Scientist III/Senior Scientist III/Scientist IV (1150-679)
This is a key hands-on, non-supervisory position in USP’s Reference Standards Laboratory. In this role, the Scientist III/Sr. III/IV conducts routine and non-routine analyses of raw materials, reference standards, and stability samples by appropriate analytical methods. The Scientist III/Sr. III/IV works on technical problems in analytical chemistry that directly support revisions to the USP-NF, including the evaluation of candidate reference standards, the evaluation of methods, development/modification or validation of official methods, troubleshooting of equipment, the evaluation of packaging materials, and other general research in analytical chemistry. The Scientist III/Sr. III/IV serves as a technical resource for a variety of analytical techniques for RSL staff. The Scientist III/Sr. III/IV may execute 90% - 100% of their work at the bench level.Roles and Responsibilities
- Acts as a technical leader in reference standard/monograph procedure evaluation, and problem solving of complex projects. Provides hands-on and theoretical training to the laboratory staff as appropriate.
- Perform laboratory work as necessary for the testing of monograph procedures, reference standard evaluation and any additional experiments as needed for the development/optimization of monograph procedures.
- Reviews and approves documentation including raw data, protocols, methods, and reports.
- Provides guidance to development teams on optimum monograph procedure development approaches and potential problems.
- Proposes and design studies to obtain necessary data to resolve concerns.
- Oversees and coordinates all aspects of the projects from receipt of the work request, to final release of project reports.
- Support lab management with project assignments, task prioritizations and resource allocation.
- Addresses customer technical inquiries and thoroughly investigate customer concerns when necessary.
- Keeps abreast of current trends and developments in related scientific fields. Evaluates risks/benefits and supports the establishment of new technologies within RSL to sustain customer’s technical requirements.
- Presents technical issues/presentations to inter-departmental USP staff.
- Facilitates additional cross-functional activities with other USP staff.
- Communicates with other USP departments regarding any problems encountered during the testing of reference standards and monograph procedures.
- Serves as representative of USP at professional meetings.
Ph.D. in Science and 0 years of relevant laboratory experience, or
M.S. in Science and 5 years of relevant laboratory experience, or
B.A. /B.S. in Science and 7 years of relevant laboratory experience.
Senior Scientist III:
Ph.D. in Science and 2 years of relevant laboratory experience, or
Ph.D. in Science and 5 years of relevant laboratory experience, or
M.S. in Science and 7 years of relevant laboratory experience, or
B.A. /B.S. in Science and 10 years of relevant laboratory experience.Preferred Qualifications
- Proficient with testing involving compendial methods for raw materials (USP, BP, EP, etc.).
- Expert in HPLC and GC method development, testing and troubleshooting; and proficient in other related analytical instrumentation (e.g., FTIR, LOD, AA, KF, UV).
- Takes personal responsibility to ensure work is delivered on time and is the highest possible quality.
- Skill to anticipate, troubleshoot, and solve technical problems.
- Plans and conducts minor modifications to monograph methods independently and in consultation with Scientific Liaisons and References standard Scientists.
- Experience in using chromatography software such as Empower or Agilent and Electronic laboratory Notebook is a plus.
- Ability to prioritize tasks and manage multiple projects simultaneously.
- Knowledge of pharmaceutical industry and the associated regulatory framework is desirable. Experience with, and knowledge of compendia operation is preferred.
- Ability to lead projects to completion with a high degree of scientific expertise.
- Excellent communication and presentation skills, both verbal and written.
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