DS MSAT工艺技术工程师（物料科学方向）*1

ensures that materials meet process performance, product quality, patient safety, regulatory, and GMP manufacturing

, while supporting new product introduction, technology transfer, process validation, and continued commercial manufacturing.

工作职责 / Key Responsibilities

1. 负责抗体及偶联药物生产相关原辅料、一次性使用系统、过滤器、层析填料、膜包、管路、连接件、包装及其他产品接触材料的技术管理和生命周期支持，建立并维护物料技术要求、关键属性及风险分级。

Responsible for technical management and lifecycle support of raw materials, excipients, single-use systems, filters, chromatography resins, membranes, tubing, connectors, packaging, and other product-contact materials used in antibody and bioconjugation manufacturing. Establish and maintain material technical requirements, critical attributes, and risk classification.

2. 支持新项目引入和技术转移阶段的物料可行性及适用性评估，识别客户物料与厂内现有物料、供应商、规格、等级、包装形式和使用方式之间的差异，评估其对工艺、设备、产品质量、供应连续性和生产执行的影响，并提出风险控制策略。

Support material feasibility and suitability assessments during new product introduction and technology transfer. Identify differences between client materials and site materials in supplier, specification, grade, packaging configuration, and use, assess impacts on process, equipment, product quality, supply continuity, and manufacturing execution, and propose risk controls.

3. 负责或参与物料适用性、可替代性和等同性评估，基于物料组成、关键质量属性、功能性能、工艺用途、供应商信息、历史数据和必要的验证或研究，形成科学、可追溯的技术结论。

Lead or participate in material suitability, substitutability, and equivalency assessments. Develop scientific and traceable technical conclusions based on composition, critical quality attributes, functional performance, process use, supplier information, historical data, and required qualification or studies.

4. 负责或协调物料风险评估及支持性研究，包括但不限于原辅料风险、一次性使用系统和产品接触材料风险、过滤器和膜材相容性、吸附或产品损失风险、微生物及内毒素风险，以及必要的浸出物与可提取物评估，并推动风险控制措施落实。

Lead or coordinate material risk assessments and supporting studies, including raw material and excipient risks, single-use system and product-contact material risks, filter and membrane compatibility, adsorption or product loss risk, microbial and endotoxin risks, and extractables and leachables assessments where applicable. Drive implementation of risk controls.

5. 负责项目相关物料支持性技术文件的编写、审核和维护，包括但不限于物料技术评估、物料风险评估、等同性评估、使用条件和限制、取样或测试策略、支持性研究方案及报告。

Author, review, and maintain project related material technical documents, including, technical assessments, risk assessments, equivalency assessments, conditions and limitations of use, sampling or testing strategies, and supporting study protocols and reports.

6. 支持GMP生产物料准备、物料放行前的技术确认和物料spec的制定，协同供应链、仓储、生产、QA和QC识别物料规格、状态、效期、储存、运输、预处理及使用条件方面的风险，推动关键差距在生产前关闭。

Support technical confirmation for GMP material readiness, release and spec establishment. Collaborate with Supply Chain, Warehouse, Manufacturing, QA, and QC to identify risks related to specification, status, shelf life, storage, transportation, pretreatment, and conditions of use, and drive closure of critical gaps before manufacturing.

7. 负责或参与物料相关偏差、异常、投诉、OOS/OOT、变更和供应商变更的技术调查与影响评估，分析物料对工艺性能、产品质量、验证状态和后续批次的潜在影响，支持根因分析、CAPA制定及有效性跟踪。

Lead or participate in technical investigations and impact assessments for material-related deviations, exceptions, complaints, OOS/OOT events, changes, and supplier changes. Assess potential impact on process performance, product quality, validated state, and subsequent batches, and support root cause analysis, CAPA development, and effectiveness follow-up.

8. 为工程批、临床批、PPQ批及商业化生产提供物料相关现场技术支持，及时处理物料替换、批次差异、使用异常和功能性能问题，协调跨部门决策并推动行动项闭环。

Provide shop-floor technical support for engineering, clinical, PPQ, and commercial manufacturing batches. Address material substitutions, lot-to-lot differences, use-related exceptions, and functional performance issues, coordinate cross-functional decisions, and drive action closure.

9. 支持物料供应商选择、技术沟通、变更评估和持续监测，为供应商质量管理提供物料科学方面的技术输入；必要时参与供应商审计、质量协议技术条款评估及供应风险缓解。

Support supplier selection, technical communication, change assessment, and ongoing monitoring, and provide material science input to supplier quality management. Participate, where needed, in supplier audits, technical review of quality agreement provisions, and supply risk mitigation.

