Chief Analytical Scientist

Job Summary

The Chief Analytical Scientist will be responsible for product quality research and analysis in drug development. Through in-depth understanding and analysis of disease control requirements, market demands, and the latest technological developments, you will be responsible for formulating and executing pharmaceutical analysis R&D strategies. You will lead teams in developing and validating analysis methods, ensuring drug quality, and contributing to the writing and review of drug registration materials to advance the new drug development process.

 Roles and Responsibilities

1. Lead and support the development of analytical methods for biopharmaceuticals (including vaccines, antibodies, CGT, etc.), advancing products from preclinical to clinical stages.
2. Guide the team in various chemical-physical or biological functional analyses for sample testing and support biomolecule development.
3. Write, review, and approve SOPs, experimental methods, and reports. Support the design of non-clinical and clinical research protocols, and data analysis.
4. Lead or participate in studies supporting the CMC development of biopharmaceuticals, including CQA assessments, comparability studies, and detailed characterization of biopharmaceuticals’ properties to understand products and processes. Assist with the preparation of source documents, including regulatory submissions, and facilitate the submission of various regulatory CMC documents.
5. Provide guidance and mentorship for the team.

Qualification and Requirements

1. Doctoral degree in pharmacy, chemistry, analytical chemistry, or biochemistry with at least 6 years of biopharmaceutical experience in industry; or an experienced master's degree holder with over 10 years of biopharmaceutical experience in industry.
2. Proficient in analytical testing methods including physicochemical properties, content, purity and impurities, biological activity, and immunological effects. Experienced in the development, optimization, validation, and transfer of analytical methods. Well-versed in process development and comparability studies. Experienced in the full lifecycle management of analytical methods.
3. Capable of independently designing experiments and making informed improvements based on results, with a strong aptitude for scientific thinking and logical judgment. Skilled in problem solving through project experience.
4. Possess systematic domain expertise and strong experimental skills, capable of leading team members to complete major projects.
5. Experienced in experimental design, development, optimization, and problem solving. Knowledgeable of CMC-related regulatory requirements (FDA, EMA, NMPA, ICH).
6. Fluent in English, able to research English academic literature.