MST DP Manager

Roles/Responsibilities 职责 Drug Product Development and manufacturing support. The position will collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to support this key function for the organization. 制剂开发和生产支持。该职位将与内部团队、顾问、开发组织、CMO和供应商合作，以支持组织的这一关键职能。 Review batch production records and written instructions to ensure cGMP compliance and maintain current quality standard. 审核批生产记录和书面说明，确保符合cGMP要求，并保持现有的质量标准。 Lead process deviations, investigations and CAPAs and make recommendations to Quality Assurance. 领导工艺偏差、调查和CAPAs，并对质量保证提出建议。 Lead the process optimization project or provide optimization measures and suggestions to the process 领导工艺优化项目，或对工艺提出优化措施和建议。 Review essential elements of scale-up and technology transfer leading to successful process validation and robust commercialization. 审阅扩大生产规模和技术转移的基本要素，从而实现成功的工艺验证和稳健的商业化。 Gather knowledge as the basis for the manufacturing control strategy, the approach for process

and continuous process improvements. 收集相关知识，作为制造控制策略、过程验证和持续过程改进的方法的基础。 Support generation and review of CMC sections in IND amendment or BLA submission 支持IND补充申请或BLA申报CMC部分资料的撰写和审核 Support local and global audit as DP process SME as needed 根据需要作为制剂工艺的SME支持国内外审计工作 Responsible for DP process tech transfer of clinical products into or out from BG GZ as well as process validation and continued process verification for commercial products manufactured at BG GZ 负责临床阶段产品制剂工艺转入或转出广州百济的技术转移以及商业化产品的工艺验证和持续工艺确认 As a SME in a certain field, responsible for leading and guiding the company to solve problems in the field, and conducting training. 作为某个领域的专家，负责领导、指导解决公司遇到的在该领域的问题，并进行培训。 Knowledge of particle control, sterility assurance, single-use materials E/L study, sterile filtration process validation and other related knowledge, at least proficient in a certain field. 了解制剂工艺过程可见微粒控制，无菌保证，一次性耗材相容性研究，除菌过滤工艺验证等相关知识，至少在某一领域较为精通。 Manage team and Lead, mentor and train team members; Provide technical guidance for the team and empower appropriately to help them continuously develop skills and experience 管理团队，带领、指导和培训团队成员；为团队提供技术指导并进行合理的授权，帮助他们持续提高技能和经验 Any other assignment is determined by the supervisor. 完成上级安排的其他工作。 Job Requirements 工作要求 Education/ Professional Qualification 学历/专业资格 BS, MS, PhD degree in Chemical Engineering, Pharmaceutics, or related field. 化学工程、药学或相关专业本科、硕士或博士学历。 Technical/Skills Required 技术/技能需求

1. 01

   Familiar with the production controls and studies of biological drugs in different clinical stages, familiar with the process and related work of DP technology transfer. 熟悉生物药品在不同临床阶段的生产控制要求和研究内容，熟悉制剂技术转移的流程和相关工作。

2. 02

   Familiar with process validation and its different stages of focus and purpose and have rich practical experience in process validation. 熟悉工艺验证及其不同阶段的侧重点和目的，并具有丰富的工艺验证实践经验。

3. 03

   Familiar with regulations and guidelines of Health Authority (e.g., NMPA, FDA, EMA, TGA), ICH, PDA 熟悉药监机构（如NMPA, FDA, EMA, TGA等）、ICH和PDA的法规和指南

4. 04

   Team Player with excellent interpersonal skills, also can demonstrate good team management skills. 良好的团队合作精神，良好的人际关系和团队管理能力。

5. 05

   Demonstrated effective communication and cross functional collaboration in a project-oriented work environment 在以项目为导向的工作环境中能够进行有效的沟通和跨部门协作 Working Experience 工作经验 • At least 8 years of practical experience in liquid and lyophilized DP for bachelor's degree, at least 6 years of practical experience in liquid and lyophilized DP for master's degree, and at least 1 years of practical experience in liquid and lyophilized DP for PhD. 本科至少需8年以上液体和冻干制剂生产经验，硕士至少需6年以上液体和冻干制剂生产经验，博士至少需1年以上液体和冻干制剂生产经验。

• Experience with related technical support for parenteral drug product formulation and filling. 有非肠道药物产品配方和灌装的相关技术支持的经验。

• Experience with related technical support for secondary packaging process validation、process controls 有制剂包装工艺验证、过程控制的相关技术支持经验 • Familiar with GMP requirements, experience on addressing Deviations, Change control, CAPA, and related issues. 熟知GMP要求，有处理偏差、变更控制、CAPA及相关事件的经验。

• Rich practical experience in process validation and related DP process studies. 具有丰富的工艺验证实践经验。

• Rich experience on participating in China and Oversea GMP inspection as a SME. 有丰富的作为SME参与国内外GMP检查的经验。

• Experience in supporting regulatory submission and on-site auditing/inspection would be preferred 有支持注册申报和现场审计核查经验的候选人会优先考虑 • Experience in people management would be preferred 有过人员管理经验的候选人会优先考虑 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 Good reading & writing in both English and Chinese; Excellent computer skills. Proficient in PPT, Excel, Word, Visio and other office software. 良好的英语读写能力和计算机技能，可熟练使用PPT， Excel, Word, Visio等办公软件。 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.