Consultant –Local production and assistance in product Chemistry, Manufacturing and Controls (CMC)/quality and dossier

Purpose of consultancy

To provide technical expertise to the Local Production & Assistance (LPA) Unit with programme activities in strengthening local production and technology transfer for improving access to quality-assured, safe and effective in-vitro diagnostics and other medical devices.

Background

The COVID-19 pandemic has shown a concentration of global production capacity of essential health products in a few regions/countries and vulnerabilities in global supply chains. For low- and middle-income countries (LMICs) that rely largely on importation of medical products to meet public health demands, they are at greater risk for lack of access to quality-assured medical products. The LPA Unit has been receiving requests from Member States for support in strengthening quality local production and technology transfer as many LMICs look to technology transfer and strengthening local manufacturing capacity to improve timely access and strengthen national health security, particularly during emergencies such as the COVID-19 pandemic.

The Local Production and Assistance (LPA) Unit in the Regulation and Prequalification (RPQ) Department is responsible for supporting Member States in strengthening local production and technology transfer of quality-assured essential health products to improve access under the context of WHA74.6 on Strengthening local production of medicines and other health technologies to improve access and other WHA resolutions and decisions related to local production and access to health products. The focus of work is on promoting sustainable quality local production and technology transfer in a holistic manner, such as conducting feasibility assessments for sustainable local production, developing strategies, roadmaps and tools, providing capacity building and specialized technical assistance and facilitating technology transfer.

Deliverables:

The consultant will provide:

• Specialized Prequalification (PQ)-related technical assistance, for up to 10 manufacturers such as assessments/verification of the quality/CMC aspects and the dossier of vaccines and other biological/pharmaceutical products with the relevant documents (e.g. reports).
• PQ-related specialized technical assistance for up to 10 manufacturers with on-site/virtual training and/or technical assistance on the quality/CMC aspects and/or dossier of vaccines and other biological/pharmaceutical products, and the relevant documents (e.g., concept note, agenda, reports).
• Technical input for a standard operation procedure for provision of PQ-related specialized technical assistance to manufacturers of vaccines and other biological products and deliver relevant documentation (e.g. SoP document).
• On-site reviews of dossiers of vaccines and/or biological/pharmaceutical products for compliance with current WHO/international quality standards and requirements, including for WHO PQ/EUL, conducted in up to 4 countries and preparation of relevant documents (e.g. reports).
• At least 2 capacity building activities and technical assistance activities, organized and conducted for relevant stakeholders in the areas of CMC/quality, dossiers, etc. of vaccines and/or biological/pharmaceutical products with the relevant documents (e.g. concept note, agenda).
• Training materials prepared related on the quality/CMC aspects of vaccines and/or other biological/pharmaceutical products.
• Technical input on the technical products of the LPA Unit, such as ”frequently asked questions” documents, with collaboration from relevant colleagues.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree in pharmacy, sciences, life sciences or other health or socio-economic related fields.

Desirable:

• Advanced university degree related to development and/or production of vaccines and/or biological products, such as immunology, biochemistry, cellular biology or biotechnology.

Experience

Essential:

• At least seven years of relevant experience, some of which at the international level, in the production, CMC, quality control and dossier preparation for vaccines and/or biological products under current international quality standards.

Desirable:

• Relevant professional experience in the medical product manufacturing industry including:
  • Experience in the production, CMC and/or quality control of vaccines/biological products;
  • Experience in a national regulatory authority as a CMC/quality assessor of vaccines/biological products;
  • Experience with the WHO Prequalification and/or Emergency Use Listing procedures;
  • Experience in organizing and/or providing capacity building/training for quality production of medical products in low- and middle-income countries;
  • Experience in technology transfers; and/or in an international organization.

Skills/Knowledge:

Essential:

• Strong knowledge of the manufacturing processes, CMC and product dossier requirements of vaccines and biological products in accordance with WHO and/or internationally-recognized standards;
• Knowledge of current WHO and other internationally-recognized quality assurance standards, WHO emergency listing and/or prequalification procedures and/or health product regulation for vaccines and biological products;
• Ability to review, revise or develop technical documents and activities in the area of local production of medical products;
• Ability to design, plan and implement activities to achieve the goal(s);
• Excellent communication and interpersonal skills, strong planning and organizational skills and ability to use a range of IT tools (Word, Excel, presentation software, databases and web navigators;
• Demonstrated ability to interact with all stakeholders with tact and diplomacy, upholding the reputation of the Organization at all times.

Desirable:

• Knowledge of current WHO and/or other internationally recognized standards of GMP and/or quality management systems of manufacturing facilities of vaccines and biological products;
• Knowledge of technology transfers for vaccines and/or biological/pharmaceutical products;
• Knowledge of the CMC, GMP and/or product dossier requirements of medicines in accordance with WHO and/or internationally-recognized standards.

Languages required:

Essential

• Expert knowledge of English.

Desirable

• Working knowledge of another WHO official language.

Location

Off-site: Home based.

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level B-USD 7,000 - 9,980 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

2-11 months.

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html