Scientist III

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.

About the role

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.

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.

Responsibilities

• 75% 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 — involves 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

Qualifications

• 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

Skills & preferences

• Capability to plan and conduct research independently
• Familiarity with cGMP and/or ISO requirements for testing laboratories
• Research experience in dosage form characterization and in vitro testing
• 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
• Ability to build technical expertise in others by serving as a role model and positive influence on the team
• Experience and a proven track record of introducing new or innovative technologies into the laboratory
• Proven analytical and multi-tasking abilities

Benefits

USP provides 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: percentage 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.