Characterization Analysis Researcher

Job Responsibilities

1. Lead the development, qualification, and transfer of analytical methods (including HPLC, CE, LC-MS, etc.) during the drug product development process;
2. Develop and implement characterization plans for monoclonal antibodies for IND and BLA submissions, mainly including studies on structural and degradation pathway characteristics and stability to support formulation development;
3. Have in-depth understanding of HPLC, LC-MS, CE, DLS, DSC, etc., and be able to independently analyze various test data and handle anomalies;
4. Responsible for the evaluation and application of new detection technologies;
5. Possess cross-department communication skills to effectively follow up and communicate project progress;
6. Proactive and able to effectively manage multiple projects with minimal supervision;
7. Able to voluntarily assume multiple responsibilities and possess good decision-making skills.

Job Requirements

1. Master's degree or equivalent and above in analysis, biology, pharmacy, or related fields;
2. At least 3 years of relevant work experience; experience in IND or BLA project submissions, protein structure characterization, and formulation development is preferred;
3. Familiarity with cGMP, pharmacopeia, and regulations on biological product submissions and registration is an advantage;
4. Proficient in literature review, excellent in English, capable of fluent reading and translation of English literature;
5. Possess a strong sense of professionalism, team spirit, and communication coordination skills.

HR Email: hr@biotech-pack.com (If interested, please contact us through this email or directly submit your resume)