Job Description

工作职责

位置：苏州、广州、连云港

一、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。

二、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：

1. 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。
2. 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。
3. 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。

三、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：

1. 为塌陷温度窗口狭窄的挑战性分子设计和优化冻干周期。
2. 开发快速冻干周期建立的平台方法。
3. 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。

四、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：

1. 通过辅料优化和创新制剂策略解决高粘度挑战。
2. 解决高蛋白质浓度相关的稳定性挑战。
3. 优化制剂以适配自动注射器及其他给药装置。

五、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（成员含科学家与工程师）。

六、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。

七、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。

八、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。

任职资格

一、教育背景（Educational Background）

1. 药剂学、制药科学、生物化学、化学工程或相关专业博士学位。
2. 具有海外知名院校留学背景者优先。

二、相关经验（Relevant Experience）

1. 15 年以上生物药制剂开发直接工作经验，其中至少 8 年担任领导岗位，管理科学家与工程师团队。
2. 必须具备丰富的复杂分子实操经验，包括抗体药物偶联物（ADCs）、双特异性抗体及融合蛋白。
3. 拥有生物药冻干产品及高浓度制剂开发与商业化的经证实业绩记录。
4. 具备复杂生物药全球监管申报（美国 FDA、欧洲 EMA）经验。

能力要求

1. 深厚技术储备 ，包括：

• 复杂分子的冻干周期开发与放大
• 高浓度制剂开发及粘度降低策略
• 抗体药物偶联物（ADC）制剂开发及偶联稳定性优化
• 复杂制剂的原包装及给药装置兼容性研究

1. 在先进制剂技术领域有丰富发表成果及专利记录者优先。
2. 具备搭建并领导高效技术团队的经验。
3. 具备出色的战略规划及跨职能协作能力。

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:

1. ADC Drug Product Development : Overcoming challenges related to payload solubility, surfactant optimization, and conjugation stability.
2. Multi-Domain Molecules : Developing strategies to address aggregation, fragmentation, and viscosity issues in bispecifics and fusion proteins.
3. 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:

1. Design and optimize lyophilization cycles for challenging molecules with narrow collapse margins.
2. Develop platform approaches for rapid lyophilization cycle development.
3. 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:

1. Develop strategies to mitigate high viscosity challenges through excipient optimization and innovative formulation approaches.
2. Address stability challenges associated with high protein concentrations.
3. 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

1. Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field.
2. Candidates with study experience at well-known overseas universities/institutions are preferred.

2. Relevant Experience

1. Minimum of 15+ years of direct experience in biologics drug product development, with at least 8+ years in leadership roles managing scientists and engineers.
2. Extensive hands-on experience with complex molecules including ADCs, bispecific antibodies, and fusion proteins is mandatory.
3. Proven track record in developing and commercializing lyophilized products and high-concentration formulations for biologics.
4. Experience with global regulatory submissions (US FDA, EMA) for complex biologics is essential.

Competency Requirements

1. 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

1. Strong publication and patent record in advanced drug product technologies is highly desirable.
2. Demonstrated success in building and leading high-performing technical teams.
3. Excellent strategic planning and cross-functional collaboration skills.

Job Tags

Similar Jobs