The U.S. Pharmacopeial Convention (USP) (Senior) Principal Scientist, General Chapters- Complex Generics in Rockville, Maryland
Summary of the Position
This position is a professional hands-on, highly technical role that supports the standard-setting activities of the USP-NF. The incumbent is responsible for revising and developing new USP chapters associated with complex generics working in close collaboration with USP’s Expert Committees.
Roles and Responsibilities
• Develop a vision and roadmap for Complex Generics.
• Lead cross-functional groups to focus efforts on specific knowledge domains and high-impact topics.
• Determine deliverables, requirements, and timelines for the development of Complex Generics standards and solutions.
• Execute against the standards and solutions roadmap through tight integration of activities within USP and with external stakeholders, including but not limited to industry, academia, and regulators.
• Advocate for Complex Generics development to support the generic pharmaceutical industry and use of USP standards and solutions across the broader scientific and regulatory communities.
• Maintain awareness of the current trends and issues in the industry by attending scientific seminars, conferences, industry consortia meetings, and other fora.
• Represent USP science and standards at industry conferences and symposia as well as through written articles.
• Lead internal and external Complex Generics capability-building activities, including training, education, and knowledge-sharing across the organization.
• Ph.D. degree in Organic, Analytical, Pharmaceutical Chemistry or a related field and 10 years, or M.S. and 12 years of relevant experience with USP-NF test and standards required.
• Minimum of 8 years of experience with Complex Generics testing (Injectables, topical or transdermal, Inhalation and other complex formulations) working in the pharmaceutical industry.
Senior Principal Scientist:
• Ph.D. degree in Organic, Analytical, Pharmaceutical Chemistry or a related field and 13 years of relevant experience with USP-NF test and standards required.
• Minimum of 10 years of experience with Complex Generics testing (Injectables, topical or transdermal, Inhalation and other complex formulations) working in the pharmaceutical industry.
• Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of pharmaceutical products.
• Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Able to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
• Strong presentation and communication skills (written and oral).
• Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
• Knowledge of internet and electronic database searches helpful
• Practical experience in scientific, analytical techniques.
• Project Management skills required.
• Knowledge of the pharmaceutical industry and the associated regulatory framework is essential. Ability to prioritize tasks and manage multiple projects simultaneously.
• Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions.
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 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
The following COVID-19 provisions will apply to selected candidate(s) hired:
As a condition of employment with United States Pharmacopeial Convention’s (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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time