The U.S. Pharmacopeial Convention (USP) Scientist I/II/III, RSL, USP China in Shanghai, China
Scientist I/II/III, RSL, USP China
Summary of the Position:
This is a hands-on non-supervisory position responsible for successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS) collaborative testing. The incumbent is responsible for collaborative testing for new, replacement, and continuation RS lots, and generating analytical reports, following compliance requirement according to USP quality management system.
Roles and Responsibilities:
Independently maintain a complex portfolio of RS and ensure their availability through successful scheduling operations, maintaining and generating necessary documents, providing complete and accurate information, addressing quality issues and method technical issues.
Review test protocols, conduct test independently, coordinate testing with labs, review/interpret data from laboratory studies, and compile study summary reports.
Complete pre-set project goal timely with compliance to the 17025 quality system.
Provide correct interpretation of test data. Propose and design experimental studies to obtain necessary, reliable data to resolve technical concerns.
Present technical issues/presentations to departmental staff.
BS or higher degree in Chemistry or relevant field. Experience:
Scientist I: Minimum 1 years of lab related experience for MS, or 2 years for BS;
Scientist II: Minimum 3 years of lab related experience for MS, or 5 years for BS, or 1 year as scientist I;
Scientist III: Minimum 5 years of lab related experience for MS, or 7 years for BS, or 2 years as scientist II;
Knowledge, Skills and Abilities:
Must have demonstrable expertise in analytical chemistry and familiar with instrumentation such as HPLC, GC, IC, AA, ICP, CHN, IR, UV/Vis, MS, TLC, Dissolution, Titration and wet chemistry.
Hands on experience and solid knowledge of general analytical methodologies
Must be output driven and able to work in a well-organized environment and respond to shifting priorities.
Excellent technical writing, understanding and communication skills in English
Must have ISO 17025 or GMP/GLP pharmaceutical analytical lab working experience.
Operates collaboratively and team player in a highly technical environment.
Previous analytical technical training experience is preferred
Familiar with business and scientific computer systems and instrument software applications
With capability to translate or explain data in scientific manor
Previous R&D of API in-process control or drug product development experience is preferred.
Solid knowledge and deep understanding of analytical method development and validation process.
Job Category Laboratories