我们正在寻找一位资深且具备远见卓识的生物药制剂开发负责人,负责搭建并领导我们的全球制剂职能团队。该岗位负责人将负责公司整个生物药管线制剂开发的战略方向制定与端到端执行,重点关注复杂分子、先进冻干技术及高浓度制剂。成功入职者需具备解决下一代生物药独特挑战的深厚专业知识,推动开发出稳定、可生产且以患者为中心的制剂产品,满足全球监管标准(美国 FDA、欧洲 EMA、中国 NMPA)。
We are seeking an accomplished and visionary Head of Biologics Drug Product Development to build and lead our global drug product function. This individual will be responsible for the strategic direction and end-to-end execution of drug product development for our entire biologic pipeline, with particular emphasis on complex molecules, advanced lyophilization technologies, and high-concentration formulations. The successful candidate will possess deep expertise in overcoming the unique challenges associated with next-generation biologics and will drive the development of stable, manufacturable, and patient-centric drug products that meet global regulatory standards (US FDA, EMA, NMPA).
- 战略制定(Strategic Leadership):制定并实施整体制剂开发战略,重点关注复杂分子(双特异性抗体、抗体药物偶联物、融合蛋白)、先进冻干平台及高浓度制剂技术。
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.
复杂分子技术专长(Technical Excellence in Complex Molecules):为解决复杂生物药的独特挑战提供专业指导,包括:
- Provide expert guidance in addressing unique challenges of complex biologics, including:
- ADC 制剂开发(ADC Drug Product Development):解决载荷溶解度、表面活性剂优化及偶联稳定性的技术挑战。
- Overcoming challenges related to payload solubility, surfactant optimization, and conjugation stability.
- 多结构域分子(Multi-Domain Molecules):制定策略以解决双特异性抗体及融合蛋白的聚集、断裂及粘度问题。
- Developing strategies to address aggregation, fragmentation, and viscosity issues in bispecifics and fusion proteins.
- 新型制剂(Novel Modalities):为新兴生物药建立平台方法,同时开发分子特异性解决方案。
Establishing platform approaches for emerging biologic formats while developing molecule-specific solutions.
冻干制剂开发(Advanced Lyophilization Development):主导针对复杂分子的精密冻干策略开发:
- Lead the development of sophisticated lyophilization strategies for complex molecules:
- 塌陷温度窗口狭窄的挑战性分子设计和优化冻干周期。
- Design and optimize lyophilization cycles for challenging molecules with narrow collapse margins.
- 开发快速冻干周期建立的平台方法。
- Develop platform approaches for rapid lyophilization cycle development.
- 采用先进表征技术(如冷冻干燥显微镜、压力温度测量)进行周期优化。
Implement advanced characterization techniques (e.g., freeze-dry microscopy, manometric temperature measurement) for cycle optimization.
高浓度制剂开发(High-Concentration Formulation Expertise):推动用于皮下注射的高浓度制剂(>150 mg/mL)开发:
- Drive the development of high-concentration formulations (>150 mg/mL) for subcutaneous delivery:
- 通过辅料优化和创新制剂策略解决高粘度挑战。
- Develop strategies to mitigate high viscosity challenges through excipient optimization and innovative formulation approaches.
- 解决高蛋白质浓度相关的稳定性挑战。
- Address stability challenges associated with high protein concentrations.
- 优化制剂以适配自动注射器及其他给药装置。
Optimize formulations for compatibility with auto-injectors and other delivery devices.
团队领导与发展(Team Leadership & Development):负责搭建、培养并领导一支专注于复杂分子制剂开发的高效团队。
Build, mentor, and lead a high-performing team of scientists and engineers specializing in complex molecule drug product development.
全球 CMC 统筹(Global CMC Integration):担任复杂分子的制剂领域专家,与工艺开发、分析开发及监管事务团队协作,制定并实施先进控制策略。
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.
技术创新(Technology Innovation):倡导采用尖端技术,包括计算建模、先进分析技术及连续生产方法,应用于制剂开发。
Champion the implementation of cutting-edge technologies including computational modeling, advanced analytics, and continuous manufacturing approaches for drug product development.
CMC 监管战略(CMC Regulatory Strategy):主导全球监管申报中制剂部分的准备与答辩工作,尤其需具备向监管机构论证复杂制剂及工艺决策合理性的专业能力。
- 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.