Senior Technical Advisor - Regional PQMPlus (FIXED-TERM) 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