Function of the Position:
This is a hands-on, non-supervisory position in USP’s R&D Spectrometry Laboratory. In this role, the Scientist II works on technical problems in analytical chemistry that directly support revisions to the USP-NF. These include development or validation of analytical procedures supporting the identity of the drug or drug product. The Scientist II has experience in a broad range of analytical techniques and the ability to conduct experiments independently with essentially no errors. The Scientist II will make advances in science, processes, or internal capability that result in new or improved scientific expertise in the laboratory. The Scientist II may execute 90%-100% of their work at the bench level.
Roles and Responsibilities:
Knowledge, Skills, and Abilities:
- Demonstrates solid scientific approach to analysis in the laboratory;
- Routinely applies personal experience, academic training, and technical insights to solve technical problems;
- Conducts method development and validation of analytical procedures according to USP and international standards;
- Evaluates proposed compendial procedures and reference materials;
- Records experimental data, ensuring clear and accurate transcription of results and calculations;
- Reviews literature for analytical test methods, as well as interprets and evaluates data;
- Energetically participates in standard development teams to execute technical tasks;
- Executes all testing and analysis of data with excellence and essentially no errors;
- Demonstrates a strong desire to continue learning and grow personal capability;
- Contributes at internal and external scientific meetings;
- Pursues, recommends, and implements new approaches or processes to improve laboratory operations;
- Positively influences project direction by ensuring own work is congruent with overall direction of the standard development team;
Working knowledge of spectrometric analyses such as vibrational and electronic spectroscopies, as well as chromatographic and other general analytical chemistry principles. Excellent project organization skills and the capability to plan and conduct own work independently. Possesses the skills to anticipate, troubleshoot, and solve technical problems. Highly motivated individual with excellent technical writing and excellent oral communication skills. Takes personal responsibility to ensure work is delivered on time and is the highest possible quality. Experience working in the pharmaceutical and/or biotechnology industry strongly preferred.
Education and Experience:
Scientist II - M.S. in science and 2 years or a BA/BS and 4 years of relevant laboratory experience.
Scientist III- Ph.D. in science or MS and 5 years or BS and 10 years of relevant laboratory experience.
US Pharmacopeial - 12 months ago