Description

Note: This is a Fixed-Term role for a 12 month assignment.

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 an on-site hands-on technical position at USP’s Advanced Manufacturing Technology Lab in Richmond, VA. In this non-supervisory role, the incumbent will plan and carry out activities related to developing chromatography methods and perform analyses to support process chemistry development, including continuous operations for active pharmaceutical ingredients (APIs). The incumbent may execute up to 90% of their work at bench level conducting lab work as part of projects, while providing insights, recommendations, and data-based conclusions. They will closely interact with other scientists and/or other USP personnel as well as with external collaborators.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Chromatography Scientist has the following responsibilities:

Work with a group of innovative scientists to support USP’s project work in the Pharmaceutical continuous process development and advanced manufacturing technology areas. Develop and validate analytical methods in collaboration with external science partners for assessing quality and provide analytical support for route development efforts. Interact closely with external partners while identifying, implementing, and troubleshooting test methods and workflows for ensuring compliant, robust pharmaceutical continuous processes.

• 90% of work is expected to be project work at the bench level using a range of analytical instrumentation such as HPLC and GC including but not limited to:
• Plan, perform, and document analytical analyses and other lab bench work according to SOPs and/or test plans. Demonstrates solid scientific approach in the laboratory.
• Set up, operate, troubleshoot, and maintain chromatography instrumentation and equipment to carry out project work and assist others.
• Share in lab safety and housekeeping responsibilities, including 5S organization of workspace and procurement of supplies needed for project work.
• Works with team members to develop effective testing plans and experimental designs.
• Process and interpret collected data and report results to collaborators.
• Write final reports and prepare slides for presentations.
• Carry out peer-reviews of analytical data and reports.
• Share technical expertise with other lab staff and cross-train on methods.
• Seek out innovative ways to apply knowledge or skills to improve protocols and results.
• 10% of work is expected to be related to project administration tasks, laboratory operations, or technical development activities, including but not limited to:
• Engage actively in project and team meetings and ensure own work to be aligned with overarching goals.
• Use existing databases to document project progresses, track, and report status of assignments to management on a regular basis.
• Follow existing quality system procedures, review and revise SOPs as needed, and recommend process improvements as appropriate.
• Assist lab head in planning, implementing, and evaluating laboratory procedures/systems.
• Work with cross-functional teams within the organization to solve both technical and process-related issues.

Who is USP Looking For?

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:

• Degree in chemistry or related field; 4 years of relevant work experience will be considered in lieu of a degree.
• Minimum of three (3) years of experience in laboratory work using chromatography systems (HPLC, UHPLC, and/or GC) including hands-on experience with troubleshooting and routine maintenance of chromatograph systems.
• Focus on working in safe and clean environment.
• Demonstrated interpersonal skills and ability to function in a team-oriented environment.
• Good technical writing and verbal communication skills.

Additional Desired Preferences

• Experience in method development, method validation, and characterization of compounds.
• Experience using mass spectrometry equipment (LCMS or GCMS).
• Hands-on experience with a range of analytical chemistry instrumentation.
• Hands-on experience with a wide variety of instrumentation software and laboratory information systems.
• Working knowledge of API drug substance testing and/or finished drug product testing.
• Pharmaceutical research, pharmaceutical manufacturing, and/or continuous manufacturing experience.
• Ability to produce high quality results within deadlines with minimal supervision.
• Strong organizational skills and attention to detail.
• Skill to anticipate, troubleshoot and solve technical problems.
• Capacity to collaborate in a cross-functional group and with diverse teams.
• Strong communication and presentation skills, both verbal and written.

Supervisory Responsibilities

None.

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.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

Note: 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 Technical Programs

Job Type Full-Time