Hengrui Pharma
CMC lead for Biologics - ??-??????
Hengrui Pharma, Princeton, New Jersey, United States, 08543
??CMC ?????(Strategic CMC Leadership)
????????????????? CMC ??,??????????????(?? FDA??? EMA??? NMPA ?)?????
?????????(End-to-End Program Oversight)
??? CMC ???????????,??:
????????????(Cell Line Development and Upstream Process Development)
????????(Downstream Purification Process Development)
?????????(Analytical Development and Quality Control)
????(???????????)(Drug Product Development (Formulation, Lyophilization, Device Compatibility))
????(Manufacturing Science and Technology)
????(CMC Project Management)
?????????(Project Management Leadership)
???? CMC ??????,???????????????
???? CMC ?????????????????????????
????????(Pipeline Molecule Oversight)
?????????? CMC ???????????
???????(Cross-Functional Integration)
?? CMC ???????,????????????,????????????????????????????
??????(Technical Excellence)
??? CMC ????????,????????(???????????????????)???????????????????
???????(Team Leadership)
??????????? CMC ???????????????????????????????????????????
??????(Risk Management)
????? CMC ??????????????????,?????????
?? 15 ???? CMC ??????????
??????????????????? BLA/MAA ???????????????
?? CMC ?? PM ??????,?????????????
????? CMC ?????????,??:
cGMP ???????
????????,???????(FDA?EMA ?????)??????????
English Job Description (JD)
Job Responsibilities
Location: Suzhou/ Guangzhou/ Lianyungang
Strategic CMC Leadership
Develop and implement comprehensive CMC strategies for the entire biologics portfolio, ensuring alignment with corporate goals and global regulatory requirements (US FDA, EMA, NMPA, etc.). End-to-End Program Oversight
Provide integrated oversight and direction across all CMC functions including: Cell Line Development and Upstream Process Development Downstream Purification Process Development Analytical Development and Quality Control Drug Product Development (Formulation, Lyophilization, Device Compatibility) Manufacturing Science and Technology (Technology Transfer) CMC Project Management Project Management Leadership
Directly manage the CMC Project Management team to ensure effective tracking and reporting of program milestones Implement and maintain robust project management systems and dashboards for real-time program monitoring Ensure cross-functional alignment on timelines, resources, and deliverables across all CMC programs Pipeline Molecule Oversight
Provide comprehensive oversight and guidance for all molecules in the pipeline, from early research through commercialization Establish and maintain molecule-specific CMC development plans and risk mitigation strategies Conduct regular portfolio reviews to track progress, identify bottlenecks, and implement corrective actions Cross-Functional Integration
Serve as the single point of accountability for CMC activities, ensuring seamless collaboration between technical functions and effective integration with Research, Clinical Development, Regulatory Affairs, and Quality Assurance. Technical Excellence
Provide expert guidance on complex CMC challenges, particularly for advanced modalities (ADCs, bispecifics, fusion proteins) and difficult-to-express molecules. Drive innovation in process and product development. Team Leadership
Build, mentor, and lead a high-performing team of CMC leaders, project managers, and subject matter experts. Foster a culture of scientific excellence, innovation, and continuous improvement. Risk Management
Identify and mitigate CMC development risks. Implement effective contingency plans to ensure program success. Qualifications Education Background
Advanced degree (Ph.D. preferred) in Biological Sciences, Chemical Engineering, Biochemistry, or related field. Relevant Experience
Minimum of 15+ years of progressive experience in biologics CMC development Proven track record of successfully leading multiple biologics programs from early development through BLA/MAA approval and commercialization. Strong experience in managing project management teams and implementing project management systems in a CMC environment. Language Proficiency
Fluency in English required; proficiency in Mandarin Chinese is highly advantageous. Competency Requirements Professional Technical Competence
Deep technical expertise across multiple CMC disciplines with strong knowledge of: Process development and scale-up for complex molecules Analytical method development and validation Drug product development including lyophilization and device integration cGMP manufacturing and quality systems Regulatory Communication Ability
Extensive experience with global regulatory requirements and successful health authority interactions (FDA, EMA meetings and inspections). Pipeline Management Ability
Excellent portfolio management skills with experience tracking multiple molecules simultaneously. Leadership Influence
Strong leadership presence with demonstrated ability to influence at all levels and drive decision-making in a matrix environment. Problem-Solving Ability
Excellent strategic thinking and problem-solving skills, with ability to navigate complex technical and regulatory challenges. Communication and Collaboration Ability
Outstanding communication and stakeholder management skills.
Develop and implement comprehensive CMC strategies for the entire biologics portfolio, ensuring alignment with corporate goals and global regulatory requirements (US FDA, EMA, NMPA, etc.). End-to-End Program Oversight
Provide integrated oversight and direction across all CMC functions including: Cell Line Development and Upstream Process Development Downstream Purification Process Development Analytical Development and Quality Control Drug Product Development (Formulation, Lyophilization, Device Compatibility) Manufacturing Science and Technology (Technology Transfer) CMC Project Management Project Management Leadership
Directly manage the CMC Project Management team to ensure effective tracking and reporting of program milestones Implement and maintain robust project management systems and dashboards for real-time program monitoring Ensure cross-functional alignment on timelines, resources, and deliverables across all CMC programs Pipeline Molecule Oversight
Provide comprehensive oversight and guidance for all molecules in the pipeline, from early research through commercialization Establish and maintain molecule-specific CMC development plans and risk mitigation strategies Conduct regular portfolio reviews to track progress, identify bottlenecks, and implement corrective actions Cross-Functional Integration
Serve as the single point of accountability for CMC activities, ensuring seamless collaboration between technical functions and effective integration with Research, Clinical Development, Regulatory Affairs, and Quality Assurance. Technical Excellence
Provide expert guidance on complex CMC challenges, particularly for advanced modalities (ADCs, bispecifics, fusion proteins) and difficult-to-express molecules. Drive innovation in process and product development. Team Leadership
Build, mentor, and lead a high-performing team of CMC leaders, project managers, and subject matter experts. Foster a culture of scientific excellence, innovation, and continuous improvement. Risk Management
Identify and mitigate CMC development risks. Implement effective contingency plans to ensure program success. Qualifications Education Background
Advanced degree (Ph.D. preferred) in Biological Sciences, Chemical Engineering, Biochemistry, or related field. Relevant Experience
Minimum of 15+ years of progressive experience in biologics CMC development Proven track record of successfully leading multiple biologics programs from early development through BLA/MAA approval and commercialization. Strong experience in managing project management teams and implementing project management systems in a CMC environment. Language Proficiency
Fluency in English required; proficiency in Mandarin Chinese is highly advantageous. Competency Requirements Professional Technical Competence
Deep technical expertise across multiple CMC disciplines with strong knowledge of: Process development and scale-up for complex molecules Analytical method development and validation Drug product development including lyophilization and device integration cGMP manufacturing and quality systems Regulatory Communication Ability
Extensive experience with global regulatory requirements and successful health authority interactions (FDA, EMA meetings and inspections). Pipeline Management Ability
Excellent portfolio management skills with experience tracking multiple molecules simultaneously. Leadership Influence
Strong leadership presence with demonstrated ability to influence at all levels and drive decision-making in a matrix environment. Problem-Solving Ability
Excellent strategic thinking and problem-solving skills, with ability to navigate complex technical and regulatory challenges. Communication and Collaboration Ability
Outstanding communication and stakeholder management skills.