job description - Technical Advisor, PQMPlus
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
Benefits
- USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
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U.S. Pharmacopeial Convention (USP) is a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.