SD / AVP pf Biologics Drug Product Development -??-??????

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

• 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.

• 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.

• 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.
• 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.
• Team Leadership & Development

Build, mentor, and lead a high-performing team of scientists and engineers specializing in complex molecule drug product development.

• 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.

• Technology Innovation

Champion the implementation of cutting-edge technologies including computational modeling, advanced analytics, and continuous manufacturing approaches for drug product development.

• 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

• 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.
• 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.