罗氏
Associate Manager - MSAT Technology Transfer MSAT技术转移副经理
Associate Manager - MSAT Technology Transfer MSAT技术转移副经理
发布于 9 小时前基层主管/组长
全职员工仅现场办公工艺工程
工艺工程
Cgmp合规
Msat
工艺优化
技术转移
生物制药
设备验证
跨部门协作
值不值得投
81综合评分
综合评分 81
资深技术管理岗，侧重新厂建设与工艺优化，发展空间广阔，WLB中规中矩
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
6.0万
比工艺工程中位数高
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
约 300 个在招 · 其中工艺工程 3 个
市场机会
选择面较广
上海 · 工艺工程 · 约 210 个在招
职位详情
关于这个职位
负责罗氏上海生物药生产基地的制造科学与技术（MSAT）技术转移工作，核心聚焦视觉检测（VI）与本地包装开发（LPD）
需主导新厂启动、设备验证、工艺优化及跨部门协作，确保生产流程符合cGMP标准并实现高效量产，同时培养技术团队
最低要求
Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above
At least 5 years of experience in visual inspection and/or local packaging development, with a minimum of 8 years MSAT/Technical or operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
Comprehensive knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
Ability to think strategically, translate high-level strategies into actionable plans, and embrace agile methodologies to foster adaptability and effectiveness
Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders
工作职责
Visual inspection (VI) and local packaging development (LPD) Strategy & Execution:
Serve as a technical authority and strategic advisor for visual inspection systems and local packaging development, ensuring the implementation of state-of-the-art processes that align with cGMP/SHE standards and Roche’s quality policies.
Provide comprehensive technical oversight of visual inspection and packaging workflows, integrating innovative approaches for automated and manual inspection systems, defect detection accuracy, ensuring uncompromised product quality and compliance with global standards.
Develop, validate, and standardize packaging processes, including container selection, sealing integrity, and compatibility testing, to deliver robust packaging performance across all product lifecycle stages.
Serve as an expert in the validation and optimization of LPD and VI systems, enabling seamless production readiness and long-term operational excellence within Roche’s global biopharmaceutical manufacturing framework.
Champion the introduction of advanced visual inspection technologies and innovative packaging methodologies, such as real-time quality monitoring systems, automated defect classification, and sustainable packaging materials, to enhance accuracy and operational flexibility.
Technology Transfer & Operations:
Drive the technical transfer of VI systems and packaging processes, ensuring seamless integration of new product introductions (NPI) into commercial production workflows.
Lead efforts to qualify and optimize visual inspection equipment and packaging systems during new facility start-up, including the validation of inspection machines, container closure integrity testing, and packaging material performance under local regulatory conditions.
Facilitate continuous improvement in VI and LPD processes by identifying, evaluating, and implementing advanced technologies to enhance defect detection, packaging operations efficiency, and reduce long-term operational risks.
Define and execute technical transfer strategies aligned with site priorities, global supply chain requirements, and Roche's overarching operational strategy.
Influential Leadership & Global Interaction:
Demonstrates strong creative leadership skills aligned with the Visionary, Architect, Coach, and Catalyst (VACC) model, with a proven ability to cultivate a forward-thinking outlook and effectively eliminate barriers to progress.
Collaborate with cross-functional teams (R&D, QA, Engineering, Supply Chain) to ensure the implementation, optimization, and alignment of visual inspection and local packaging operations.
Acts as a mentor and coach to less experienced colleagues, providing guidance in mastering complex VI&LPD workflows, troubleshooting technical challenges, and developing skills in MSAT operations.
Facilitate robust interaction and collaboration with global team members, internal stakeholders, and external partners to support alignment on VI and LPD strategies, projects, and key milestones.
Engineering Project and Site Start-Up Support:
Participate in the design and construction of new facilities, including but not limited to process design, equipment selection, URS review, FAT, SAT, IOPQ, APS and other aspects related to VI&LPD, thereby contributing to project delivery.
Lead the development, implementation, and maintenance of VI&LPD systems, ensuring integration into overall facility workflows.
Collaborate with MSAT leadership to align process engineering strategies with site and global technical roadmaps, ensuring seamless integration and strategic consistency.
Provide critical expertise, contribute, and deeply involved in the Fit for Future (FFU) program, ensuring successful site start-up of MSAT operations.
Technical Expertise & Innovation:
Lead the design, execution, and optimization of visual inspection systems (automated and manual), ensuring advanced technologies are implemented to achieve accurate defect detection, reliable performance, and regulatory compliance.
Develop and execute robust local packaging development strategies, including container closure integrity (CCI) testing, mechanical durability evaluation, and transportation validation to ensure packaging meets both global and local market requirements.
Develop risk management frameworks (e.g., FMEA and control strategies) for VI&LPD, addressing critical process parameters to ensure defect detection accuracy and packaging performance consistency.
Drive technical innovation by implementing digital and automated solutions to enhance equipment performance, reduce batch discrepancies, and improve overall operational flexibility at the site.
Champion continuous improvement initiatives targeting process robustness, waste reduction, faster cycle times, and optimized equipment performance with a focus on compliance, cost-efficiency, and sustainability.
Technical Transfer & Cross-Functional Collaboration:
Deeply involved in the end-to-end technical transfer from R&D to commercial manufacturing, ensuring alignment of process parameters, system integration, and facility readiness.
Develop, review, and maintain technical documentation while driving knowledge transfer and training initiatives to ensure operational readiness and continuous capability building within cross-functional teams.
Author and review technical documentation related to visual inspection and packaging processes, including validation reports, risk assessments, system configuration documents, and sections of technical transfer dossiers.
