Scientist II, RSL (Stability)

Job Description

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 key hands-on, non-supervisory position. In this role, the Scientist initiates and executes stability studies for reference standards using appropriate compendial methods. Additionally, the incumbent will be responsible for performing analytical method development and validations for Impurity RS and maintaining safety and GLP environment in the lab. The Scientist will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. The scientist has mastered many common techniques in the laboratory and can contribute their own observations and input to difficult projects. The incumbent will provide technical assistance to the Stability 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? 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. Conducts stability testing and records data. Prepares reports, evaluates trends, and develops models. Executes testing with minimal errors. Completes projects on time and responds to QA. Experienced in method development and validation using HPLC and GC. Designs and executes experiments and validations. Prepares protocols and engages in project planning. Improves lab operations and aligns projects with goals. Prepares SOPs, ensures GLP, and calibrates equipment. Solves complex problems with scientific approach. Follows USP standards and prepares for ISO certifications. Supports collaborative testing and other teams. Committed to continuous learning. 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 Education: Master's in M.Sc. (analytical/organic) or M. Pharma (pharmaceutical sciences/analysis). Experience: 3-6 years relevant experience in pharmaceutical analytical laboratory. Skills: Pharmaceutical testing for APIs and Formulations. Chromatographic systems (HPLC, GC) handling and troubleshooting. Expert in Empower software with knowledge on Audit trails and Custom fields. Wet chemical analysis (Titrations, IR, KF, UV, Thermal, Elemental analysis). Stability chambers management and monitoring. Long-term and shipping stability studies per USP internal guidelines and WHO, ICH guidelines. Analytical method development and validation. Lab management systems and electronic laboratory notebooks. Attributes: Excellent communication, highly responsible, adaptable, and capable of leading change. Additional Desired Preferences Having knowledge of Lab Management System (LMS) and Electronic Laboratory Notebook, ERP, QR coding system is an added advantage. Hands-on experience in handling instruments like MS is an added advantage. Understanding monograph procedures and participating in compendial methods for reference materials (USP, FCC, NF, etc.). Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or Analytical R&D, or a contract pharmaceutical analytical laboratory testing organization is a plus. Awareness of ISO/IEC 17025 is desirable. Supervisory Responsibilities No 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. 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 Job Category Chemistry & Scientific Standards Job Type Full-Time Show more Show less