Scientist III

USP; Rockville (MD); On-site; USD 87,000 - 117,000; Full time

Benefits offered by this job

Healthcare options

Retirement savings plan

Paid time off

Job summary

USP in Rockville, MD is seeking a Scientist III for the Reference Standards Laboratory to perform analytical tests, review data, and prepare summary reports. The role focuses on bench work with potential collaboration across teams.

The incumbent will train lab staff, coordinate project tasks, and present findings to stakeholders while adhering to cGMP/ISO guidelines and pursuing scientific excellence.

Qualifications

• Ph.D. in Chemistry or related field, or
• M.S. in Chemistry or related field with 5 years of experience evaluating drug product performance and quality, or
• B.A./B.S. in Chemistry or related field with 10 years of experience evaluating drug product performance and quality.

Responsibilities

• Perform routine drug release testing and chemical analysis using USP methods.
• Participate in cross-functional teams for reference standards development.
• Develop and validate analytical methods and review data.
• Prepare evaluation reports and present data to stakeholders.
• Mentor lab staff and coordinate project tasks and schedules.
• Troubleshoot methods and instrumentation issues and conduct literature reviews.

Skills

Excellent communication skills

Strong presentation skills

Analytical thinking

Education

Ph.D. in Chemistry or related field

M.S. in Chemistry or related field

B.A./B.S. in Chemistry or related field

Job description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Job Overview

This is a hands-on, non-supervisory position in USP’s Reference Standards Laboratory. The incumbent will provide technical assistance to collaborative testing and the continued suitability for use program by performing analytical tests, reviewing analytical data, and preparing summary reports. The incumbent may execute 90% - 100% of their work at the bench level.

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.

The Scientist III Has The Following Responsibilities

• 75% of time in laboratory duties
• Performs routine drug release testing and chemical analysis on developmental formulation and candidate reference materials; examples of test procedures include USP UV-Vis analyses, Loss on Drying, Karl Fischer titrations, Disintegration, Hardness testing, Friability, Differential scanning calorimetry (DSC)/ Thermogravimetric analysis (TGA), particle size determination by laser diffraction, liquid chromatography; Prepares solutions and reagents as needed.
• Participates in cross-functional teams involved in reference standards development, including test protocol generation and review.
• Conducts research into processes and techniques of relevance to pharmaceutical dosage form in vitro testing and dosage for performance characterization.
• Provides and assists in technical and professional training of lab staff members.
• 25% other laboratory duties
• Define critical processes and workflows of projects.
• Implement data collection systems and databases.
• Assess protocol effectiveness and develop recommendations for improvement.
• Develops and validates analytical methods.
• Coordinates activities among the team members and communicates results of work.
• Assists in planning, research, and development required for all projects.
• Prepares and presents oral and written reports.
• Provides project and technical support including managing project tasks via interacting with internal and external clients, other departments and USP customers to create an achievable work schedule.
• Serves as a mentor for scientists in the laboratory regarding technical knowledge, work ethics, and attitude.
• Initiates and coordinates issue management when necessary, using Master Control, or equivalent issue management software.
• Prepares evaluation reports and presents data internally within USP and externally to customers and stakeholders.
• Serves as the technical lead for investigations, corrective action plans and implementation of corrective actions.
• Troubleshoots methods and instrumentation issues. This will involve data mining, trending and analysis to identify problems or determine process controls necessary to mitigate risks to data quality.
• Conducts scientific seminars and presents scientific work.
• Reviews, interprets, and evaluates available scientific literature.
• Investigates, evaluates, and recommends the purchase of laboratory equipment.

Who is USP Looking For?

Qualifications

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

• Ph.D. in Chemistry or related field, or
• M.S. in Chemistry or related field and 5 years of experience evaluating drug product performance and quality, or
• B.A./B.S. in Chemistry or related field and 10 years of experience evaluating drug product performance and quality.

Additional Desired Preferences

• Must have the capability to plan and conduct research independently.
• Familiarity with the cGMP and/or ISO requirements for testing laboratories is required.
• Research experience in dosage form characterization and in vitro testing is required.
• Previous project management experience.
• Excellent communication and presentation skills, both verbal and written.
• Proficient with drug release and product testing involving compendial methods (USP, BP, EP, etc.).
• Accepts personal responsibility to ensure the work is delivered on time and is of the highest quality.
• Skilled in anticipating, troubleshooting and solving technical problems.
• Possesses ability to build technical expertise in others by serving as a role model and positive influence on the team.
• Possesses experience and a proven track record of introducing new or innovative technologies into the laboratory.
• Proven analytical and multi-tasking abilities.

Supervisory Responsibilities: None, this is an individual contributor role.

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.

Compensation

Base Salary Range: USD $86,860.00 - $117,017.50 annually.

Target Annual Bonus : % Varies based on level of role

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.

Job Category

Chemistry & Scientific Standards

Job Type

Full-Time