杭州健康药物工厂
Position::Drug Substance Operation
City: Hangzhou
Responsibility:
1. Provide local execution support during CTA lot execution at CROs/CMOs.
2. Lead execution of DS startup/scaleup/clinical lots production in new facility.
3. Author, review, and approve documentation such as batch records, procedures, and validation reports.
4. Collaborate cross-functionally with local and global team to troubleshoot/resolve issues and drive improvement.
5. Manage the DS team through the training, operations, performance etc.
6. Proactive and real-time RFT support of critical operations.
7. Communicate and resolve operational variances.
8. Process monitoring including real time review of process parameters and process data/trend analysis. Communicate process performance across shifts and departments.
9. Implement process enhancements, measure and respond to equipment capability and implement new technologies.
10. Provide input, review, and approval for investigations, commitments, and change controls to ensure changes are value added and processes and equipment are robust.
11. Perform skills training and provide subject matter expertise to training materials.
12. Promote a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.
13. Develop programs and strategies for real time process monitoring and right first time.
14. Provide Audit support as SME.
Qualification:
1. BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.
2. Familiarity and experience with mammalian cell culture, protein purification and/or solution formulation is not essential, but is highly desirable.
3. Previous experience in a GMP manufacturing environment desirable.
4. Previous experience with manufacturing-scale bioreactors/fermentors, centrifuge, column chromatography and/or tangential flow filtration (UF/DF) a plus.
5. Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus.
6. Enterprise Systems familiarity preferred, namely LabWare LIMS, SAP, TrackWise, PDOCS and EAMS.
7. Previous leadership skills a plus.
Position::Drug Product Operation
City: Hangzhou
Responsibility:
1. Provide local execution support during CTA lot execution at CROs/CMOs.
2. Lead execution of DP startup/scaleup/clinical lots production in new facility.
3. Author, review, and approve documentation such as batch records, procedures, and validation reports.
4. Collaborate cross-functionally with local and global team to troubleshoot/resolve issues and drive improvement.
5. Manage the DP team through the training, operations, performance etc.
6. Proactive and real-time RFT support of critical operations.
7. Communicate and resolve operational variances.
8. Process monitoring including real time review of process parameters and process data/trend analysis. Communicate process performance across shifts and departments.
9. Implement process enhancements, measure and respond to equipment capability and implement new technologies.
10. Provide input, review, and approval for investigations, commitments, and change controls to ensure changes are value added and processes and equipment are robust.
11. Perform skills training and provide subject matter expertise to training materials.
12. Promote a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.
13. Develop programs and strategies for real time process monitoring and right first time.
14. Provide Audit support as SME.
15. Provide support to DS operation at startup and when needed.
Qualification:
1. BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.
2. Familiarity and experience with Aseptic operation, isolator, lyphilization and solution formulation.
3. Previous experience in a GMP manufacturing environment desirable.
4. Previous experience with manufacturing-aseptic operation , autoclave, VHP, isolator and filling line, freeze drying and packaging. is highly desirable.
5. Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus.
6. Enterprise Systems familiarity preferred, namely LabWare LIMS, SAP, TrackWise, PDOCS and EAMS.
7. Previous leadership skills a plus.