Manager, Production (Vaccines and Biologicals) at The Kenya BioVax Institute

Job Purpose:

The Manager, Production, Vaccines and Biological Division spearheads development of formulations, filling into appropriate containers, and finishing by inspection, labelling, and packaging while keeping the product free of contamination. The Manager shall also provide overall leadership, accountability and responsibility for production activities in the division including raw materials specifications to ensure consistent availability of the department’s full range of finished products at the right quantity, quality, cost and timely manner.

Requirements:

• A minimum period of twelve (12) years relevant work experience four (4) years of which must have been in a management position in the public or private sector;
• Manufacturing and research science experience;
• Master’s degree in any of the following disciplines: Pharmaceutical Sciences, Microbiology, Biochemistry, Chemistry, Bio/chemical engineering or equivalent Life Sciences discipline from a recognized institution;
• Bachelor’s degree in the following disciplines of life sciences: pharmacy, pharmacology, microbiology, biomedical science, biomedical engineering, biology, biometry, medicine, virology, immunology, biotechnology and veterinary medicine, Chemical Engineering or Chemistry with emphasis in relevant area (analytical, industrial, organic, physical, biochemistry, materials science);
• Leadership course lasting not less than four (4) weeks from a recognized institution;
• Membership to a relevant professional body;
• Must have demonstrated merit and ability as reflected in work performance and results; and
• Meet the requirements of Chapter Six (6) of the Constitution.

Job Specification

Key Competencies and skills

• Budgeting and planning;
• Knowledge of relevant legislation and regulations;
• Analytical and conceptual skills;
• Ability to form and maintain partnerships and collaborations;
• Excellent writing and communication skills;
• High emotional intelligence;
• Organizational skills including planning, monitoring and controlling;
• Managerial skills;
• Leadership skills;
• Interpersonal skills;
• Ability to work under pressure;
• Negotiation and influencing skills;
• Team building,
• Adaptability;
• Accountability;
• Decision making and problem-solving;
• Conflict management;
• Supervisory, coaching and mentoring skills;
• Integrity; and
• Results-driven.

Key Duties & Responsibilities

• Manage the production of various vaccines and biologicals such as allergens, antigens, hormones, cytokines, enzymes, human whole blood and plasma derivatives, immune sera, immunoglobulins (including monoclonal antibodies), products of fermentation (including products derived from rDNA), and diagnostic agents for in vitro use, gene therapy, cell therapy, among others; and
• Lead in provision of safe custody of bulk drug substance (BDS) in the facility until its scheduled filling date;
• Manage the cleanroom facilities and aseptic processes that are designed to minimize contamination risk from personnel, materials, and equipment;
• Put in place measures to eliminate opportunities for contamination, from both micro-organisms or particulates;
• Guide environmental monitoring to detect anomalies or adverse trends in the aseptic fill-and-finish manufacturing techniques;
• Oversee strict maintenance of aseptic processing by controlling the contamination in the space (both viable and non-viable);
• Protect the product by controlling the bioburden and utilizing cleaning to continually control particulates (both viable and non-viable);
• Manage and maintain Good Manufacturing Practices (GMP) by utilizing a focused risk-based approach to protect the critical areas and adhere to procedures and follow good aseptic practices;
• Guide relevant parties with comprehensive and accurate information about the quality and quantities of the Institute’s products;
• Direct continuous monitoring of production processes (such as fermentation) to form part of the batch record;
• Approve manual and digital SOPs, Batch Records, and logbook documentation with detail and accuracy in a timely manner;
• Coordinate proper maintenance of the plant and equipment in liaison with relevant functional areas;
• Review all reports for accuracy, relevance and presentation to the General Manager Production in good time;
• Organize daily tasks for formulation team and conducting regular meetings;
• Lead and /or participate diligently in various committees as shall be appointed or tasked from time to time;
• Liaise with relevant functional areas to undertake training needs assessment of production personnel and provide on-job training; and
• Supervise and developing staff to create a cohesive and highly skilled team through effective mentoring, coaching, performance management, and communication. Implement the Division’s performance appraisal systems and contracts;
• Implement department’s strategies, decisions and policies as communicated by the General Manager Production;
• Coordinate divisional expenditure; and
• Provide leadership in forecasting and development of the division’s budget and work plan.