United States Pharmacopeia

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.. The incumbent works in close coordination with USP scientists and editorial staff, as well as French-speaking scientists, reviewers, translators, technical editorial personnel, and a French Translation Working Group of different expert scientific stakeholders to resolve issues with respect to scientific validity and technical aspects of the pharmacopeial and related content.. 8 years of hands-on experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titrimetry, required.. Knowledge of compendial standards related to the pharmaceutical industry in the African Medicines Agency, but also in the United States, is strongly preferred, as well as knowledge of international regulatory requirements and guidelines for pharmaceutical, dietary supplements.. Familiarity with areas of scientific knowledge relevant to pharmacopeial work including biologic drugs, excipients, active pharmaceutical ingredients, dietary supplements, analytical and pharmaceutical manufacturing instrumentation, quality control, regulatory science, basic statistics, metrology.

senior scientist i

Who is USP? 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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. Brief Job Overview This is a non-supervisory, full-time, hybrid, deadline-driven position based in Rockville, MD (DMV area). The incumbent will be responsible for performing scientific review of translated technical content. The function requires critical evaluation of pharmacopeial documents as well as any other necessary content translated from English into French to ensure technical accuracy, quality, clarity, and consistency. The incumbent works in close coordination with USP scientists and editorial staff, as well as French-speaking scientists, reviewers, translators, technical editorial personnel, and a French Translation Working Group of different expert scientific stakeholders to resolve issues with respect to scientific validity and technical aspects of the pharmacopeial and related content. The incumbent searches relevant scientific and regulatory documentation to justify adequacy of translated pharmacopeial content and its scientific relevance to target audience. How will YOU create impact here at USP? This is a new role at USP, where the candidate will participate in the development of a new product intended to expand access to USP standards globally with a French translation of the USP-NF. The translation will directly support the USP Africa Strategy by bringing accessible content to Francophone countries. The initiative will help support health equity in Africa and provide access to the compendia in other French-speaking countries, contributing to capability building and quality in the pharma industry. Who USP is Looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: •Doctorate in Chemistry, Biochemistry, Pharmacy, or related fields with a minimum of 8 years' experience, or M.S. and 10, or B.S. and 15 years of relevant experience with following pharmacopeial regulations required. •8 years of hands-on experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titrimetry, required. •Knowledge of compendial standards related to the pharmaceutical industry in the African Medicines Agency, but also in the United States, is strongly preferred, as well as knowledge of international regulatory requirements and guidelines for pharmaceutical, dietary supplements. (e.g., FDA, ICH, etc.). •Participates in planning the stages of the scientific review. •Excellent written and verbal communication skills in French and English (MUST BE FLUENT IN BOTH) •Coordinates the scientific review workflow with external French-speaking consultants; serves as a point of contact and interactions with contractors. •Independently edits and proofreads USP pharmacopeial content and any supporting documentation translated into French with minimum supervision to ensure scientific accuracy, quality, and clarity of the translated text. •Searches scientific and regulatory literature in French and English to resolve scientific and compendial language consistency issues. •Compiles new entries for inclusion into the English-French scientific glossary and co-maintains the Style Guide and USP French Glossary. •Maintains the French Errata system and submits English and French errata. •Coordinates and leads meetings of the USP staff and relevant French-language associates, identifies key issues for discussion, compiles agenda and notes, and delivers presentations on assigned topics. •Trains French-speaking scientists. •Identifies potential scientific and regulatory content experts in relevant areas of expertise, establishes and maintains relationships, and ensures strict adherence to USP Conflict of Interest and Code of Ethics requirements. Additional Desired Preferences: •Strong presentation skills, both written and oral. •Familiarity with and ongoing education on the normative pharmaceutical and regulatory documentation issued by the relevant United States, international and French regulatory agencies. •Ability to reconcile specialized scientific and pharmacopeial terminology in English and French. •Adequate command of chemistry, chemical nomenclature, analytical techniques, and methodologies, and understanding of basic pharmaceutical manufacturing operations. •Familiarity with areas of scientific knowledge relevant to pharmacopeial work including biologic drugs, excipients, active pharmaceutical ingredients, dietary supplements, analytical and pharmaceutical manufacturing instrumentation, quality control, regulatory science, basic statistics, metrology. •Capacity to undertake in-depth investigations, comprehend and critically assess complex data to reach reliable and defendable conclusions about scientific English-French translated documents. •Ability to work in an environment guided by numerous highly technical, written requirements and instructions, closely following workplace policies. •Ability to work independently to obtain results necessary for completing assigned tasks. •Ability to withstand the pressure of tight deadlines in a multi-tasking work environment. •Ability to efficiently communicate technical information to non-technical and non-scientific staff. •Excellent organizational, project management and detail-oriented skills. Supervisory Responsibilities None. Benefits 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 is protected. COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired): As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work-from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Note: 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)

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