Technical Advisor, PQMPlusU.S. Pharmacopeial Convention (USP)

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 the 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 the 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 technology and communication materials related to local manufacturing and the 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.

Preferred Qualifications:

• Master of Science or Ph.D. 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.

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.

Benefits

• USP provides you with the benefits you need to protect yourself and your family today and tomorrow.
• From company-paid time off, and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.