Characterization Analysis Direction

Job Responsibilities

1. Lead the development, qualification, and transfer of analytical methods (including HPLC, CE, LC-MS, etc.) during the pharmaceutical product development process.
2. Develop and execute monoclonal antibody characterization schemes for IND and BLA submissions, focusing on structural and degradation pathway characteristics and stability studies to support formulation development.
3. Have a deep understanding of HPLC, LC-MS, CE, DLS, DSC, etc., and be able to independently analyze detection data and handle anomalies.
4. Responsible for the evaluation and application of new detection technologies.
5. Possess cross-departmental communication skills to effectively follow up and communicate project progress.
6. Proactively manage multiple projects effectively with minimal supervision.
7. Be willing to take on various responsibilities with good decision-making abilities.

Qualifications

1. Background in biology, veterinary medicine, biochemical engineering, pharmacy, etc.; bachelor's degree or above.
2. Specialization in analytical chemistry, biochemistry, biophysics, pharmaceutical chemistry, or related fields.
3. Familiarity with cGMP, pharmacopoeia testing, and regulatory requirements for biopharmaceutical submissions and registrations is preferred.
4. Proficient in literature research, excellent English skills, capable of fluent reading and translating English documents.
5. Possess strong professional ethics, teamwork spirit, and communication and coordination skills.

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