The U.S. Pharmacopeial Convention (USP) Scientist II in Richmond, Virginia
Summary of the Position
This is a non-supervisory, technical position in USP’s Manufacturing Services Department. In this role, the incumbent is responsible for developing analytical methods to support process chemistry development, mainly in continuous operations for active pharmaceutical ingredients (APIs). This work includes carrying out experiments related to development of analytical methods to monitor and characterize continuous flow processes and supporting laboratory metrology activities. The incumbent may execute 70% - 90% of their work at the bench level. They conduct a wide range of protocols and analyses on complex projects as part of the AMT project teams, while providing insights, recommendations, and data-based conclusions. They closely collaborate with other scientists and/or other USP personnel.
Roles and Responsibilities
Work with a group of innovative scientists to support continuous process development activities for APIs, as well as analytical instrument troubleshooting.
Interact closely with external partners of our manufacturing network in identifying, implementing, and troubleshooting test methods and workflows for ensuring compliant, robust API continuous process.
Develop and validate analytical methods through collaboration with external science partners to develop methods for assessing the quality of batch and continuous manufacturing processes.
Provide analytical support to process development groups.
Perform analysis using a variety of analytical methods such as HPLC, GC, spectroscopy, and mass spectrometry.
Manage schedules and execute in-house qualification, calibration, preventative maintenance, and other validation and metrology activities to ensure instruments remain in compliance with ISO standards and SOPs.
Diagnose issues, make repairs, and maintain records for equipment and instruments.
Contact outside service providers for repairs and to assist with troubleshooting issues when appropriate.
Write reports and prepare slides for presentations.
Use existing databases to document project progresses, track and report the status of assignments to management on a regular basis.
Work with cross-functional teams within the organization to solve both technical and process-related issues.
Demonstrate strong technical skill and expertise in specific laboratory methods and troubleshoot instrumentation within area of expertise.
Seek out innovative ways to apply knowledge or skills to improve protocols and results.
Actively engage with overall project and ensure own work is aligned with overarching goals.
Recommend and implement new approaches or processes to improve laboratory operations.
Attend scientific seminars and conferences and make presentations.
Help in establishing quality systems in the laboratory.
Assist in technology transfer activities.
Other duties as assigned.
- M.S. in chemistry or related field with at least 2 years of relevant laboratory experience, or B.A. /B.S. in chemistry or related discipline with at least 4 years of relevant laboratory experience.
Good technical writing and verbal communication skills are required.
Good interpersonal skills and process ability to function in a team-oriented environment are necessary.
Understanding of use and routine maintenance of chromatograph systems and other laboratory instrumentation.
Experience in method development and characterization of compounds.
Experience with a wide variety of software and information systems.
Instrumentation or metrology laboratory experience.
Hands-on experience with a wide range of analytical instrumentation including, but not limited to HPLC, GC, MS, spectroscopy, other analytical instrumentation, and associated software.
Experience with installation, performance maintenance, troubleshooting, support end-user utilization of scientific instrumentation, preference for previous Waters/ Agilent product suite (GC, LC, LC/MS, HPLC/UPLC).
Working knowledge of analytical methods development and/or instrument validation under cGMP environment
Working knowledge of API and/or finished product testing and capacity to collaborate in a cross-functional group.
Strong organization skills with an ability to meet deadlines.
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP offers an impressive benefits package, including:
Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start
An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time