The U.S. Pharmacopeial Convention (USP) Scientist IV, CDL, China Lab in Shanghai, China
Scientist IV, CDL, China Lab
Summary of the Position:
This is a hands-on and highly technical position which requires profound understanding of principles and practice of pharmaceutical analysis. The incumbent works independently or in a team to solve problems that are directly in support of revisions to the USP-NF. These include the evaluation of current compendial methods for Active Pharmaceutical Ingredients (API), excipients, and Drug Products (DP), development and validation of new or replacement compendial methods, and general research for USP to represent current pharmaceutical analytical technology. The incumbent also participates in the collaboration between CDL and other global and local functions to implement the strategy aligned with USP up-to-date goal.
Roles and Responsibilities:
Carry out literature search and prepare project kick-off proposals for new or replacement compendial methods independently;
Take the initiative to abide by project timeline;
Conduct method development and validation and complete all reports within the timeline
Coach junior team members to complete all method development and validation work on time;
Present project milestone progress;
Contribute actively to the scientific discussion and offer constructive criticism;
Write protocols, reports and other relevant documents and ensure the quality of all lab work;
Monitor and maintain a safe working environment including lab and office area;
Maintain a close relationship with manufacturers and vendors for sample procurement and standard-setting support;
Promote the USP brand and impact by close interaction with industry and other regulatory agencies;
Identify the training needs and prepare technical modules to ensure team productivity and quality requirements;
Keep abreast of the latest analytical technology in industry and regulation requirements;
Work with other functions to identify the sustainable business opportunities for CDL and make plans for implementation.
- Ph.D. in relevant chemistry area with at least 3 years relevant lab experiences, MS with at least 7 years relevant laboratory experience, BA/BS science degree with at least 9 years relevant laboratory experience.
- Must have hands-on experience of analytical method development and validation in drug substance (API)/excipients/drug products (DP) and/or specialty chemicals.
Knowledge, Skills and Abilities:
Must be able to work in a fast-paced environment and respond to shifting priorities quickly
Ability to effectively manage multiple parallel projects
Expertise in analytical method development and validation with HPLC and GC is the prerequisite Extensive experience with LC/MS and GC/MS is essential
Thorough understanding and working knowledge of USP-NF monographs and General Chapters is essential
Proficiency in related analysis such as wet chemistry, spectroscopy, titration, and other physicochemical analysis is necessary
Must be able to multitask
Demonstrate teamwork spirit
Good oral, written, and presentation skills in both Chinese and English
Familiarity with GMP and/or ISO 9001 environment is a plus
Familiarity with ISO/IEC 17025 is a plus
Shanghai, Shanghai, China
Job Category Scientific