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1. Manage analytical and quality control work at CDMOs and CROs;

2. Provide input into the analytical control strategy for clinical stage programs;

3. Review and approve documentation such as development and qualification reports;

4. Independently lead and develop new experiments, technological or scientific processes;

5. Design and execute compatibility studies, method development and characterization assays to support CMC activities;

6. Proactively share skills/knowledge with others to broaden company capabilities;

7. Take a leadership role within the lab and the group;

8. Independently prepare SOPs and reports, author regulatory documents.

1. B.S. with 7 or more years, M.S. with 5 or more years, or PhD in protein biochemistry, analytical development, formulation development or related fields;

2. Hands-on experience with 2 or more of the following techniques required: LC-MS, H/UPLC, SEC-MALS, icIEF, CE-SDS, SPR, Octet or ELISA techniques;

3. Experience with biotherapeutic drug development including method development, transfer and qualification strongly preferred;

4. Experience with formulation development is a plus;

5. Experience with compatibility studies is a plus;

6. Excellent bench skills and strong documentation skills required;

7. Strong attention to detail and generating quality data required; 

8. Team player with good communication skills and ability to work cross functionally required.

1. 熟悉常用的理化檢測方法，包括但不限于HPLC、UPLC以及CE等儀器設備，用于檢測質粒、核酸的超螺旋比例；具有這些分析方法的開發，轉移，預驗證的工作經驗；