HEAD OF MANUFACTURING

Bio Usawa; Oregon (WI); On-site; USD 180,000 - 240,000; Full time

Job summary

Bio Usawa Biotechnology Ltd. seeks an experienced Head of Manufacturing to lead the construction and operation of a greenfield monoclonal antibody facility in Kigali, Rwanda.

The role oversees upstream bioprocessing, downstream purification, fill/finish, and packaging, building world-class manufacturing capabilities for the African continent. The candidate will drive process development, technology transfer, and continuous improvement while ensuring GMP compliance, quality systems, and

Qualifications

• Advanced degree in Chemical Engineering, Biotechnology, or related field.
• 10–15 years in biopharmaceutical manufacturing with at least 5 in senior leadership.
• Proven monoclonal antibody or protein therapeutics experience.
• Experience in greenfield facility startup and commissioning.

Responsibilities

• Oversee end-to-end manufacturing including upstream/downstream, fill/finish, and packaging.
• Drive cost optimization, yield improvement, and lean manufacturing.
• Ensure GMP compliance and regulatory submissions.
• Lead cross-functional teams with R&D, Quality, and Commercial.

Skills

Leadership

Project management

Stakeholder management

Communication

Team development

Education

Master's/PhD in Chemical Engineering or Biotechnology

Tools

Process analytical technology (PAT)

GMP knowledge

Job description

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.

Location

Kigali, Rwanda (with potential for international travel)

Employment Type

Full-time, Permanent

Job Responsibilities

Key Responsibilities

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

Manufacturing Operations Management

• 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

Technical Excellence

• 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

Regulatory Compliance & Quality Assurance

• 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

Team Development & Leadership

• 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

Qualifications

Education & Experience

• 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

Technical Expertise

• 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

Regulatory & Quality Experience

• 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

Leadership & Business Skills

• 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

Preferred Qualifications

• 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)

Personal Attributes

• 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