Openings at US Pharmacopeia

Roles and Responsibilities

• Lead and coordinate the technical development and implementation of in-country COVID-19 vaccine manufacturing and regulatory work plan activities
• Provide technical assistance to COVID-19 mRNA vaccines manufacturers on development, commissioning, qualification and validation of vaccine fill/finish and packaging processes.
• Partner with USP and PQM+ technical team members, consultants, other PQM+ countries, vendors, and local stakeholders to assure adequate manufacturing facility design and startup.
• Provide support to strengthen the National Medicines Regulatory Authority (NMRA) legal framework for vaccines manufacturing, supply, storage, distribution, and handling
• Support NMRA and national control labs in the development of lot release testing capacity and in the implementation of vaccine post-marketing surveillance. Also support the GMP inspectorate of the NMRA to strengthen its capacity for regulatory oversight of vaccine manufacturers.
• Liaise with HQ Vaccines Director to develop appropriate training materials and to organize the delivery of training programs targeted to local vaccine manufacturers, regulators, and quality laboratory staff.
• Support manufacturers in addressing deviations and non-compliances, in conducting audits to assess compliance and the establishment of cGMPs; also, in filing of vaccine dossiers for market authorization according to NMRA’s requirements.
• Coordinate efforts aimed at the identification of needs for manufacturing and laboratory equipment, materials, and processes in support to successful local production and quality assurance of COVID-19 vaccines.
• Support manufacturers to identify chemistry, manufacturing, and controls (CMC) risks and continuous improvement opportunities
• Gather programmatic data and develop progress reports as guided by the PQM+ HQ Vaccines Director. Also, support the development of technical and communication materials related to local manufacturing and quality of vaccines.

Basic Qualifications

• Bachelor of Science degree in pharmacy, pharmaceutical science, chemistry, biochemistry, engineering, or science related field of study required
• Twelve (12) years of experience in vaccines and biologics manufacturing or regulation
• Skills Sought
• Subject matter expert in vaccine/biopharmaceutical fill/finish and packaging processes
• Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for vaccines and medicines e.g., fill and finish
• Knowledge of regulatory requirements related to the development and manufacture of biologics
• Strong technical writing and oral communication skills
• Proficiency in French
• Willingness to travel up to 25% of the time

Preferred Qualifications

• Master of Science or PhD in pharmacy, pharmaceutical science, chemistry, biochemistry, engineering, or science related field of study
• Understanding of GMP manufacturing of biologics, including vaccines
• Understanding of compatibility and stability studies
• Understanding of cold chain monitoring
• Understanding of fill/finish and packaging processes for mRNA vaccines
• Direct experience with and understanding of WHO vaccine pre-qualification and/or other regulatory authority registration processes

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Roles And Responsibilities

• PQM+ regulatory systems strengthening lead in the Africa region
• Leads in the development of medicines regulatory policies impacting medicine quality and will work with the heads of NMRAs and MoH to develop policies to strengthen the pharmaceutical sector in Africa
• Identifies gaps in key medicines regulatory functions and recommends areas of improvement
• Provides guidance in the development and implementation of institutional development plans to address findings from WHO Global Bench-marking Assessment Tool (GBT)
• Identifies regulatory gaps related to access to medicines, and develop activities to address the gaps
• Leads in organizational and human capacity building efforts across select medicines regulatory functions
• Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge
• Liaises with medicines regulatory authorities to facilitate information sharing related to medicine quality assurance of medical products
• Contributes to the development of global strategies and documentation of best approaches and practices that promote the PQM+ program visibility
• Supports the PQM+ program team in work plan development and implementation
• Provides oversight for local RSS staff, local partners and consultants involved in the regulation of medical products
• Actively collaborates with the Africa regional harmonization initiatives e.g. the African Medicines Regulatory Harmonization (AMRH) Initiative, Africa Medical Devices Forum (AMDF), African Medicines West African Health Organization (WAHO) and other initiatives in the regions
• Prepares and shares analytical results and insights with national medicines regulatory authorities, ministries of health and local USAID missions.
• Actively contributes to annual programmatic and resource planning process and to the development of quarterly and annual reports

Basic Qualifications

• Ten (10) years’ experience working in pharmaceutical regulatory affairs in at least one of the following regulatory functions – registration/market authorization, post-market surveillance, and inspections
• Working knowledge and understanding of regulatory systems strengthening in countries in Africa
• S. in pharmacy, pharmaceutical science, chemistry, engineering, or science related field of study required

Preferred Qualifications

• Strong written (especially technical writing) and oral communication skills
• Direct experience with and understanding of WHO global benchmarking tool
• Fluent in French
• Willingness to travel at least 30% of the time