Senior CMC Manager/Associate CMC Director – Upstre
发布于： 25/10/2026
Shanghai East China
Permanent
生命科学、医疗保健、制药
1. Oversee and technically govern external CDMO/partner upstream activities, including scope definition, technical due diligence, development/manufacturing readiness assessments, review/approval of protocols and reports, batch record/release package technical review (as applicable), deviation/investigation support, change control impact assessment, and ensuring on-time delivery with agreed quality standards.
2. Serve as the primary upstream technical owner for assigned programs, ensuring robust cell culture process development, transfer, and lifecycle management from early development through commercial stage.
3. Act as a key technical interface between upstream process development, MST, manufacturing, quality, regulatory CMC, and external partners/CDMOs as needed.
4. Establish and drive a cross-department, cross-site unified technical strategy for a defined upstream technology topic (platform/process/standard), including governance, technical rationale, implementation roadmap, and change management.
5. Establish and maintain an external upstream subject-matter expert (SME) advisor network to support fact-based consultation on controversial or disputed technical topics, enabling rapid risk assessment, option generation, and alignment on scientifically justified decisions.
6. Support global post-approval lifecycle management: continuous improvement, change impact assessment, comparability support, and sustained process verification inputs.
7. Potential CMC Lead responsibility (based on capability and organization need): coordinate end-to-end CMC execution for assigned programs, integrating upstream/downstream/analytical/drug product/supply and driving overall CMC strategy and decision making.
8. Complete any other assignments as determined by supervisor.
Education/ Professional Qualification
MS, or PhD in Biology, Biologics Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific discipline
Technical/Skills Required
• Deep technical expertise in cell culture / upstream processes.
• Strong understanding and hands-on experience in scale-up/scale-down (e.g., bench to pilot to commercial), including engineering principles.
• Solid experience with process development and characterization, identification of CQAs/CPPs, and establishment of process control strategy.
• Proven capability in tech transfer to internal manufacturing and/or CDMO sites: transfer packages, readiness, on-site support, issue triage, and sustained process performance monitoring.
• Strong knowledge of cGMP expectations for upstream operations: deviation/OOS investigation support, CAPA, change control, contamination control mindset, and data integrity.
• Late-stage / commercialization experience preferred, including PC & PPQ readiness, process validation strategy inputs, comparability assessments, and post-approval changes.
• Demonstrated ability to lead a technical topic/center-of-excellence initiative (e.g., bioreactor equivalence strategy) across functions and manufacturing sites to develop one globally aligned technical strategy.
• Knowledge of cell line development, cell banking and releasing testing requirements in different countries is a plus.
• Excellent interpersonal communication skills; able to mediate, influence, and drive decisions in complex cross-functional settings.
• Structured problem solving, risk management, and milestone tracking.
• Demonstrated adaptability to changing work environments and ability to manage dynamic demands effectively.
• High ethics, integrity, and alignment with organizational values.
Working Experience
• Relevant experience in pharmaceutical or biotechnology
• MS: 8+ years
• PhD: 5+ years
Language, Computer Literacy, Office Software, etc.
• Fluency in Chinese and business English languages.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Project.
2. Serve as the primary upstream technical owner for assigned programs, ensuring robust cell culture process development, transfer, and lifecycle management from early development through commercial stage.
3. Act as a key technical interface between upstream process development, MST, manufacturing, quality, regulatory CMC, and external partners/CDMOs as needed.
4. Establish and drive a cross-department, cross-site unified technical strategy for a defined upstream technology topic (platform/process/standard), including governance, technical rationale, implementation roadmap, and change management.
5. Establish and maintain an external upstream subject-matter expert (SME) advisor network to support fact-based consultation on controversial or disputed technical topics, enabling rapid risk assessment, option generation, and alignment on scientifically justified decisions.
6. Support global post-approval lifecycle management: continuous improvement, change impact assessment, comparability support, and sustained process verification inputs.
7. Potential CMC Lead responsibility (based on capability and organization need): coordinate end-to-end CMC execution for assigned programs, integrating upstream/downstream/analytical/drug product/supply and driving overall CMC strategy and decision making.
8. Complete any other assignments as determined by supervisor.
Education/ Professional Qualification
MS, or PhD in Biology, Biologics Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific discipline
Technical/Skills Required
• Deep technical expertise in cell culture / upstream processes.
• Strong understanding and hands-on experience in scale-up/scale-down (e.g., bench to pilot to commercial), including engineering principles.
• Solid experience with process development and characterization, identification of CQAs/CPPs, and establishment of process control strategy.
• Proven capability in tech transfer to internal manufacturing and/or CDMO sites: transfer packages, readiness, on-site support, issue triage, and sustained process performance monitoring.
• Strong knowledge of cGMP expectations for upstream operations: deviation/OOS investigation support, CAPA, change control, contamination control mindset, and data integrity.
• Late-stage / commercialization experience preferred, including PC & PPQ readiness, process validation strategy inputs, comparability assessments, and post-approval changes.
• Demonstrated ability to lead a technical topic/center-of-excellence initiative (e.g., bioreactor equivalence strategy) across functions and manufacturing sites to develop one globally aligned technical strategy.
• Knowledge of cell line development, cell banking and releasing testing requirements in different countries is a plus.
• Excellent interpersonal communication skills; able to mediate, influence, and drive decisions in complex cross-functional settings.
• Structured problem solving, risk management, and milestone tracking.
• Demonstrated adaptability to changing work environments and ability to manage dynamic demands effectively.
• High ethics, integrity, and alignment with organizational values.
Working Experience
• Relevant experience in pharmaceutical or biotechnology
• MS: 8+ years
• PhD: 5+ years
Language, Computer Literacy, Office Software, etc.
• Fluency in Chinese and business English languages.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Project.