Job Summary职位概述
We are seeking an experienced and highly motivated Senior Director, CMC Management to lead the full lifecycle of development, execution, and delivery of Chemistry, Manufacturing, and Controls (CMC) strategies for our biologics CDMO operations. This role is critical in driving new business acquisition, ensuring the successful execution of client programs, and achieving high levels of client satisfaction. The successful candidate will play a pivotal role in guiding and facilitating cross-functional teams, ensuring seamless project acquisition, execution, and delivery, while maintaining strict compliance with global regulatory requirements.
我们正在寻找一位经验丰富且工作态度积极的CMC管理高级总监，负责领导公司大分子CDMO服务的全生命周期的CMC管理，包括CMC方针策略的制定、执行和交付。此角色在推动新业务获取、确保客户项目的成功执行以及实现高水平的客户满意度方面至关重要。成功的候选人将负责指导并协调跨职能团队，确保项目获取、执行及交付的无缝衔接，同时严格遵守全球监管要求。

Key Responsibilities主要职责
85 Strategic Leadership 战略领导
89 Develop and implement comprehensive CMC strategies to support the business development team in acquiring new clients, from initial contact to contract execution.
- Partner with the sales team to present the company’s capabilities to prospective clients.
- Facilitate the completion of technical questionnaires and ensure the generation of clear Requests for Proposal (RFP).
- Guide the proposal team in preparing high-quality proposals, and serve as a core member of the contract negotiation team to support contract finalization execution.
89 制定并实施全面的CMC战略，支持业务开发团队从初始接触到合同签署的客户转化工作：
- 与销售团队合作，向潜在客户展示公司的能力；
- 协助客户填写技术问卷，确保生成清晰的提案请求（RFP）；
- 指导提案团队准备高质量的提案，并作为合同谈判团队的核心成员，支持合同的最终谈判和执行。

89 During the full lifecycle of CMC project management, lead and oversea CMC strategies for various project types, including mammalian cell culture, microbial fermentation, drug product fill & finish, and xDC platforms. Serve as a consultant of CMC strategy on engineering service projects as required.

89 在CMC项目管理的完整生命周期中，领导和监督各种项目类型的CMC战略，包括哺乳动物细胞培养、微生物发酵、制剂灌装以及xDC平台。视需要为工程服务类项目提供与CMC策略有关的咨询支持。

89 Act as the primary CMC interface between clients and internal teams, including business development, project management, R&D, MSAT, DS/DP Production, Regulatory, Quality, Supply Chain, Engineering and EHS team. Provide technical and strategic guidance to align their objectives with internal capabilities.
89 作为客户与内部团队之间的主要CMC接口，包括商务拓展、项目管理、研发、MSAT、DS/DP生产、法规事务、质量、供应链、工程和EHS团队。提供技术和战略指导，使客户目标与公司内部能力保持一致。
89 Establish and implement robust risk management and mitigation strategies for CMC-related challenges.
89 建立并实施稳健的风险管理和缓解策略，解决与CMC相关的挑战。

Regulatory and Compliance 法规与合规
89 Ensure that all CMC activities comply with global regulatory requirements (e.g., FDA, EMA, ICH) and support the preparation and review of CMC sections of regulatory submissions.
89 确保所有CMC活动符合全球监管要求（如FDA、EMA、ICH），并支持CMC申报文件的准备和审核工作。

89 Stay abreast of industry trends, regulatory changes, and technological advancements to enhance organizational capabilities.
89 密切关注行业趋势、法规变更以及技术进步，以不断增强组织能力。

Qualifications and Requirements任职资格和要求
85 Education 教育背景
89 Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, or related discipline. A Master’s degree with extensive relevant experience will also be considered.
89 生物化学、分子生物学、化学工程或相关领域的博士学位；具有丰富相关经验的硕士学位也会被考虑。

85 Experience 工作经验
89 Minimum 10 years of experience in CMC management, process development, or biologics manufacturing within a global CDMO or biopharma company.
89 至少10年的CMC管理、工艺开发或大分子制造经验，尤其是在国际大分子CDMO或生物制药公司的经验。
89 Proven track record of leading successful CMC programs, including experience with supporting regulatory submissions and interactions with health authorities.
89 在领导成功的CMC项目方面有成熟的经验，包括支持注册团队进行注册文件的提交以及与卫生监管机构的互动。

85 Technical Expertise技术专长
89 In-depth understanding of biologics development, including cell line development, upstream and downstream processes, formulation, and analytical methods.
89 深入了解生物制剂开发，包括细胞株开发、上游和下游工艺、配方以及分析方法。
89 Strong familiarity with quality systems (GMP, ICH Q-series guidelines) and regulatory requirements for biologics manufacturing.
89 熟悉质量体系（GMP、ICH Q系列指南）和生物制剂制造的监管要求。
89
89 在专业领域中英文熟练。
Proficiency in English and Chinese in area of specialization

85 Soft Skills软技能
89 Excellent leadership, interpersonal, and communication skills to manage internal teams and external stakeholders effectively.
89 出色的领导能力、人际交往能力以及沟通能力，能够高效管理内部团队和外部利益相关者。
89 Strong problem-solving, decision-making, and organizational abilities in a fast-paced, dynamic environment.
89 在快节奏、动态环境中具备优秀的问题解决、决策和组织能力。
89 Accept international and domestic travel
接受国际和国内差旅

Reports To: Corporate SVP
汇报对象集团高级副总裁