Scientist III

USP•Rockville, MD

About The Position

This is a hands-on, non-supervisory individual contributor position in USP’s Reference Standards Laboratory. The Scientist III provides technical assistance to collaborative testing and the continued suitability for use program by performing analytical tests, reviewing analytical data, and preparing summary reports. The role may involve spending 90%–100% of work time at the bench. The position performs routine drug release testing and chemical analysis on developmental formulations and candidate reference materials; participates in cross-functional reference-standard development; researches pharmaceutical dosage-form testing and characterization; and supports staff training. Other work includes defining project processes, implementing data systems, assessing protocols, developing and validating methods, coordinating projects, reporting results, troubleshooting methods and instruments, and leading investigations and corrective actions. The role also provides technical support to internal and external stakeholders, mentors laboratory scientists, presents scientific work, evaluates scientific literature, and recommends laboratory equipment purchases.

Requirements

Ph.D. in Chemistry or a related field; or a master’s degree in Chemistry or a related field and 5 years of experience evaluating drug product performance and quality; or a bachelor’s degree in Chemistry or a related field and 10 years of experience evaluating drug product performance and quality.
Familiarity with cGMP and/or ISO requirements for testing laboratories.
Research experience in dosage-form characterization and in vitro testing.
Ability to plan and conduct research independently.
Excellent verbal and written communication and presentation skills.
Proficiency in drug-release and product testing involving compendial methods such as USP, BP, and EP.
Ability to take personal responsibility for delivering high-quality work on time.
Ability to anticipate, troubleshoot, and solve technical problems.
Ability to build technical expertise in others through role modeling and positive influence.
Analytical and multitasking abilities.

Nice To Haves

Previous project management experience.
Experience and a proven track record of introducing new or innovative technologies into a laboratory.

Responsibilities

Perform routine drug release testing and chemical analysis on developmental formulations and candidate reference materials, including applicable USP UV-Vis analyses, Loss on Drying, Karl Fischer titrations, disintegration, hardness, friability, DSC/TGA, laser-diffraction particle-size determination, and liquid chromatography.
Prepare solutions and reagents as needed.
Participate in cross-functional teams involved in reference standards development, including generating and reviewing test protocols.
Research processes and techniques relevant to pharmaceutical dosage-form in vitro testing and dosage-form performance characterization.
Provide and assist with technical and professional training for laboratory staff.
Define critical processes and workflows for projects.
Implement data-collection systems and databases.
Assess protocol effectiveness and develop recommendations for improvement.
Develop and validate analytical methods.
Coordinate team activities and communicate work results.
Assist with the planning, research, and development required for projects.
Prepare and present oral and written reports, including evaluation reports and presentations of data to internal USP audiences and external customers and stakeholders.
Provide project and technical support, including managing project tasks and coordinating with internal and external clients, other departments, and USP customers to establish achievable work schedules.
Mentor laboratory scientists on technical knowledge, work ethics, and attitude.
Initiate and coordinate issue management when necessary using Master Control or equivalent issue-management software.
Serve as technical lead for investigations, corrective-action plans, and implementation of corrective actions.
Troubleshoot method and instrumentation issues, using data mining, trending, and analysis to identify problems or determine process controls needed to mitigate data-quality risks.
Conduct scientific seminars and present scientific work.
Review, interpret, and evaluate available scientific literature.
Investigate, evaluate, and recommend laboratory equipment purchases.