Act as the primary technical advisor during global and site-level technology transfers, ensuring compliance with cGMP requirements while addressing risks and challenges encountered during scale-up and commercialization.
Manufacturing Support & Compliance:
Provide real-time technical guidance to production teams on issues related to visual inspection accuracy, packaging design, container sealing effectiveness, and regulatory compliance for routine operations.
Oversee the validation and performance monitoring of visual inspection systems and packaging equipment, ensuring adherence to Roche quality standards and alignment with international regulatory expectations (e.g., FDA, EMA, NMPA).
Conduct root cause analysis and implement corrective and preventive actions (CAPA) for issues related to visual inspection systems and packaging processes, ensuring continuous improvement in quality and operational efficiency.
Lead efforts to improve the reliability and automation of VI and LPD systems, reducing operational risks and enhancing process robustness across.
Leadership:
Possesses strong creative leadership aligned with the VACC model, with a proven ability to foster innovation, shape forward-thinking perspectives, and overcome obstacles.
Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion.
Establish and sustain strong partnerships with site leaders to ensure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
Contribute to a culture of continuous improvement and model lean leadership principles.
Foster a culture of transparency, high performance, empowerment and innovation.
Represent Roche MSAT in external VI&LPD forums, conferences, and working groups to benchmark against industry best practices.
Collaborate with VI&LPD vendors to co-develop solutions aligned with Roche’s strategic priorities (e.g., sustainable packaging innovations).
优先资格
Prior experience in formulation and/or aseptic filling is advantageous
Prior experience in people management is advantageous
Proven expertise in strategic project of Aseptic Filling facility, including design, commissioning & qualification
Hands-on experience in new facility startup readiness and operational ramp-up processes
AI 洞察
优缺点分析
优点
- 依托国际领先制药平台，接触前沿生物药制造技术与新厂从0到1建设机会
- 技术视野开阔，国际化团队氛围浓厚，全球协作资源充足
- 技术转移与合规要求极高，工艺放大过程中的容错率极低
- 适合在生物制药制造领域有深厚积累、抗压能力强且追求技术与管理双轨发展的专业人士
缺点 / 挑战
- 岗位职责兼具技术深度与管理广度，职业天花板较高
- 新厂启动期工作压力较大，需频繁对接全球团队与外部供应商
- 需平衡严格的cGMP标准与生产效率，决策压力显著
角色解读
- 向MSAT总监或生产基地运营负责人发展，承担更大规模的管理职责
- 深耕视觉检测/包装领域成为全球级技术专家(SME)或首席架构师
- 拓展至供应链战略规划或新基地筹建负责人角色
- 负责视觉检测与本地包装工艺的规划、验证与技术转移
- 主导新厂设备选型、调试及投产准备，解决生产中的技术难题
- 建立风险管理框架并优化包装完整性测试与缺陷检测流程
- 指导跨部门协作，培训团队成员并确保符合国际监管标准
- 精通cGMP法规与生物制药制造工艺，熟悉FDA/NMPA要求
- 熟练掌握视觉检测系统与包装开发技术，具备设备验证经验
- 具备强大的项目管理、根因分析及CAPA执行能力
- 优秀的英语沟通与跨文化团队协作能力
申请策略
- 提前了解目标企业VACC领导力模型及新厂筹建背景，面试时展现战略思维与跨文化协作能力
- 突出主导过的技术转移项目、新厂启动经验及具体降本增效成果
- 详细列出掌握的检测设备型号、验证方法及风险管控工具(FMEA/CAPA)
- 量化展示包装完整性测试通过率提升或缺陷检出率优化的数据
- 强化对FDA/NMPA最新包装与检测法规的理解及应对策略
- 提升自动化设备与数字化质量监控系统的实操与数据分析知识
- 补充精益生产(Lean)与敏捷项目管理方法论的实际应用案例
面试指南
- 采用STAR法则结构化回答，重点突出风险评估、根因分析、跨部门协同机制及最终达成的量化指标
- 强调合规底线思维，同时展示通过流程优化或技术手段实现效率提升的闭环逻辑
- 结合行业最佳实践，说明技术选型时的成本、风险与可扩展性权衡过程
- 请分享一次你主导的技术转移案例，如何克服规模化生产的挑战？
- 面对新厂设备调试中的突发质量问题，你的处理流程是什么？
- 如何平衡严格的cGMP合规要求与生产效率？请举例说明
- 你如何评估并引入新的视觉检测或包装技术？
- 复习生物制药包装完整性测试(CCI)原理与视觉检测算法基础
职位点评
薪资福利85
成长发展90
工作生活65
使命价值80
薪资福利
85较高
该岗位为资深技术管理角色，薪酬结构完善且职业稳定性强，能有效满足补偿性动机。
薪资信号未披露（AI估算：4.5千–7.5万/月）
成长发展
90较高
岗位深度参与新厂建设与前沿技术引入，提供清晰的SME成长路径与全球协作机会，极大满足发展性动机。
技术前沿前沿/新兴技术
技术栈MSAT、Visual Inspection、Local Packaging Development、cGMP、Technology Transfer、CAPA、FMEA
业务类型profit_center
工作生活
65中等
岗位涉及新厂建设与日常生产支持，工作节奏受项目节点影响，但整体安排相对规律，生活化动机得到中等程度满足。
工作模式未明确
办公地点科技园/产业园
加班情况未提及（无法判断）
使命价值
80较高
直接参与抗癌/罕见病药物生产保障，契合医疗行业改善人类健康的使命感，意义感动机较强。
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号prevent, stop and cure diseases、ensure everyone has access to healthcare today and for generations to come
创新程度积极采用新技术
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