E-DRUG: Job openings at The U.S. Pharmacopeial Convention in Rockville, MD, USA.
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Hello - below are three job opportunities at The U.S. Pharmacopeial Convention in Rockville, MD, USA. All will require at least 25% international travel. Interested parties can apply through our website www.usp.jobs<http://www.usp.jobs>
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. Being a part of USP means belonging to a diverse culture made up of more than 800 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
Program Manager, Asia
This is non-supervisory program management position in which the incumbent works as part of a team to design and develop specific health and pharmaceutical programs in countries or regions for USP's United States Agency for International Development (USAID) cooperative agreement, and develops other contracts or grants for work in developing countries. Develops training materials and/or provides training for country project participants. Analyzes drug quality data; prepares publications and reports. This individual will communicate with USAID and other funding sources as required. The position is based in USP's corporate headquarters in Rockville, MD, and focuses on Asia and Near-East.
Position requires PharmD and one year of experience in a related field or Master of Public Health or Master of Science in Chemistry or a related field and three years of relevant experience, including strong international experience. An equivalent combination of experience and education may be substituted. Experience with quality assurance/quality control of pharmaceuticals required. Extensive knowledge of USAID programs, projects, and grant administration is required. Experience working with the World Health Organization (WHO) and/or other international organizations a plus as is knowledge of public health issues in developing countries, especially in Asia and Near-East Region in the areas of HIV, TB, and Malaria as well as knowledge of other major pandemics. Demonstrated abilities to develop training materials on pharmaceutical quality assurance and/or quality control and deliver them successfully at national and international arenas is required.
www.usp.jobs<http://www.usp.jobs>
Sr. GMP Specialist
This is a hands-on, non-supervisory position where the incumbent understands the standards and principles of auditing manufacturing facilities for current good manufacturing practice (cGMP) compliance. The incumbent will analyze all elements of a quality system and judging its degree of compliance with the criteria of quality management, evaluation and control systems. The individual leads companies in compiling dossiers for World Health Organization (WHO) prequalification's CTD and other dossiers. The incumbent establishes manufacturing, QA, QC process, and documentation requirements for WHO prequalification, and other regulatory programs. He/she partners with the director in the evaluation of cGMP, QA, and manufacturing batch records received from manufacturers. Contributes to qualify pharmaceutical manufacturers for essential drugs supply chain management as well as for generic industry for affordable drugs worldwide.
Position requires a Bachelor's degree in Science and a minimum of seven (7) years of work experience in the pharmaceutical industry and/or government drug regulatory authority. Hands-on manufacturing experience with tablet, capsule and parental pharmaceutical products is strongly preferred. A minimum of five years of experience in at least two of the following: pharmaceutical CGMP compliance, pharmaceutical supply chain management, pharmacology, medicines evaluation is required.
Must have knowledge in CGMP drug development to commercialization and knowledge of developing countries for both public health sector and generic pharmaceutical market including testing and manufacturing. Experience working for WHO prequalification program to assess dossiers and conduct GMP inspections and familiarity with WHO Common Technical Document (CTD) format for dossiers preferred. Excellent verbal, written and presentation skills; grant writing experience helpful. Ability to network with professionals from WHO, UNICEF, UNIDO, USFDA, EDQM, EMA, GDF, Global Fund and other donor foundations as well as local in-country representatives and government officials. Language skills a plus (English, Spanish, French, Arabic or Mandarin).
www.usp.jobs<http://www.usp.jobs>
Manager, Africa Programs
This supervisory position supports the Global Health Impact Programs (GHIP) department by managing activities of the Promoting the Quality of Medicines (PQM) cooperative agreement between USP and the U.S. Agency for International Development (USAID) for USAID targeted African countries. This role manages PQM staff in developing appropriate activities to address the quality of medicines in USAID targeted African countries. This individual provides direct technical leadership to improve pharmaceutical quality assurance systems while working with stakeholders.
Must have a Master's degree in pharmaceutical sciences, public health, or related field and a minimum of 10 years of professional experience in public health in developing countries; minimum of five years of supervisory experience. Prior experience in a scientific based industry and knowledge of cGMP in the pharmaceutical manufacturing industry required. USAID experience preferred.
www.usp.jobs<http://www.usp.jobs>
Kim Beachley, SPHR, CIR
Manager, Talent Acquisition
U.S. Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD 20852-1790
301-230-6328 Office 301-704-1321 Mobile
"Kimberly J. Beachley" <KJB@usp.org>