General Manager, Production at The Kenya BioVax Institute

Job Description

• The General Manager, Production shall be responsible for the overall development, performance and maintenance of the organization’s manufacturing activities to meet market demands, in compliance with the national and international regulations to obtain maximum efficiency, quality and service for the organization.

• The General Manager shall ensure technical management, supervision and control of all production processes and is also responsible for the operationalization of human vaccine production facilities that meet current Good Manufacturing Practices (cGMP) and World Health Organization Prequalification and complies with all relevant regulatory requirements.

Job Specification

Requirements:

• A minimum period of fifteen (15) years’ relevant work experience, five (5) years of which must have been in a Management position in the Public or Private Sector;
• Master’s degree in any of the following disciplines: Pharmaceutical Sciences, Microbiology, Biochemistry, Bio/chemical engineering or equivalent Life Sciences discipline from a recognized institution;
• Bachelor’s degree in the following disciplines: pharmacy, microbiology, biomedical engineering, biology, medical laboratory sciences, biotechnology, and Chemistry (analytical, industrial, organic, biochemistry, materials science) or equivalent qualification from a recognized institution;
• Leadership course lasting not less than four (4) weeks from a recognized institution;
• Membership to a professional body where applicable;
• Proficiency in computer applications;
• Demonstrated merit and ability as reflected in work performance and results;
• Fulfill the requirements of Chapter six (6) of the constitution; and
• Demonstrated merit and ability as reflected in work performance and results.

Key Competencies and Skills

• Knowledge on Commercial Production of vaccines and biologics, Manufacturing processes, research science and regulatory compliance;
• Managerial, Supervisory, coaching and mentoring skills;
• Environmental and Social Safeguards, Health and Safety Management;
• Organizational and administrative skills;
• Analytical and conceptual skills;
• Ability to form and maintain partnerships and collaborations;
• Negotiation and conflict management skills;
• Integrity; and
• Results-driven.

Key Duties & Responsibilities

• Overseeing, the development, review, and implementation of Strategies, Policies, and guidelines for Production;
• Fostering continuous improvement of production processes, focusing on reducing waste, enhancing efficiency, and improving product quality;
• Ensuring compliance with local and international regulatory requirements and standards for production;
• Overseeing the successful transfer of new technologies and products from R&D to full-scale production, overseeing scale-up processes and validation.
• Overseeing the availability and release of appropriate vaccines, pharmaceuticals, and technologies in collaboration with warehouse and quality control teams;
• Promoting innovations of new products, and scale-up or improvement of existing products and processes in collaboration with the Research and Development Department;
• Overseeing the development, and implementation of the risk management plan;
• Overseeing integration of new products and technologies into the production process;
• Ensuring production data and records are compiled and maintained as per WHO Good Manufacturing Practices (GMP) guidelines;
• Approving and managing of budgets, procurement plans, workplans;
• Ensuring timely resolution of customer complaints;
• Approving the technical specifications for production, and engineering equipment, machinery and resource;
• Developing and overseeing the implementation of advanced contamination control strategies, including cleanroom management, aseptic processing, and environmental monitoring.
• Overseeing Installation, Operation and Performance Qualification (IQ, OQ & PQ), commission and de-commission of Machines and equipment in compliance with WHO GMP guidelines;
• Contributing to current innovation, technical and operational knowledge on matters affecting pharmaceutical industry through publications, editorials, among others.
• Ensuring compliance with Occupational Safety and Health Act 2007 (OSHA) and Environmental management requirements;
• Fostering continuous process improvement and provide technical advice on engineering projects, and emerging technologies;
• Networking and collaborating with relevant stakeholders including pharmaceutical industries, regulators, MOH, and professional bodies;
• Implementing Board’s strategies, decisions and policies as communicated by the CEO;
• Providing regular, thorough and prompt communication to the CEO on key technical, financial and administrative matters; and
• Overseeing the development and implementation of staff development programs, performance appraisal systems, mentorship and coaching.

The application should include:

• Letter of Application (Indicate Vacancy Number)
• Current Resume or Curriculum Vitae with telephone number and e-mail address
• Three letters of professional reference with contact telephone numbers and e-mail addresses
• Copies of Academic Certificates and Transcripts