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 under the supervision of senior staff 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.
ROLES AND RESPONSIBILITIES:
- Carry out literature search and prepare project proposals for replacement or new compendium methods with the help from senior scientists;
- Conduct method development and validation and complete all reports under the supervision of senior scientists;
- Be actively involved in scientific discussion and demonstrates a strong desire to continue learning and grow personal capability;
- With the help from other staff 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
Required Experience
EDUCATION:
SCIENTIST I: Master’s Degree in Chemistry, Analytical chemistry, Pharmacy or related field at least 1 year of relevant laboratory experience, bachelor's degree requires at least 3 years of relevant laboratory experience.
SCIENTIST II: Master’s Degree in Chemistry, Analytical chemistry, pharmacy or related field at least 3 years of relevant laboratory experience, bachelor's degree requires at least 5 years of 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
KNOWLEDGE, SKILLS AND ABILITIES:
- Must be able to work in a fast-paced environment and respond to shifting priorities quickly
- Expertise in analytical method development and validation with HPLC and GC is the prerequisite
- 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