Consultants - Chemistry, Manufacturing and Controls (CMC) Expertise at World Health Organization (WHO)

World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

We are recruiting to fill the position below:

Job Title: Consultant - Chemistry, Manufacturing and Controls (CMC) Expertise for the Assessment of Vaccines for the Purpose of the WHO Prequalification and Emergency Use Listing

Job ID: 2500615
Location: Anywhere
Job type: Full-time
Contractual Arrangement: External consultant
Organization: HQ/VAX Vaccines & Immunization Devices Assessment

Background  

• The World Health Organization (WHO), through its Regulation and Prequalification Department provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies. This service is called prequalification.
• The purpose of the WHO prequalification assessment is to provide assurance that candidate vaccines: (a) meet WHO recommendations on quality, safety and efficacy, including compliance with WHO’s recommended standards for good manufacturing practices (GMP) and good clinical practice (GCP); and (b) meet the operational packaging and presentation specifications of the relevant United Nations agency. Prequalification also supports the specific needs of national immunization programmes with regards to vaccine characteristic such as potency, thermostability, presentation, labelling and shipping conditions.  
• The aim is to ensure that vaccines provided through the United Nations for use in national immunization services in different countries are safe, effective and suitable for the target populations at the recommended immunization schedules and with appropriate concomitant products.
• This important work is carried out with the support of international experts in Non-Clinical, Clinical and Chemistry, Manufacturing and Controls (CMC) evaluation of biological medicinal products, specifically vaccines. WHO is making a call to increase the number of consultants/experts available to support this very important public health responsibility.

Deliverables

• Produce timely assessment reports (AR) of the reviewed information.
• Report on critical, major, and other deficiencies detected during the review of the documentation/data (assigned to the consultant)
• Assess the applicant's responses to queries raised in the AR and decide on the adequacy of each response. Several sets of queries may be necessary.
• Provide WHO with a recommendation and final remarks on the evaluation based on the documentation assigned for review to the consultant. This should be based on the most updated scientific and regulatory grounds. 

Qualifications, experience, skills and languages
Educational Qualifications:
Essential:

• Advanced university degree in medicine, biology, pharmacy or microbiology.  

Desirable:

• A postgraduate degree in biostatistics. 

Experience
Essential:

• Over ten years’ experience in the pharmaceutical field.
• Extensive experience in the area of CMC of vaccines including the understanding of Quality Systems.
• Experience in the regulation, manufacturing and control of vaccines, and ability to work in a complex international environment.
• Experience in monitoring of regulations and regulatory systems of NRAs, including lot release, manufacture and laboratory good practices, laboratory access, post-marketing surveillance (quality aspects) and other activities like writing regulatory procedures. 

Desirable: 

• Participation in WHO evaluations of NRA and vaccine manufacturers as well as in other WHO activities.

Skills:
Essential:

• Expert must have technical skills and knowledge on the development, strengthening and monitoring of regulatory systems for vaccines, drugs, biologicals, and medical devices.  

Desirable:

• Familiarity with WHO prequalification procedure, with WHO activities in strengthening the capacity to regulate clinical trials, vaccines as a biological medical product and /or with the NRA assessment procedure.

Languages required:
Essential:  

• Expert knowledge of English.

Remuneration
Band level C: USD 500 - 625 per day.

Application Closing Date
28th February, 2025.

How to Apply
Interested and qualified candidates should:
Click here to apply online