The U.S. Pharmacopeial Convention (USP) Senior Scientist I, CRM (Certified Reference Materials) in Rockville, Maryland
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 position in Reference Standard Evaluation (RSE) department, responsible for oversight and successful implementation and completion of all activities pertaining to a portfolio of Certified Reference Materials (CRMs) or any other physical materials USP intend to develop. This incumbent is responsible for coordination of activities related to CRMs, including but not limited to, timely preparation of strategy on developing CRMs, assessment of commercially available CRMs for use as primary CRMs, preparing production planning documents, reference materials procurement specifications, ensuring reference materials are suitable for development as CRMs, providing technical assistance during methods development and validation of methods for CRM testing, analytical data review, review of technical documentation including but limited to characterization evaluation reports, homogeneity reports, statistical reports, assessment of uncertainty, review of Certificate of Analysis, resolving technical issues.
How will YOU create impact here at USP?
The position is expected to contribute to all activities related to production of CRMs and any other physical reference materials.
• Responsible for managing the development of CRMs by working in collaboration with internal and external stakeholders/partners as necessary.
• Ensuring compliance with ISO standard 17034, Guide 35, Guide 31 etc.
• Reviewing the data package from suppliers, authoring and/or reviewing production planning document packaging, labeling, and sampling forms, CRM characterization reports, statistical reports, uncertainty calculations etc.
• Assessing commercially available CRMs for use as calibrants and candidate reference materials to determine suitability as CRMs.
• Preparing and/or reviewing the documentation including, but not limited to, the test protocols, report, certificate of analysis etc.
• Communicating with internal stakeholders and external partners as required.
• Addressing customer queries and complaints promptly after doing necessary investigation.
• To have the ability to do “problem solving” at any step of development process.
• Performs and participate in other related duties as assigned.
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:
• Ph. D. in Chemistry or related field with a minimum of 5 years working on Certified Reference Materials.
• MS or BS in Chemistry or related field with a minimum 10 or 15 years, respectively, working on Certified Reference Materials.
Additional Desired Preferences
• Thorough understanding of ISO standards and guides related to development of CRMs. ISO standards and guides include but not limited to ISO 9001, ISO 17025, ISO 17034, Guide 35, Guide 31, Guide to the expression of uncertainty measurement, developing and measuring uncertainty models and any other related CRM ISO standards and guides.
• Accreditation requirements from various accreditation bodies for Certified Reference Materials producers.
• Basic knowledge / familiarity with statistical analysis.
• Thorough understanding commonly used analytical techniques such HPLC, GC, IR, MS, NMR etc.
• Ability to read and interpret spectroscopic analyses data (NMR, IR, MS).
• Excellent written and verbal communications skills.
• Ability to operate independently where appropriate yet understand when to escalate issues and how to establish effective working relationships.
• Project Management skills. Must have ability to prioritize and manage multiple, concurrent projects in a fast-paced and high-volume environment with changing deadlines and priorities.
• Able to work flexible hours when needed to meet the project timelines.
• Strong skills in troubleshooting and solving technical problems.
• Experience with, and knowledge of the USP-NF is preferred.
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)
Job Category Chemistry & Scientific Standards
Job Type Full-Time