Reference Standards Scientist III/IV (1093-679)
This is a hands-on, non-supervisory position in the Reference Standards Evaluation (RSE) Department within Global Laboratory Operations (GLO). The incumbent is responsible for designing and writing the reference standards qualification test protocols and Reference Standard Candidate Evaluation Packages (RSCEPs) in support of reference standards for use in USP monographs, conducting any investigations based on customer complaints and internal findings, prepare Reference Standard Certificate, Packaging Configuration Forms. This position is a component of USP’s core business and the incumbent is expected to support departmental quality initiatives.
This position reports to the Manager, Reference Standards Evaluation, and interacts on a regular basis with other Reference Standard Scientists and Managers, Reference Standard Technical Operations staff, Reference Material Support (RMS) staff, Reference Materials Acquisition staff, QA, Reference Standards Laboratory staff, Reference Standards Portfolio Management, Scientific Liaisons, and Reference Standards Production (RSP) staff attends Expert Committee meetings, Reference Standards Ballot meetings as needed.
Roles and Responsibilities:
- Designs collaborative studies and prepares test protocols/documents for reference standard candidates in accordance with established SOP’s, Operation Manuals, and policies. The incumbent will be responsible for ensuring the protocols contain sufficient and appropriate identity and purity tests to properly characterize reference standard candidates.
- Evaluates collaborative study data for potential candidate materials with regard to their suitability for use in USP-NF compendia
- Authors the Reference Standards Candidate Evaluation Packages (RSCEPs) in accordance with established SOP’s, Operation Manuals, and training documents
- Works professionally and collaboratively with fellow Reference Standard Scientists, Reference Standards Technical Operations staff, Reference Standards Laboratory staff, Scientific Liaisons, Reference Standards Production staff, Reference Materials Acquisition staff, and other relevant departments as required.
- Identifies and implements solutions to technical problems related to the development of reference standards and the analysis of the data.
- Assists in quality related investigations resulting from customer complaints to include root cause analysis, corrective action identification, action planning, and implementation monitoring
- Prepares technical presentations as needed for reference standard investigations and expert committee meetings
- Performs other duties as assigned
Scientist III: MS in Chemistry or a related field with at least 5 years of relevant experience in pharmaceutical industry or Ph.D. in Chemistry or a related field. Knowledge of analytical techniques employed for the analysis of drug substances, drug products, impurities, etc.
Scientist IV: MS in Chemistry or a related field with at least 7 years of relevant experience in pharmaceutical industry or Ph.D. in Chemistry or a related field with at least 5 of years of relevant pharmaceutical industry experience. Knowledge of analytical techniques employed for the analysis of drug substances, drug products, impurities, etc.
- Pharmaceutical industry experience working in the area of drug development in a compliance environment
- Prior knowledge of working with and/or qualifying reference standards for drug substances and drug products
- Working knowledge and/or experience of solid state characterization techniques
- Excellent written and verbal communications skills
- Proven ability to write scientific / technical documents (protocols, reports, investigations etc.)
- Ability to work collaboratively with other functions and desire to work well with diverse employees in a professional manner
- Ability to operate independently where appropriate, yet understand when to escalate issues and how to establish effective working relationships
- Ability to prioritize tasks and manage multiple projects simultaneously
- Ability to handle multiple 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 offers an impressive benefits package, including:
- Generous paid time off – 13 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 ($250/individual or $500/family)
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 1,000 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.
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.Job Location Rockville, Maryland, United States Position Type Full-Time/Regular