Technical Advisor PQMPlus (Fixed Term) - South Africa at US Pharmacopeia

Description

Summary of the Position
The Technical Advisor is a subject matter expert in vaccines and is responsible for the implementation of PQM+ technical assistance activities for COVID-19 vaccine manufacturing and regulation. S/He will report to the in-country Chief of Party or his/her designee and will work under technical guidance and oversight from the HQ-based Vaccines Director. The Technical Advisor will provide support to local manufacturers of vaccines in Africa in technology transfer and will help build national regulatory capacity for vaccines as well as the workforce competency for biologics and vaccines quality assurance. The successful candidate will provide technical assistance on fill/finish and packaging processes for COVID-19 vaccines. S/He will serve as a subject matter expert using knowledge to ensure cGMP compliance, fulfillment of technical requirements and regulatory guidelines as they relate to fill/finish and packaging equipment, materials, facilities, and process development. In fulfillment of the role, the incumbent will collaborate with other USP and PQM+ staff, USP’s Global Biologics Division, local manufacturers, and vaccine regulators.

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
• Ten (10) 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
• 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