U.S. Pharmacopeial Convention Jobs

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The U.S. Pharmacopeial Convention (USP) Vaccines Program Director in Rockville, Maryland

Description

The Vaccines Program Director, is responsible for the development and implementation of the USP Global Health strategy on vaccines. The individual provides oversight for all vaccine related activities including but not limited to manufacturing, regulatory approval, supply chain and surveillance. This role is key in

  • Organizing and delivering internal technical assistance on vaccine-related topics to GHMS units. The success of this role will be measured through satisfaction of internal stakeholders and demand for the Director’s services.

  • Advancing USP as a thought-leader in the vaccines space. The success of this role will be measured through the development of white-papers, opinion pieces and other content that enhance the organization’s visibility and relevance, as well as representing USP in global vaccine working groups and at conferences.

The Director will play a critical role in identifying data that communicates realities of the current vaccine cold chain and manufacturing and sharing data-driven solutions that are scalable. The role will lead efforts that are also country-driven in order to address national and regional priorities.

The Director will report to the Senior Director, Global Health Technical Program, and work collaboratively across the GHMS division. In close coordination with the Promoting the Quality of Medicines Plus (PQM+) Technical Director, the role will also lead vaccine activities undertaken by the program, functioning as the accountable, global point of contact.

Roles and Responsibilities

  • Provides technical leadership and coordination for all USP’s Global Health vaccines related activities including quality assurance, manufacturing, and regulatory systems strengthening.

  • Serves as subject matter expert for PQM+ work in vaccines and leads in direct implementation of all vaccines related interventions for the program.

  • Advises vaccine developers and manufacturers in formulation, chemistry, manufacturing and controls (CMC), facilities, and dossier compilation for vaccines including capacity for technology transfer and joint ventures for vaccines fill and finish capacity in LMICs.

  • Leads USP’s effort in supporting national vaccination policies, strategic plans and expanded program on immunization (EPI) and help countries navigate local initiatives and resource allocation for new vaccines deployment and transitioning out of Gavi support.

  • Manages external technical collaboration with World Health Organization (WHO), Gavi, Coalition for Epidemic Preparedness Innovations (CEPI), Developing Country Vaccine Regulators' Network (DCVRN), Developing Countries Vaccine Manufactures Network (DCVMN), African Vaccine Regulatory Forum (AVAREF), and other relevant groups.

  • Manages the development of technical approaches and tools to support USP’s activities in passive and active vaccines safety surveillance activities, facilitate the adoption of guidelines and tools from WHO’s Expert Committee on Biological Specifications, Centers for Disease Control and Prevention, Council for International Organizations of Medical Sciences and Brighton Collaboration/Task Force for Global Health.

  • Develops concepts and tools for the integration of quality and safety surveillance systems to support the deployment of new vaccines.

Basic Qualifications

  • BS in public health, biological/physical sciences, pharmaceutical science or closely related field.

  • Minimum of ten (10) years of experience in vaccine development, manufacturing, scale-up, supply-chain or regulatory affairs.

  • Demonstrated Experience engaging with and contributing to global immunization and vaccines agenda and programs from Gavi and UNICEF, and global technical norms and standards activities of WHO’s Expert Committee on Biological Specifications, and Strategic Advisory Group of Experts on Immunizations (SAGE).

  • Demonstrated success working effectively leading a multidisciplinary and international project team.

Preferred Qualifications

  • Masters Preferred

  • Demonstrated experience in EPI and national vaccine programs.

  • Expert in cold chain and vaccine supply logistics.

  • Demonstrated experience in vaccine surveillance and/or management.

  • Deep understanding of Gavi and Global Fund country graduation.

  • Excellent oral, written and presentation skills with ability to present to senior level executives and government representatives.

  • Ability to travel up to 25%.

USP offers an impressive benefits package, including:

  • Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start

  • An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately

  • Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

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 Technical Programs

Job Type Full-Time

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