10. 支持工艺验证、持续工艺确认和周期性回顾中的物料相关评估，分析物料批次、供应商或关键属性变化与工艺及产品质量趋势之间的关系，为持续验证状态和生命周期管理提供技术输入。

Support material-related assessments for process validation, continued process verification, and periodic review. Evaluate relationships between material lots, suppliers, or critical attribute changes and process or product quality trends, and provide technical input to continued validated state and lifecycle management.

11. 支持IND/BLA等申报资料中物料、一次性使用系统和产品接触材料相关内容的准备、审核及信息核对，支持客户审计、客户拜访及NMPA、FDA、EMA等官方检查中的物料科学问题答复和科学论证。

Support preparation, review, and verification of regulatory submission content related to materials, single-use systems, and product-contact materials for IND/BLA or other filings. Support scientific rationale and responses to material science questions during client audits, client visits, and NMPA, FDA, EMA, or other regulatory inspections.

12. 参与物料科学平台、SOP、技术标准、模板、风险评估工具、物料数据库和知识库的建立及持续优化，推动物料评价标准化、数据趋势分析、供应风险前置管理和最佳实践复用。

Contribute to development and continuous improvement of material science platforms, SOPs, technical standards, templates, risk assessment tools, material databases, and knowledge bases. Promote standardized material evaluation, data trending, proactive supply risk management, and reuse of best practices.

任职要求 / Qualifications

1. 硕士研究生及以上学历，材料科学、高分子材料、化学、化学工程、生物工程、生物化学、药学、制药工程或其他相关专业。

Master’s degree or above in material science, polymer science, chemistry, chemical engineering, bioengineering, biochemistry, pharmacy, pharmaceutical engineering, or a related discipline.

2. 优先考虑具有3年以上生物制药、制药、医疗器械、一次性使用系统、原辅料、包装材料或相关行业的物料技术、工艺开发、技术转移、供应商技术管理、生产支持或MSAT工作经验的候选人。

3+ years of experience in material technology, process development, technology transfer, supplier technical management, manufacturing support, or MSAT within biopharmaceutical, pharmaceutical, medical device, single-use system, raw material, packaging material, or related industries is preferred.

3. 理解抗体或偶联药物生产工艺和物料在工艺中的功能，熟悉原辅料、一次性使用系统、过滤器、层析填料、膜材或产品接触材料中的一种或多种。

Understanding of antibody or bioconjugation manufacturing processes and material functionality, with knowledge of one or more of the following: raw materials, excipients, single-use systems, filters, chromatography resins, membranes, or product-contact materials.

4. 具备物料适用性、等同性、相容性或风险评估能力，能够基于组成、关键属性、功能性能、使用场景、供应商资料和数据形成科学技术结论。

Ability to perform material suitability, equivalency, compatibility, or risk assessments and develop scientific conclusions based on composition, critical attributes, functional performance, use scenarios, supplier information, and data.

5. 熟悉GMP要求以及偏差、变更、CAPA和供应商变更管理流程；具有浸出物与可提取物、一次性使用系统、滤器相容性、物料老化或效期研究经验者优先。

Knowledge of GMP requirements and deviation, change, CAPA, and supplier change management processes. Experience with extractables and leachables, single-use systems, filter compatibility, material aging, or shelf-life studies is preferred.

6. 具备良好的数据分析、技术写作和问题解决能力，能够识别物料属性与工艺性能及产品质量之间的潜在关联，并形成清晰、可追溯的风险评估和技术报告。

Strong data analysis, technical writing, and problem-solving skills, with the ability to identify potential relationships among material attributes, process performance, and product quality and develop clear, traceable risk assessments and technical reports.

7. 具备良好的项目管理和跨职能协作能力，能够与客户、生产、QA、QC、供应链、仓储、工程和供应商开展有效沟通，推动多方行动按时关闭。

Strong project management and cross-functional collaboration skills, with the ability to work effectively with clients, Manufacturing, QA, QC, Supply Chain, Warehouse, Engineering, and suppliers and drive timely closure of actions.

8. 具备良好的中英文读写及口语沟通能力，能够独立撰写和审核中英文技术文件，并使用英语开展技术沟通。

Strong written and spoken Chinese and English, with the ability to independently author and review bilingual technical documents and communicate technical topics in English.

9. 责任心强，逻辑清晰，具备主动学习、风险意识、科学判断、团队合作和问题解决能力，能够适应生产现场支持及项目关键阶段的工作安排。

Strong ownership, logical thinking, learning agility, risk awareness, scientific judgment, teamwork, and problem-solving capability, with flexibility to support shop-floor activities and critical project phases.