Summary of the Position
- This is a non-supervisory position and is an individual contributor role
- This a strategic level position in order to expand competencies and capabilities in medical products manufacturing
- The incumbent will be responsible for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products
- The incumbent will interface with internal USP departments as well as manufacturers of medical products and regulators
Roles and Responsibilities
- 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.
- Supports the work and efforts of the Lead Pharmaceutical Product Supplies to develop technical documents, tools on localizing manufacturing of medical products in LMIC
- Collaborate with PQM+ to provide technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products.
- Provides oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support
- Identify CMC risks and support the development of mitigations and contingency plans.
- 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.
- 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
- Keep abreast of the latest manufacturing trends and regulation requirements
- Recognized leader actively advancing and deploying new technologies and trends in manufacturing
- Represents USP in international forums on manufacturing
- Minimum of 5 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 up to 25% of the time
- Experience in at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
- Experience with including water systems, sterility, HVAC, contamination, analytical chemistry, cleaning procedures, validation, formulations, and other relevant areas
- Understanding of global dynamics impacting the supply of quality-assured pharmaceuticals and medical products
- Direct experience with and understanding of WHO pre-qualification and/or other regulatory authority registration processes
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.
The following COVID-19 provisions will apply to selected candidate(s) hired:
As a condition of employment with United States Pharmacopeial Conventions (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time