MST Senior Purification Manager

Roles/Responsibilities 职责 • Responsible for purification 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 负责临床阶段产品纯化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 • 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 purification area to support manufacturing, including process monitoring, troubleshooting, deviation investigation and change control 提供纯化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 generation and review of CMC sections in IND, IND amendment or BLA submission 支持IND、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 purification process SME as needed 根据需要作为纯化工艺的SME支持国内外审计工作 • Manage MST purification team and lead goal setting, work planning and coordination; Collaborate effectively with internal and external teams to meet site goals 管理MST纯化团队，并带领团队开展目标设定、工作规划和统筹协调；与公司内外团队进行有效合作实现工厂目标 • Lead, mentor and train team members; Provide technical guidance for the team and empower appropriately to help them continuously develop skills and experience 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 • Ensure the department operation and staff is compliance with company EHS policy and procedure, fulfill responsibility of EHS related regulation, timely treat EHS related accident and push the EHS risk within department to be eliminated. 确保本部门运营及员工行为符合公司各项EHS规章制度要求，履行EHS相关法规责任，及时处置EHS相关的事故及推动消除本部门范围内的EHS隐患 Job

工作要求 Education/ Professional Qualification 学历/专业资格 Bachelor or above degree in Biological Engineer, Chemical Engineer, Biochemistry, Biotechnology or related scientific/engineering discipline. 生物工程、化学工程、生物化学、生物技术以及相关科学或工程学科本科及以上学位。 Technical/Skills Required 技术/技能需求 • Fundamental understanding and practical experience in purification technologies, including depth filtration, chromatography, viral filtration, ultrafiltration/diafiltration, etc. 具备纯化技术的理论知识和实践经验，包括深层过滤、层析、除病毒过滤和超滤渗滤等技术。

• Demonstrated capability in leading purification process tech transfer and manufacturing support of the therapeutic monoclonal antibody or recombinant proteins 具备领导单抗或重组蛋白下游工艺技术转移和生产支持的能力 • 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 • 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有效进行的沟通和跨部门合作 Working Experience 工作经验 • BS with 10+ years, MS with 8+ years, or PhD with 3+ years of work experience in the Biopharmaceutical industry 学士学位不少于10年，硕士学位不少于8年或博士学位不少于3年的生物制药行业经验 • Extensive experience in protein purification process development, tech transfer, process validation, pilot-scale operation or commercial-scale technical support (at least 2 of the above area) 有蛋白纯化工艺开发、技术转移、工艺验证、中试操作以及商业化规模生产支持的经验（不少于2项） • Experience in supporting regulatory submission and on-site auditing/inspection 有支持注册申报和现场审计核查经验 • Experience in people management 有人员管理经验 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 • Good Written and Communication Skills in both English and Chinese 良好的中英双语写作和沟通技巧 • 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. 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.