USP is seeking a Vaccine Expert to provide assistance in
the development the legal and regulatory framework around vaccine lot release,
specifically in establishing a vaccine lot release system based on reliance on or
recognition of other NRAs’ Lot Release for the use of WHO Pre-Qualified vaccine,
and in conducting summary lot protocol review based on lot release activity for
non-PQ-ed vaccines. The Vaccine Expert will report directly to the Technical
Lead.
This consultancy has a period of performance from October - December 2025.
Location of Assignment: Remote and Phnom Penh, Cambodia.
Scope of Work:
· Provide technical assistance to NHQC
as Cambodia National Government Laboratory and Department of Drug and Food as
Cambodia National Regulatory Authority in vaccine lot release:
o Deliver in-country training on good practices for vaccine
lot release, including the development of a general policy for independent lot
release in line with WHO guidance and requirements/best practices for performing lot release
for vaccine, including quality testing across various vaccine platforms
o Provide technical assistance to develop and draft legal
and regulatory framework and establish vaccine lot release system (For PQ-ed
vaccines, the lot release is based on reliance on or recognition of other NRAs’
Lot Release. For non-PQ-ed vaccines, conducting summary lot protocol review is based
on lot release activity).
Deliverables:
· Training materials for Vaccine Lot Release training, including but not limited to
o Agenda
o Slides/presentation
o Knowledge check
o Training report
· Draft policy and procedure for vaccine lot release
Qualifications:
· At least a master’s degree in fields like biology, chemistry, biochemistry,
microbiology, or public health.
· Experience in vaccine research, development, clinical trials, epidemiology, or public
health is essential.
· At least ten years’ experience working in a public health area with expertise in
vaccine, biochemistry, biosimilar and relevant and progressively responsible
professional experience in the field of vaccine development programs and its
legal policy and framework.
· Strong understanding of country-level contexts with regard to vaccine-preventable
diseases and in-depth understanding on international guideline on the use of
vaccine, e.g., WHO TRS 978, Annex 2, 2013, and requirements of NRA Lot Release
as per WHO GBT.
· Working experience in biotechnology/biopharmaceutical industry strongly preferred
· Work experience in cGLP/cGMP environment
· Demonstrated success in engaging and working with multi-disciplinary teams and proven
ability in training and mentoring technical staff.
· Excellent oral and written communication skills in English; knowledge of the local
language is desired.
· Computer proficiency in Word, Excel, PowerPoint, and Internet.
Application Procedure:
Please send your CV, Cover Letter, 3 References, and
hourly rate (in USD) to GPH_Procurement@USP.org, by the closing date
of November 26, 2025. When submitting your applications, please write “Vaccine
Expert” in the email Subject Line of your email.
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on
building trust in the supply of safe, quality medicines. We are working to
strengthen the global supply chain so that the medicines people rely on for
health are available when needed and work as expected. USP’s Global Health
programs works with donors and partners in low- and middle-income countries to
advance access to quality-assured essential medical products and strengthen
supply chains to address critical global health threats such as COVID-19,
tuberculosis, HIV and AIDS, and maternal and child health conditions.
USP will build on its proven approach and previous experiences working with the Government of Cambodia and the National Health
Quality Control (NHQC) Laboratory to better safeguard the public from poor
quality medical products. The Technical Assistance to Strengthen Cambodia’s
Medicines Quality Assurance System program, funded by Global Fund, aims to support
the NHQC to expand its existing ISO 17025 scope of accreditation for the Physico-Chemical
(PC) Laboratory; prepare the PC laboratory for WHO prequalification; and
prepare the Microbiology (MB) Laboratory for ISO 17025 accreditation. In this
project, USP will not only provide assistance to NHQC on the scope expansion of
ISO 17025 accreditation but also support NHQC in establishing the policy on the
use of quality-assured vaccine in Cambodia, including vaccine lot release.
