Senior Transfer Scientist/高级技术转移科学家
主要职责:

1.  Tech transfer from internal or external process development. Develop and translate process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment, etc) to ensure successful tech transfer and manufacturing,

2.  In support of resolving complex process issues and trouble shootings for PPQ run and clinical manufacturing.

3.  In support of process development-related documents for IND or NDA submission.

4.  Collaborate with MSAT, Mfg, QA, and QC to set up manufacturing strategy for engineer run and process performance qualification.  

5.  To achieve some GMP-related files, e.g. risk assessment, master validation plan, comparability study, gap analysis, stability study…. etc.

 




任职要求:

1.  In-depth knowledge of current Good Manufacturing Practices and China/US/EU regulations. CAR-T production or process development experience is a Plus.

2.  Demonstrated experience in process characterization and technology transfer.

3.  Strong communication, technical writing, organizational and interpersonal skills. Demonstrates critical thinking skills in problem-solving and decision-making. And able to work independently as well as in teams. Excellent organization and communication skills in Chinese and English.

4.  Experience with statistics in the areas of statistical process control, modeling, and data management is a plus.

5.  MS. in Biological/Biochemical Science/Bioengineering/ Related Field with Minimally 2+ years of biotech industry experience in process development, manufacturing, and Process Validation.

 




招聘人数:1
联系方式:
hr_recruitment@fosunkitebio.com