SD​/AVP pf Biologics Drug Product Development — 恒瑞-全球精英计划

Human Resources Leadership Development Program | Talent Acquisition at Hengrui Pharmaceuticals

Job Responsibilities

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 optimise lyophilization cycles for challenging molecules with narrow collapse margins.
• Implement advanced characterization techniques (e.g., freeze‑dry microscopy, manometric temperature measurement) for cycle optimisation.

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 optimisation and innovative formulation approaches.
• Address stability challenges associated with high protein concentrations.
• Optimize formulations for compatibility with auto‑injectors and other delivery devices.

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

5. 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.

6. Technology Innovation

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

7. CMC Regulatory Strategy

Lead the preparation and defence 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.
• 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 commercialising lyophilised 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:
• Lyophilisation cycle development and scale‑up for complex molecules
• High‑concentration formulation development and viscosity mitigation strategies
• ADC drug product development and conjugation stability optimisation
• 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.