U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Scientist III/IV, CDL, China Lab in Shanghai, China

Scientist III/IV, CDL, China Lab

Tracking Code

1395-679

Job Description

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 proposals for replacement or new compendium methods;

  • Conduct method development and validation and complete all reports within the timeline;

  • Present project milestone progress;

  • Be actively involved in scientific discussion and demonstrates a strong desire to continue learning and grow personal capability;

  • 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.

Required Skills

Minimum Requirements

Education:

  • Ph.D. in relevant chemistry area with at least 2 years lab experience, MS with at least 5 years relevant laboratory experience, BA/BS science degree with at least 7 years relevant laboratory experience Experience:

  • Must have hands-on experience of analytical method development and validation in drug substance (API)/excipients/drug products (DP) and/or specialty chemicals

  • Internal promotion: minimum 1.5 years at current scientist level

Required Experience

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

Supervisory Responsibilities:

No

Job Location

Shanghai, China

Position Type

Full-Time/Regular

Job Category Laboratories

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