Scientist II, Dosage Form Performance Lab (918-679)
This is a non-supervisory, technical position responsible for the coordination of activities related to the development of specific methods utilized to assess proper performance of various dissolution/drug release test apparatus (also called Performance Verification Tests). This work requires expertise in dosage form performance testing (i.e. dissolution/drug release tests), as well as a full application of sound scientific principles, theories, concepts, and techniques. The incumbent is expected to collect information and develop solutions to specific projects.
Roles and Responsibilities:
- Works under limited supervision to develop in vitro methodologies for the performance verification tests for various dissolution instruments;
- Perform all experimental activities required to support the current reference materials program;
- Recommends the utilization of results or changes in the scope of work or termination of projects;
- Interprets generated data with little or no assistance; explains results to others
- Troubleshoots common lab problems independently; seeks assistance with difficult/unusual lab problems.
- Performs investigations in the lab as needed;
- Develops and validates analytical methods;
- Utilizes routine and non-routine instrumental methods to identify superior formulation and investigate formulation issues;
- Coordinates activities among the team members and communicates results of work;
- Assists in planning of research and development required for all projects;
- Prepares and presents oral and written reports to team, department, or USP;
- Trains less experienced staff in various aspects of research.
MS in pharmaceutical science or a related field and 2 years of relevant industry experience, or a BA/BS and 4 years of industry experience.
At least 2 years of experience in dissolution/ drug release testing is required.
- Experience in the pharmaceutical industry is required with specific expertise in dissolution/ drug release testing.
- Knowledge of quality and performance testing of various dosage forms and of pharmaceutical regulations desired.
- Working knowledge of MS Office software.
- Must have the ability to plan and conduct research independently.
- Commitment to and knowledge of maintaining a safe laboratory environment.
- Demonstrated teamwork skills, excellent analytical abilities, and good written and verbal communication skills are a must.
- Experience in pharmaceutical production, development, or other activities related to pharmaceutical drug products is of advantage.
- Familiarity with the cGMP and/or ISO requirements for test laboratories.
- Must possess the ability to multi-task and to work effectively with a team.
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