MST Senior Manager, Drug Product

Roles/Responsibilities 职责 • Responsible for DP tech transfer, process validation, manufacturing support and continued process improvement and verification for ALL clinical/commercial products (liquid, lyo, PFS, ADC, etc.) manufactured at BG GZ 负责所有在广州生产的临床和商业化产品（水针，冻干，预充针，ADC等等）制剂的技术转移、工艺验证、生产支持以及持续工艺优化和确认 • Responsible for technical support and PIP (as needed) for products owned by BG but manufactured at CMO 负责对百济持有并委托CMO生产的商业化产品进行技术支持和驻场监督（根据需要） • Provide scientific knowledge and expertise in DP area to support manufacturing, including process monitoring, troubleshooting, deviation investigation and change control. 提供制剂领域的科学和专业知识以支持生产，包括工艺监控、问题解决、偏差调查和变更控制 • Support authoring and review of CMC sections in IND or BLA submission 支持IND或BLA注册申报CMC部分资料的撰写和审核 • Support both local and global audits as needed in the areas led by MST DP 根据需要为MST DP团队负责的领域提供海内外审计的支持 • Lead and manage MST DP team to complete goal setting, results delivery, and cross-function collaboration; Provide technical guidance for the team and empower appropriately to help them continuously develop skills and experience 领导和管理MST制剂团队完成目标设定、结果交付和跨部门合作；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 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 or above degree in Biological Engineering, Chemical Engineering, Biochemistry, Pharmaceutical Science, or related scientific/engineering discipline 生物工程、化学工程、生物化学、药物科学以及相关科学或工程学科本科及以上学历 Technical/Skills Required 技术/技能需求 Ÿ In-depth understanding and extensive experience of biologics drug product manufacturing, including typical unit operations but not limited to thawing, formulation, pooling, sterile filtration, filling and stoppering, lyophilization, capping, visual inspection, PFS assembly, labeling and packaging 对生物药制剂生产工艺的典型单元操作有深入的理解和丰富的经验，包含但不限于解冻、配制、合并、除菌过滤、灌装压塞、冻干、轧盖、灯检、预充针组装、贴标和包装 Ÿ Demonstrated capability in leading drug product process tech transfer and manufacturing support of therapeutic monoclonal antibody or recombinant proteins 具备领导单抗或重组蛋白制剂工艺技术转移和生产支持的能力 Ÿ Familiar with regulations and guidelines of Health Authority (e.g., NMPA, FDA, EMA, TGA), ICH, PDA for DP manufacturing and sterility assurance; In particular, familiar with requirement for PUPSIT and visible particle control 熟悉药监机构（如NMPA, FDA, EMA, TGA等）、ICH和PDA对制剂生产和无菌保障的法规和指南；尤其要熟悉PUPSIT以及可见异物控制的管理要求 Ÿ 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 Ÿ BS with 11+ years, MS with 9+ years, or PhD with 4+ years of work experience in the biopharmaceutical industry 学士学位不少于11年，硕士学位不少于9年或博士学位不少于4年的生物制药行业经验 Ÿ Extensive experience in drug product process development, tech transfer, process scale-up, process validation, or commercial-scale technical support (at least 3 of the above areas) 具备制剂工艺开发、技术转移、工艺放大、工艺验证以及商业化规模生产支持的经验（不少于3项） Ÿ Experience in supporting regulatory submission and on-site auditing/inspection 具备支持注册申报和现场审计核查的经验 Ÿ Experience in people management 具备人员管理的经验 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 Ÿ Excellent written and verbal communication skills in both English and Chinese. 优秀的中英双语书面和口头沟通技巧 Ÿ Familiar with software such as Microsoft Office, Microsoft project, etc. 熟悉 Microsoft Office, Microsoft project等办公软件的使用。 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. 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