Call for Biosafety and Biosecurity Expert at US Pharmacopeia

Potential tasks that the CMC may be responsible for carrying out include:

• Lead in the provision of technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products.
• Provide technical assistance to manufacturers in GMP, technology transfer, and dossier development and submission through audits, trainings, and deployment of tools and approaches to ensure adoption of international quality standards.
• Conduct audits to assess compliance with international standards from WHO prequalification process and support manufacturers to develop strategies and tools to address deviations and non-compliance identified.
• Identify CMC risks and support the development of mitigations and contingency plans.
• Provides oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support.
• Actively contribute to the engagement of the private sector stakeholders to facilitate public-private collaboration to support local manufacturing of quality pharmaceuticals and medical products.
• Work closely with teams to support development and deployment of strategies.
• Review and provide timely inputs into key project deliverables including technical and donor reports.

Qualifications

• Minimum of 10 years of experience in pharmaceutical manufacturing.
• Subject matter expert in manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings.
• Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for medicines, packaging, and other relevant areas.
• Knowledge of regulatory requirements related to the development and manufacture of medicines in all phases of clinical development.
• Direct experience with regulatory authority registration processes.
• BS, MS, or Ph.D. degree in, pharmaceutical science, chemistry, engineering, or science related field of study required.
• Strong written (especially technical writing) and oral communication skills
• Willingness to travel.
• Fluency in English is required. Fluency in French is a plus.