CALL FOR BIOSAFETY AND BIOSECURITY EXPERT - Military Veterans
at US Pharmacopeia
Description
The U.S. Pharmacopeial Convention (USP ) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality and efficacious medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medicines and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
USP seeks eligible candidates with expertise in one or more of the technical areas of interest below to be included in a proposal to USAID for an emerging infectious disease global opportunity. This job posting does not guarantee employment. This potential work would be completed under the guidance of USP’s Global Public Health (GPH) division.
TECHNICAL AREAS OF INTEREST
USP is seeking a Chemistry, Manufacturing and Control (CMC) Technical Advisor for East Africa. The successful candidate will lead technical assistance efforts aimed at increasing the supply of quality-assured essential medical products in East Africa and other regions across the continent. This position involves collaborating with manufacturers and regulators, providing technical guidance, facilitating technology transfers of therapeutics, and ensuring compliance with international standards.
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.
APPLICATION SUBMISSION REQUIREMENTS
Please send your CV to newbusiness@usp.org by the 07/30/2024. When submitting your application, write “Call for CMC ” in the email Subject Line. If you are applying for more than one Technical Area of Interest, please specify in the email Subject Line.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time
Nairobi, Nairobi County
US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820. We are a public health organization that uses rigorous science and public quality standards setting to protect patient safety and improve global health. We are committed to building public trust and confidence in drug therapies to enable people to live longer and healthier, and also work to building trust in dietary supplements and food ingredients. Currently, we are working to strengthen the global supply chain so that the medicines people rely on are available when needed and work as expected. Our Volunteers USP standards are in a continuous process of review and revision based upon new evidence, emerging public health concerns, and public requests for revision. Input from our volunteers, through our Council of Experts and Expert Committees and Panels, is crucial for maintaining our standards and preserving public trust. Our Governing Bodies The USP Convention helps guide our areas of impact – nearly 500 Member Organizations from around the world contribute valuable perspectives, experiences, and expertise from across healthcare and science. In addition to collaborating on critical healthcare and science matters, every five years, Convention Members adopt USP Resolutions and elect USP’s Board of Trustees and the Council of Experts who lead USP’s standards-setting Expert Committees.