Hengrui Pharma
HR Management Trainee | Talent Acquisition at Hengrui Pharmaceuticals
English Job Description (JD)
Job Responsibilities
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
Manufacturing Science and Technology (Technology Transfer)
CMC Project Management
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
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.
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.
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.
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.
Fluency in English required; proficiency in Mandarin Chinese is highly advantageous.
Competency Requirements
1. 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
2. Regulatory Communication Ability
Extensive experience with global regulatory requirements and successful health authority interactions (FDA, EMA meetings and inspections).
Excellent portfolio management skills with experience tracking multiple molecules simultaneously.
Strong leadership presence with demonstrated ability to influence at all levels and drive decision-making in a matrix environment.
5. Problem-Solving Ability
Excellent strategic thinking and problem-solving skills, with ability to navigate complex technical and regulatory challenges.
6. Communication and Collaboration Ability
Outstanding communication and stakeholder management skills.
Seniority level
Entry level
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Hengrui Pharma by 2x
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Job Responsibilities
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
Manufacturing Science and Technology (Technology Transfer)
CMC Project Management
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
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.
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.
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.
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.
Fluency in English required; proficiency in Mandarin Chinese is highly advantageous.
Competency Requirements
1. 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
2. Regulatory Communication Ability
Extensive experience with global regulatory requirements and successful health authority interactions (FDA, EMA meetings and inspections).
Excellent portfolio management skills with experience tracking multiple molecules simultaneously.
Strong leadership presence with demonstrated ability to influence at all levels and drive decision-making in a matrix environment.
5. Problem-Solving Ability
Excellent strategic thinking and problem-solving skills, with ability to navigate complex technical and regulatory challenges.
6. Communication and Collaboration Ability
Outstanding communication and stakeholder management skills.
Seniority level
Entry level
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Hengrui Pharma by 2x
Get notified about new Researcher jobs in Princeton, NJ.
#J-18808-Ljbffr