality, and Commercial teams

• Advanced degree (Master's/PhD) in Chemical Engineering, Biotechnology, Biochemistry, or related field
• Minimum 10-15 years of experience in biopharmaceutical manufacturing with at least 5 years in senior leadership roles
• Proven experience in monoclonal antibody or protein therapeutics manufacturing.
• Demonstrated experience in greenfield facility startup and commissioning

• Deep understanding of upstream bioprocessing including cell culture, bioreactor operations, and process optimization
• Extensive knowledge of downstream purification processes including chromatography, filtration, and viral clearance
• Hands-on experience with fill and finish operations including aseptic processing, vial filling, and lyophilization
• Knowledge of packaging operations and cold chain management
• Proficiency in process analytical technology (PAT) and process control systems

• Strong understanding of GMP regulations and quality systems
• Experience with regulatory submissions and agency interactions
• Knowledge of international regulatory requirements (US-FDA, EMA, WHO)
• Familiarity with African regulatory landscape preferred

• Proven track record of building and leading high-performing teams
• Strong project management and change management capabilities
• Excellent communication and stakeholder management skills
• Experience in budget management and cost optimization
• Ability to work in a fast-paced startup environment

• Experience working in emerging markets or developing economies
• Knowledge of African healthcare landscape and market dynamics
• Experience with single-use technologies and continuous manufacturing
• Six Sigma or Lean Manufacturing certification
• Multilingual capabilities a plus (English, French, Kinyarwanda)

• Entrepreneurial mindset with ability to thrive in a startup environment
• Strong commitment to advancing healthcare access in Africa
• Excellent problem-solving and decision-making abilities
• Cultural sensitivity and ability to work in diverse, multicultural teams
• Passion for innovation and continuous learning
• High ethical standards and integrity