Senior Scientist I

USP • Rockville, MD

10d

About The Position

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment Brief Job Overview This is a hands-on, non-supervisory position in USP’s Reference Standards Laboratory (RSL). In this role, the Senior Scientist I conducts reviews of routine and non-routine analyses of raw materials, by appropriate analytical methods. The Senior Scientist I works on complex technical problems in analytical chemistry that directly support the development of reference standards, the evaluation, development of official methods, the evaluation of packaging materials, stability studies, product investigations, troubleshooting of equipment, and other general research in analytical chemistry. The Senior Scientist I serves as a technical resource for a variety of analytical techniques for RSL staff and staff from other departments. The Senior Scientist I may execute up to 5% of their work at the bench level. In addition, this position will include project management, technical leadership, and training of RSL employees. The incumbent in this role will utilize their technical expertise, knowledge of current regulatory guidelines, strong organizational and communication skills to ensure high-quality, efficient technical oversight and resolution of technical problems. They will issue high quality reports, serve as a point of contact with stakeholders outside to RSL to resolve issues, and perform reviews of colleagues’ data and reports. How will YOU create impact here at USP? As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

Requirements

• 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.

Nice To Haves

• Experience interpreting and reporting NMR data
• Experience in reference standards analysis, including method development and validation.
• Proficient with testing involving compendial methods for raw materials (USP, BP, EP, etc.) and various dosage forms.
• Expert in HPLC and GC method development and troubleshooting, proficient in other related analytical instrumentation (ICP, KF, UV), hands-on knowledge of LC/MS or GC/MS preferred.
• Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
• Record of leading projects to ensure work is delivered on time and is the highest possible quality.
• Skill to lead projects and build technical expertise in RSL staff by serving as a role model and mentor.
• Ability to conduct research projects independently and to anticipate, troubleshoot, and solve complex technical problems.
• Experience and proven track record of introducing new or innovative technologies to the laboratory.

Responsibilities

• Serves in the role of Project Leader / Reviewer and reviews analytical data and/or generates laboratory reports.
• Provides project and technical support within RSL, including managing project tasks via interacting with clients on activities related to the evaluation of candidate reference materials and collaborating with RSL leaders, other departments, and/or customers to create an achievable work schedule.
• Organizes, implements, and evaluates collaborative studies.
• Conducts analyst training.
• Reviews, interprets, and evaluates scientific literature.
• Serves as a mentor for scientists in the laboratory regarding technical knowledge, work ethic, and professional conduct.
• Represents RSL in internal customer meetings to receive/deliver information, requests, and requirements.
• Takes the lead in working with other departments to solve both technical and process-related issues.
• Prepares study reports and presents data internally within USP and externally to customers; serves as the technical lead for deviation investigation, out-of-specification or aberrant results and process changes; troubleshoots assay and instrumentation issues. This involves data mining, trending and analysis to identify problems or determine process control.
• Ability to lead projects to completion with a high degree of scientific expertise.
• Excellent communication and presentation skills, both verbal and written.

Benefits

• USP provides the benefits to protect yourself and your family today and tomorrow.
• From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree