CMC Manager – Drug Product Expert
Posted on: 25/10/2026
Shanghai East China
Permanent
Pharmaceutical and Healthcare
1. Oversee and technically govern external CDMO/partner drug product 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 drug product technical owner for assigned programs, ensuring robust fill/finish process development, transfer, and lifecycle management from early development through commercial stage.
3. Act as a key technical interface between drug product 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 drug product technology topic (platform/process/standard), including governance, technical rationale, implementation roadmap, and change management.
5. Establish and maintain an external drug product 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 drug product/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 drug product processes.
• Strong understanding and hands-on experience in sterile fill/finish process, 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 drug product 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., wholistic particle control strategy) across functions and manufacturing sites to develop one globally aligned technical strategy.
• 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
工作经验
• Relevant experience in pharmaceutical or biotechnology
• MS: 5+ years
• PhD: 3+ 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 drug product technical owner for assigned programs, ensuring robust fill/finish process development, transfer, and lifecycle management from early development through commercial stage.
3. Act as a key technical interface between drug product 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 drug product technology topic (platform/process/standard), including governance, technical rationale, implementation roadmap, and change management.
5. Establish and maintain an external drug product 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 drug product/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 drug product processes.
• Strong understanding and hands-on experience in sterile fill/finish process, 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 drug product 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., wholistic particle control strategy) across functions and manufacturing sites to develop one globally aligned technical strategy.
• 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
工作经验
• Relevant experience in pharmaceutical or biotechnology
• MS: 5+ years
• PhD: 3+ 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.