SITE HEAD

The Site Head will serve as the senior executive responsible for the overall leadership and operational excellence of our manufacturing facility. This role encompasses comprehensive oversight of manufacturing operations, engineering systems, facilities management, environmental health and safety programs, and quality control activities. The successful candidate will lead the establishment of our greenfield facility from the construction phase through commercial production, building a high-performing organization that delivers safe, compliant, and cost-effective manufacturing operations.

Application Process

Qualified candidates should submit a comprehensive application including:

• Detailed curriculum vitae highlighting relevant experience
• Cover letter outlining interest and qualifications for the role
• Professional references from previous supervisors and colleagues
• Examples of successful facility startups or major operational improvements

Employment Type:

Full-time, permanent position

Application Deadline

Applications will be reviewed on a rolling basis until the position is filled.

Key Responsibilities

Manufacturing Operations Management

• Lead teams responsible for the manufacture of monoclonal antibody production including upstream and downstream processing
• Ensure adherence to Good Manufacturing Practices (GMP) and regulatory compliance
• Oversee production planning, scheduling, and capacity utilization
• Implement lean manufacturing principles and continuous improvement initiatives
• Oversee technology transfer activities and process validation

Engineering & Technical Services

• Lead engineering teams responsible for equipment maintenance, utilities, and process optimization
• Oversee facility automation systems, process control, and data integrity
• Manage capital projects and facility expansion initiatives
• Ensure optimal performance of critical manufacturing equipment and systems
• Implement predictive maintenance programs and asset management strategies

Quality Control & Regulatory Compliance

• Ensure all products meet specified quality standards and regulatory requirements
• Oversee quality control laboratories and analytical testing programs
• Manage regulatory submissions and inspections from health authorities
• Implement quality management systems and documentation control
• Lead root cause analysis and corrective action programs
• Maintain compliance with international standards (ICH, WHO, US-FDA, EMA guidelines)

Environmental Health & Safety (EHS)

• Lead the development and implementation of comprehensive EHS management systems
• Ensure compliance with local and international environmental regulations
• Establish safety protocols for biological and chemical hazards
• Manage waste treatment and disposal programs
• Conduct regular safety audits and risk assessments
• Promoting a culture of safety and environmental stewardship

Facilities Management

• Oversee facility operations including utilities, security, and maintenance
• Manage facility services, space allocation, and infrastructure requirements
• Ensure compliance with building codes and safety regulations
• Coordinate with external contractors and service providers
• Manage facility security and access control systems

Human Resources & Organizational Development

• Build and lead a high-performing, diverse team of manufacturing professionals
• Develop organizational structure and staffing plans for site operations
• Implement training and development programs for technical and leadership skills
• Foster a culture of innovation, collaboration, and continuous improvement
• Manage employee relations and performance management systems
• Ensure compliance with local labor laws and regulations

Education & Experience

• Advanced degree (Ph.D., Master's, or equivalent) in Biotechnology, Chemical Engineering, Life Sciences, or related field
• Minimum 10 years of progressive leadership experience in biopharmaceutical manufacturing
• Minimum 5 years of senior management experience in biologics/monoclonal antibody production
• Proven track record of leading greenfield facility startups or major facility expansions
• Experience with regulatory inspections and compliance in multiple jurisdictions

Technical Expertise

• Deep understanding of biomanufacturing processes, particularly monoclonal antibody production
• Comprehensive knowledge of GMP regulations and quality systems
• Experience with process development, scale-up, and technology transfer
• Understanding of regulatory requirements across multiple markets (FDA, EMA, WHO, ICH)
• Knowledge of facility design, engineering systems, and automation technologies

Leadership & Management Skills

• Proven ability to build and lead large, multidisciplinary teams
• Strong strategic thinking and business acumen
• Excellent communication and stakeholder management skills
• Experience managing complex budgets and P&L responsibility
• Demonstrated ability to drive organizational change and transformation

Regional Experience (Preferred)

• Experience working in Africa or other emerging markets
• Understanding of local regulatory environments and business practices
• Cultural sensitivity and ability to work in diverse, multicultural environments
• Experience with international supply chain and logistics

Competencies & Personal Attributes

• Strong ethical foundation and commitment to patient safety
• Results-oriented with focus on operational excellence
• Collaborative leadership style with ability to influence across organizations
• Adaptability and resilience in dynamic, startup environments
• Commitment to sustainability and corporate social responsibility
• Excellent problem-solving and decision-making capabilities
• Fluency in English; knowledge of French or Kinyarwanda preferred