Assistant Manager, Vaccines and Biologicals, KBI 4 at The Kenya Biovax Institute

Job Description

Job Purpose:
The Assistant Manager, Vaccines and Biological – Fill and Finish shall be responsible for fill finish
processes of vaccines and biologics products in preparation for distribution, compliance with
regulatory standards, ensuring smooth inventory management 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; while also supervising a team to achieve
operational goals within the department
Requirements:
i. A minimum period of ten (10) years of relevant work experience and three (3) years of which
must have been in a Supervisory position in the Public or Private Sector;
ii. Master’s degree in the following disciplines of science: pharmacy, microbiology,
biomedical engineering, biology, medical laboratory sciences, biotechnology, and
Chemistry (analytical, industrial, organic, biochemistry, materials science) or equivalent
qualification from a recognized institution;
iii. Bachelor’s degree in the following disciplines of science: pharmacy, microbiology,
biomedical engineering, biology, medical laboratory sciences, biotechnology, and Chemistry (analytical, industrial, organic, biochemistry, materials science) or equivalent
qualification from a recognized institution;
iv. Management course lasting not less than four (4) weeks from a recognized institution;
v. Membership to a professional body;
vi. Training in GMP and GLP or experience;
vii. Training in Quality Management Systems;
viii. Proficiency in computer applications;
ix. Shown merit and ability as reflected in work performance and results.

Job Specification
Key Competencies and skills
i. Analytical and conceptual skills;
ii. Coaching and mentorship skills;
iii. Communication skills;
iv. Negotiation and Conflict management skills;
v. Adaptability; and
vi. Results-driven.

Key Duties & Responsibilities
i. Coordinating the formulation and fill-and-finish operations, ensuring all processes are
optimized for efficiency and compliance;
ii. Ensuring compliance to GMP, aseptic processing, and cleanroom management standards
across all production stages;
iii. Leading the preparation of biological bulk drug substance (BDS) in closed controlled systems to prevent contamination as prescribed by ICH Q7, ICHQ9, ISO 14644, ISO 14001,
WHO GMP and Waste Management Guidelines;
iv. Co-ordinating in-process quality control (QC) measures during production in liaison with
relevant functional areas;
v. Organizing and supervising daily tasks for formulation team and conducting regular
meetings;
vi. Monitoring and evaluating the production environment in the aseptic fill-and-finish
manufacturing areas in liaison with relevant functional areas;
vii. Leading the formulation of vaccines and biological products, ensuring compliance with
GMP and aseptic processing standards;
viii. Spearheading the development and implementation of contamination control strategies,
including cleanroom and aseptic process management;
ix. Spearheading process optimization initiatives to improve efficiency, reduce waste, and
enhance product quality;
x. Mentoring and coaching Senior Production Scientists, fostering a culture of continuous
improvement;
xi. Monitoring and evaluating monthly, quarterly, and yearly production schedules and
recommending areas of improvement;
xii. Monitoring and evaluating risk management measures and plans in the Department;
xiii. Developing and implementing Strategies, Policies, guidelines and SOPs for Vaccines and
Biologicals;
xiv. Managing the integration of new products into the production line, including technology
transfer from R&D.
xv. Developing and reviewing procurement plans, budgets, and workplans, for Vaccines and
Biologicals production;

Terms of Service
The successful applicant will be appointed for five (5) year contract term and may be eligible for
reappointment as per the Kenya BioVax Human Resource Policy and Procedures Manual.
Applications should include the following:
• 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