Hengrui Pharma
SD/AVP pf Biologics Drug Product Development - (Princeton)
Hengrui Pharma, Princeton, New Jersey, United States, 08543
Strategic Leadership
Technical Excellence in Complex Molecules
ADC ADC Drug Product Development Multi-Domain Molecules Novel Modalities Advanced Lyophilization Development
High-Concentration Formulation Expertise >150 mg/mL
Team Leadership & Development
CMC Global CMC Integration
Technology Innovation
CMC CMC Regulatory Strategy
Educational Background
Relevant Experience 15
8 ADCs
FDA EMA
ADC
Job Responsibilities Location: Suzhou/ Guangzhou/ Lianyungang 1. Strategic Leadership Define and implement the overall drug product development strategy with specialized focus on complex molecules (bispecifics, ADCs, fusion proteins), advanced lyophilization platforms, and high-concentration formulation technologies. 2. Technical Excellence in Complex Molecules Provide expert guidance in addressing unique challenges of complex biologics, including:
ADC Drug Product Development : Overcoming challenges related to payload solubility, surfactant optimization, and conjugation stability. Multi-Domain Molecules : Developing strategies to address aggregation, fragmentation, and viscosity issues in bispecifics and fusion proteins. Novel Modalities : Establishing platform approaches for emerging biologic formats while developing molecule-specific solutions. 3. Advanced Lyophilization Development Lead the development of sophisticated lyophilization strategies for complex molecules:
Design and optimize lyophilization cycles for challenging molecules with narrow collapse margins. Develop platform approaches for rapid lyophilization cycle development. Implement advanced characterization techniques (e.g., freeze-dry microscopy, manometric temperature measurement) for cycle optimization. 4. High-Concentration Formulation Expertise Drive the development of high-concentration formulations (>150 mg/mL) for subcutaneous delivery:
Develop strategies to mitigate high viscosity challenges through excipient optimization and innovative formulation approaches. Address stability challenges associated with high protein concentrations. Optimize formulations for compatibility with auto-injectors and other delivery devices. 5. Team Leadership & Development Build, mentor, and lead a high-performing team of scientists and engineers specializing in complex molecule drug product development. 6. Global CMC Integration Serve as the drug product subject matter expert for complex molecules, collaborating with Process Development, Analytical Development, and Regulatory Affairs to define and implement advanced control strategies. 7. Technology Innovation Champion the implementation of cutting-edge technologies including computational modeling, advanced analytics, and continuous manufacturing approaches for drug product development. 8. CMC Regulatory Strategy Lead the preparation and defense of drug product sections in global regulatory submissions, with particular expertise in justifying complex formulation and process decisions to health authorities. Qualifications 1. Educational Background Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field. Candidates with study experience at well-known overseas universities/institutions are preferred. 2. Relevant Experience Minimum of 15+ years of direct experience in biologics drug product development, with at least 8+ years in leadership roles managing scientists and engineers. Extensive hands-on experience with complex molecules including ADCs, bispecific antibodies, and fusion proteins is mandatory. Proven track record in developing and commercializing lyophilized products and high-concentration formulations for biologics. Experience with global regulatory submissions (US FDA, EMA) for complex biologics is essential. Competency Requirements Deep technical expertise
in: Lyophilization cycle development and scale-up for complex molecules High-concentration formulation development and viscosity mitigation strategies ADC drug product development and conjugation stability optimization Primary packaging and delivery system compatibility for complex formulations Strong publication and patent record in advanced drug product technologies is highly desirable. Demonstrated success in building and leading high-performing technical teams. Excellent strategic planning and cross-functional collaboration skills.
Technical Excellence in Complex Molecules
ADC ADC Drug Product Development Multi-Domain Molecules Novel Modalities Advanced Lyophilization Development
High-Concentration Formulation Expertise >150 mg/mL
Team Leadership & Development
CMC Global CMC Integration
Technology Innovation
CMC CMC Regulatory Strategy
Educational Background
Relevant Experience 15
8 ADCs
FDA EMA
ADC
Job Responsibilities Location: Suzhou/ Guangzhou/ Lianyungang 1. Strategic Leadership Define and implement the overall drug product development strategy with specialized focus on complex molecules (bispecifics, ADCs, fusion proteins), advanced lyophilization platforms, and high-concentration formulation technologies. 2. Technical Excellence in Complex Molecules Provide expert guidance in addressing unique challenges of complex biologics, including:
ADC Drug Product Development : Overcoming challenges related to payload solubility, surfactant optimization, and conjugation stability. Multi-Domain Molecules : Developing strategies to address aggregation, fragmentation, and viscosity issues in bispecifics and fusion proteins. Novel Modalities : Establishing platform approaches for emerging biologic formats while developing molecule-specific solutions. 3. Advanced Lyophilization Development Lead the development of sophisticated lyophilization strategies for complex molecules:
Design and optimize lyophilization cycles for challenging molecules with narrow collapse margins. Develop platform approaches for rapid lyophilization cycle development. Implement advanced characterization techniques (e.g., freeze-dry microscopy, manometric temperature measurement) for cycle optimization. 4. High-Concentration Formulation Expertise Drive the development of high-concentration formulations (>150 mg/mL) for subcutaneous delivery:
Develop strategies to mitigate high viscosity challenges through excipient optimization and innovative formulation approaches. Address stability challenges associated with high protein concentrations. Optimize formulations for compatibility with auto-injectors and other delivery devices. 5. Team Leadership & Development Build, mentor, and lead a high-performing team of scientists and engineers specializing in complex molecule drug product development. 6. Global CMC Integration Serve as the drug product subject matter expert for complex molecules, collaborating with Process Development, Analytical Development, and Regulatory Affairs to define and implement advanced control strategies. 7. Technology Innovation Champion the implementation of cutting-edge technologies including computational modeling, advanced analytics, and continuous manufacturing approaches for drug product development. 8. CMC Regulatory Strategy Lead the preparation and defense of drug product sections in global regulatory submissions, with particular expertise in justifying complex formulation and process decisions to health authorities. Qualifications 1. Educational Background Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field. Candidates with study experience at well-known overseas universities/institutions are preferred. 2. Relevant Experience Minimum of 15+ years of direct experience in biologics drug product development, with at least 8+ years in leadership roles managing scientists and engineers. Extensive hands-on experience with complex molecules including ADCs, bispecific antibodies, and fusion proteins is mandatory. Proven track record in developing and commercializing lyophilized products and high-concentration formulations for biologics. Experience with global regulatory submissions (US FDA, EMA) for complex biologics is essential. Competency Requirements Deep technical expertise
in: Lyophilization cycle development and scale-up for complex molecules High-concentration formulation development and viscosity mitigation strategies ADC drug product development and conjugation stability optimization Primary packaging and delivery system compatibility for complex formulations Strong publication and patent record in advanced drug product technologies is highly desirable. Demonstrated success in building and leading high-performing technical teams. Excellent strategic planning and cross-functional collaboration skills.