USP will be leading a project to establish vaccine manufacturing capabilities at a Kenyan
pharmaceutical manufacturing company (the client) and is seeking a consultant to lead a task of
Capacity Building. The overall objective of the project is to establish a flexible human vaccine
manufacturing facility to produce three pediatric vaccines (Penta, PCV, and Rota) as well as the
capacity to produce additional pandemic-related vaccines such as the COVID-19 and endemicrelated
vaccines such against Malaria. This consultancy has a level of effort of 35 workdays,
spread between September 2021 and September 2022.
Purpose & Nature of Assignment
The consultant shall assess the technical needs of the client necessary to support the vaccine
production, and the capacity required for regulatory authorities to oversee the project and finally
develop a Capacity Building Plan. Capacity Building requires subject matter expertise in technical
functions in the manufacture of pharmaceuticals including vaccines. A consultant with this
background will represent USP on this project while being supported by technical staff within the
Kenyan office and Rockville-Headquarters. There will be local trips within Nairobi and environs
with potential for international travel.
The consultant will complete the following tasks
1. Assess the technical needs of the manufacturer necessary to support the fill-and-finish and
end-to-end production, and the capacity required for the Government of Kenya (GoK)
regulators
2. Develop a vaccine manufacturing Capacity Building Plan describing exactly when, how, for
whom, and to what end identified capacity gaps will be addressed
3. Develop notional Capacity Building Plan (CBP) to increase GoK regulatory capacity based
on relevant analysis in this and other tasks, and that go beyond the scope of the capacity
building program to be executed in this technical assistance assignment
4. Propose a monitoring and evaluation (M&E) plan to support implementation and tracking
of the recommendations.
5. Support other tasks in the project by providing information and subject matter expertise
Required Education and Experience
1. Bachelor’s degree in the areas of pharmacy, pharmaceutical manufacturing, chemistry, or
related fields. Post-qualification training in pharmaceutical quality management, research
and development, project management or any relevant field will be an added advantage.
2. Minimum 10 years’ hands-on experience in pharmaceutical production, Quality
Management Systems, technical operations and GMP compliance in finished
pharmaceutical product manufacturing facilities.
3. Good understanding of the WHO standards pharmaceutical manufacturing environments.
4. Experience in technical cooperation arrangements/ consultancies.
Preferred Experience
1. Experience in vaccine production/ regulation
2. Demonstratable experience is previous similar assignment(s)
Knowledge, Skills, and Abilities
1. Possess managerial and good communication skills
2. Project management skills
3. Excellent analytical and report writing skills
4. Good personality skills
5. Results-driven with demonstrated successful outcomes
6. Must be proficient in the use of Microsoft office suite (word processing, email, spreadsheet,
database, and Internet)
7. Effective team player, and experience with short term project implementation at national
and local levels
Deliverables
The consultant shall prepare and deliver to USP, on behalf of the client, a report containing all findings and a detailed account of all work performed under the Capacity Building Task, to include the Capacity Building Plan (CBP) and the M&E plan to support local vaccine production.
Application Procedure
If you are interested in this consulting work, please provide us with the following:
1. A cover letter demonstrating how you meet the criteria described above, and how you propose to organize the work outlined above, in a simple Gantt Chart
2. A copy of your Curriculum Vitae (CV), showing previous similar and relevant work done
3. Clarification on whether you are bidding as an individual or as a company
4. Your total hourly consultancy fees in USD, which should be inclusive of all applicable taxes.
5. If bidding as a team, indicate the lead consultant, include CVs of all team members, their hourly consultancy fees in USD (inclusive of all applicable taxes), and the estimated number of days they will work on specified tasks. Indicate the cumulative hourly consultancy rate, inclusive of all applicable taxes.
6. Your availability to do the work during the specified period
7. Names and contact details for three referees
Closing Date: The closing date for applications is September 3, 2021. Applications should be submitted to Masoud Azam, Senior Procurement Specialist, at GPH_Procurement@USP.org. When submitting your application, write, “Local Pharmaceutical Manufacturing Support Consultancy (Capacity Building) – Kenya” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets
standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary
supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are
enforceable in the United States by the Food and Drug Administration, and these standards are
used in more than 140 countries. USP’s focus on global public health extends to lower and middleincome
countries with work in over 20 countries through donor-funded programs. Our programs
are focused on building the capacity of regulatory authorities and manufacturers in ensuring
patient access to quality-assured essential medicines by providing: 1) technical assistance to
manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS,
tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health
(MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their
oversight function in ensuring the supply of quality-assured medical products.
