SITE HEAD
Indexed description
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
Application Deadline
Applications will be reviewed on a rolling basis until the position is filled.
Job Responsibilities
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
- 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
- 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)
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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