药明生物(WuXi Biologics

    药明康德关联公司，专注于打造开放式一体化的能力和技术平台，为全球生物制药公司和生物技术公司提供全方位的研发生产服务，帮助任何人、任何公司实现生物药研发的梦想。药明生物致力为全球客户提供专业化的一站式生物制药研发生产服务，加速全球生物药从创新想法到商业化生产的研发进程，降低研发成本，造福病患。

全球最大的生物医药研发CRO企业

药明生物已经完成港股上市，代码:HK.02269，在职员工总数突破2000人

最新战略投资计划：

      2017年 6月 30日，全球最大的生物医药CRO(合同研发组织)企业——药明康德新药开发有限公司与成都科学城正式签约，拟投资100亿元(人民币，下同)在成都科学城建药明康德生命健康产业园，并将其作为中国西部战略发展的首选地，集聚该公司上下游产业。
　　此次签约落户的药明康德生命健康产业园项目规划占地1000亩，将建设生物药、制剂研发及生产基地、万创中心、生物样本库、西部总部、罕见病医院等。
　　其中，生物药、制剂研发及生产基地主要建设生物制品的研发服务外包(CRO)与合同生产(CMO)基地，制剂开发和GMP生产基地；生物样本库主要建设针对肿瘤、遗传病等重大疾病的中国国家级生物样本库以及数据库，为新药创新和健康诊治提供基础支撑。


简历投递方式：

Email ：job@wuxibio.com
标题：姓名-最高学历-部门岗位名称-工作地点
附件：1份 中文个人简历，1份英文个人简历，1份中文以往工作或研究总结，1份英文以往工作或研究总结

（以往工作或研究总结请结合自身条件和岗位任职资格书写）
（内容请尽可能详尽，请勿使用压缩包）

若您对以下岗位感兴趣，欢迎投递（请匹配是否符合具体岗位要求！）
（无特别说明，则限制至少一年以上同内容岗位工作经验）

上海 site

细胞构建部
1. 细胞株构建研究员/高级研究员
岗位职责：
能独立地承担高表达细胞株筛选以及工艺优化等工作，详尽规划实验流程并执行完成整个项目进展。
能独立地对试验中出现的疑难问题进行分析和解决，并懂得如何通过文献搜索来帮助解决问题和优化工艺。
能按照公司的实验记录以及档案管理条例要求，认真按时整理实验记录和数据并提交归档。
能独立地完成技术报告的撰写并参与部门会议汇报实验结果。
能独立地完成英文PPT的撰写并参与对国内外客户的会议汇报实验结果。

任职资格：
硕士学历及以上，细胞生物学等相关专业。
有两到三年细胞株构建工作经验优先，有海外留学或工作经验优先。
英文水平良好，口语流利，能够独立撰写英文报告及PPT并向国外客户汇报结果，能与客户用英文进行交流沟通。
能熟练检索和阅读英文文献。并能积极主动的分析，解决工作中出现的问题，会设计实验完成工艺优化。
动手操作能力强，细心认真进行实验和记录实验现象与数据。
团队协作精神，较强的执行力和责任心。


细胞培养工艺开发部
2. 细胞培养工艺开发研究员/高级研究员
岗位职责：
熟悉细胞培养所有实验操作细节及操作流程，并具备扎实的相关理论基础。
领导细胞培养工艺开发项目，合理制定项目工艺开发的整体计划与方案，具备项目报告、项目阶段性汇报及申报资料的撰写及审核能力。
在项目执行层面上全面把关，处理及解决项目技术难题，并对项目技术转移的整个过程负责。
参与细胞培养工艺开发平台建设的工作。
了解生物制品国内外相关申报要求，在项目开展过程中配合现场核查等相关工作。
负责承担部分实验室的管理工作。

任职资格：
生物化工及生物工程等相关专业。
硕士毕业2年以上、或本科毕业4年以上相关行业工作经验。
具备一定的技术创新能力，能够在项目或平台建设中解决技术难题。
具备较强的项目管理能力，具备同时承担2-4个项目的能力，能够统筹协调项目内外部资源，能够把控项目的关键时间点、整体进度及合同范围及指标，并具备较强项目风险控制能力。
具备较强的沟通协调能力，能够独立实现组内及上下游相关工作组间工作的良好沟通与协调。
具备良好英文沟通表达能力，可独立与国外客户沟通与汇报实验进展等项目相关内容。


