Users and Survivors of Psychiatry in Kenya (USP Kenya) welcomes all members of the public and relevant stakeholders to be partners in promoting the human rights discourse of persons with psychosocial disabilities.

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.