The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality and efficacious 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 work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medicines 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 seeks eligible candidates with expertise in one or more of the technical areas of interest below to be included in a proposal to USAID for an emerging infectious disease global opportunity. This job posting does not guarantee employment. This potential work would be completed under the guidance of USP’s Global Public Health (GPH) division.
TECHNICAL AREAS OF INTEREST
USP is seeking a Chemistry, Manufacturing and Control (CMC) Technical Advisor for East Africa. The successful candidate will lead technical assistance efforts aimed at increasing the supply of quality-assured essential medical products in East Africa and other regions across the continent. This position involves collaborating with manufacturers and regulators, providing technical guidance, facilitating technology transfers of therapeutics, and ensuring compliance with international standards.
Potential tasks that the CMC may be responsible for carrying out include:
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Lead in the provision of technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products.
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Provide technical assistance to manufacturers in GMP, technology transfer, and dossier development and submission through audits, trainings, and deployment of tools and approaches to ensure adoption of international quality standards.
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Conduct audits to assess compliance with international standards from WHO prequalification process and support manufacturers to develop strategies and tools to address deviations and non-compliance identified.
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Identify CMC risks and support the development of mitigations and contingency plans.
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Provides oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support.
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Actively contribute to the engagement of the private sector stakeholders to facilitate public-private collaboration to support local manufacturing of quality pharmaceuticals and medical products.
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Work closely with teams to support development and deployment of strategies.
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Review and provide timely inputs into key project deliverables including technical and donor reports.
Qualifications
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Minimum of 10 years of experience in pharmaceutical manufacturing.
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Subject matter expert in manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings.
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Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for medicines, packaging, and other relevant areas.
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Knowledge of regulatory requirements related to the development and manufacture of medicines in all phases of clinical development.
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Direct experience with regulatory authority registration processes.
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BS, MS, or Ph.D. degree in, pharmaceutical science, chemistry, engineering, or science related field of study required.
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Strong written (especially technical writing) and oral communication skills
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Willingness to travel.
- Fluency in English is required. Fluency in French is a plus.
APPLICATION SUBMISSION REQUIREMENTS
Please send your CV to newbusiness@usp.org by the 07/30/2024. When submitting your application, write “Call for CMC” in the email Subject Line. If you are applying for more than one Technical Area of Interest, please specify in the email Subject Line.