上海招聘

工作职责:

Technical Operation (TO) is a group within PDS, provides technical support for commercial and clinical drug products manufacturing. It is a multi-skilled group comprising expertise from a number of scientific disciplines including; Pharmaceutics, Chemistry, Engineering, and Statistics.

技术部（TO）是制剂事业部下属职能部门，为商业化和临床制剂产品生产提供技术支持。本部门由来自多学科的相关专家组成，包括： 制药，化学，工程和统计学等。

TO provides technical support and leadership in the following areas:

TO部门在以下领域提供技术支持和领导：

1. New Product Introduction & Technology Transfer

新产品引入&技术转移

2. Resolution of product quality issues.

产品质量问题解决。

3. Technical leadership of improvements or changes involving raw materials, packaging/device components, manufacturing processes and analytical procedures.

涉及原材料，包装/设备组件，制造工艺和分析程序的改进或变更的技术领导。

4. Maintenance of product knowledge.

产品知识维护。

5. Definition of manufacturing technology platform strategies and implementation of the technology roadmap for Operations.

定义制造技术平台策略并实施运营技术路线图。

6. Process robustness and technical business processes.

工艺稳健性和技术业务流程。

任职资格:

The role holder will:

该角色将负责：

? Provide immediate technical expertise to aid the resolution of potential product quality incidents.

提供直接的技术专业知识，以帮助解决潜在的产品质量事件。

? Provide technical assessments for proposed product changes, highlight technical risks, and recommend work packages needed to support the change(s).

为拟执行的产品变更提供技术评估，明确技术风险，并为支持变更所需的工作包提供建议。

? Be responsible for technical oversight and governance during the technology transfer of drug products.

负责药品技术转让过程中的技术监督和管理。

? Manage product technical knowledge for their portfolio of products.

管理产品组合的产品技术知识。

? Project manage strategic initiatives within the TO and GO portfolio, including securing sponsorship, resource requirements, stakeholder management, timing and benefits tracking.

管理TO和GO相关项目，包括发起人管理，资源需求，利益相关者管理，时间安排和收益跟踪。

? Act as a business process owner, where necessary.

必要时承担业务流程所有者角色。

? Contribute to the preparation and approval of technically complex responses to regulatory questions ensuring maximum flexibility for Operations.

准备和批准针对法规问题的技术性复杂回复，从而确保运营的***灵活性。

? Actively review the changing regulatory and scientific environment to ensure appropriate actions and activities are proposed and embedded in STA.

积极跟进不断变化的法规和科学环境，以确保提出适当的行动和活动并将其整合到STA体系中。

? Maintain and enhance one’s own technical competence.

维持和增强自己的技术能力。

? Identify opportunities to develop capabilities within Operations sites, and provide training to meet agreed capability targets.

在公司内不断发现进一步提高能力的机会，并提供培训以达到预定能力目标。

? Ensure effective collaboration within R&D and across GMP Operation, including Production, Engineering, Planning and Logistics.

确保与研发以及整个GMP运营（包括生产，工程，计划和物流）之间的有效协作。

? Build effective professional and skill-based networks across PDS.

在整个PDS中建立有效的基于专业和技能的网络。

合全（sta）是药明康德全资子公司，其中包括：上海合全药物研发有限公司( 原药明康德工艺研发部，上海外高桥)，合全药物公司是sta 专门从事工艺合成路线研发及放大实验的研发团队；合全药业金山公司和常州公司是sta 提供符合cgmp 标准的中式放大及商业化生产的基地。
shanghai syntheall pharmaceutical co., ltd. is a wholly-owned subsidiaries of wuxi app tec, including:
sta r&d is professional in route selection and process scaled up r&d;sta jinshan and changzhou are the pilot plants and commercial production base under cgmp.

sta 公司愿景 sta vision：
改变创新药api 的工艺研发和生产模式，加快新药研发速度，降低新药成本，造福人类健康。
transform how industry develops and manufactures apis, shorten the time and lower the cost of new drug developments, improve the quality of life.

sta 公司使命 sta mission：
不断创新、不断完善创新药api 的工艺研发以及研发和商业化生产的一体化平台，为全球新药研发机构提供最优质***效的api 工艺研发和生产一体化服务和***解决方案。
constantly enhance the capabilities of our fully-integrated api development and manufacturing platform from preclinical batches to commercial supplies, provide highly efficient and cost-effective solutions to our partners worldwide.