下游工艺开发部
3. 蛋白纯化研究员/高级研究员
岗位职责：
按客户需求在规定的时间内完成蛋白分子的纯化制备，并进行相关检测，使产品满足客户要求的数量和质量要求。
及时完成相关的纯化实验记录和产品的制备报告。
负责与细胞培养、QC及项目管理等相关部门沟通协调，定期进行内部或与客户的项目进展汇报。
管理和维护纯化相关设备，并培训和指导新员工，以促进小组和部门的高效运行。

任职资格：
生物制药、生物工程、生物技术、生物化工等相关专业，本科及以上学历，一年以上生物制药行业相关经验。
熟练使用AKTA层析系统进行蛋白纯化，熟悉单克隆抗体、融合蛋白等真核表达的纯化工艺。
熟练使用深层过滤、超滤等工艺用于制备实验室规模的产品。
具有蛋白分子订单制备相关工作经验，熟悉产品内毒素控制细节。
掌握蛋白分子的相关检测技术，如HPLC分析、SDS-PAGE分析、Western Blot。
具有原核或真核表达相关标签蛋白的纯化经验。


分析科学和法规事务部
4. Scientist– Protein Characterization,
    Analytical Sciences
岗位职责：
Carry out development, optimization and troubleshooting of analytical methods (RP-HPLC, HIC, IEX, CE etc) for product release.
Conduct and optimize LC-MS based analysis (Intact mass, peptide mapping, N-glycan analysis) to support process development of protein therapeutics.
Interact and communicate with internal partners and external clients to update analytical results, and document experiments, data collection and analysis with GDP standards.
Participate in instrument maintenance, SOP drafting and comply with IPs and 5S principles.

任职资格：
MS degree in analytical chemistry or other related majors (pharmacy, biochemistry,etc.).
Preferred hands on experiences in high resolution LC-MS (Q-TOF, Orbitrap etc).
Good communication skills (both verbal and written) and interpersonal skills.
Team-worker, being responsible and careful.
Lab experiences in pharmaceuticalor biotech industries are advantageous.


制剂和灌装服务部
5. 蛋白制剂研究员/高级研究员
岗位职责：
参与蛋白注射药物的制剂开发，协助研发平台的建设并定期汇总数据对内外管理层及客户汇报。
协助蛋白大分子注射药物制剂的开发。
负责项目制剂处方筛选，工艺研究和稳定性考察工作。
参与内部及外部研发项目的数据汇总及汇报。
按要求规范研究,做好相关原始记录并最终撰写制剂工艺研究报告和相关申报资料。
参与实验室的运行和维护工作，研究设备的调试,测试及维护。
负责生物大分子药物制剂方面的文献调研。

任职资格：
制药工程、药物制剂或生物技术等相关专业本科及以上学历。
较好的英语水平。
对蛋白研究有基础知识背景为优。
拥有相关的制剂或分析背景。
熟悉蛋白类药物检测分析技术，熟悉或掌握SEC，IEX，SDS-PAGE，IEF，CE和紫外分光光度计等纯度和浓度分析技术，能对分析结果进行处理，整合和解释；了解ELISA，GC，DSC，CD，FT-IR等分析原理和操作。
熟悉cGMP/GLP和ICH规程。
拥有相关管项目和人员理经验及团队精神。


项目管理部
6. 韩语/日语/英语项目管理/高级项目管理
岗位职责：
Develop project plans and timeline for the project while working closely with the project CMC leader.
Identify the critical path activities in the timeline and keep the internal staff and the client informed.
Coordinates the internal resources and leads WuXi's efforts for timely completion of projects by interacting with the client and internal technical staff .
Holds regular meetings with team members and with clients to update progress as appropriate.
Keep clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable means.
Monitor timeline and contract for accuracy and follows up on any discrepancies with clients and/or internal personnel.
Confirm the completion of work by stage with client and ensures invoices are sent to client for processing.
Act as a team leader and provide the training, guidance, feedback and review to the team members as needed.


任职资格：
College degree in science/engineering field with 7 years of industrial working experience, or master degree with at least 5 years of working experience in the pharmaceutical or biotech field.
Some experience in project management preferred.
Good Korean / Japanese / English skills (one of them), both written and oral.
Ability to work independently with limited supervision in a fast-paced environment.
Excellent verbal and written communication skills.
Ability to work as a team member and as a leader.
Good multi-tasking and prioritization skills.


业务拓展部
7. 日/韩销售BD经理（生物制药）
岗位职责：
Develop relationships, and execute agreements organically with current and new accounts based upon the suite of service offering.
Achieve annual sales metrics through the acquisition of new business and projects.
Effectively manage an existing customer base of pharmaceutical, biotechnology and academic institutions. 20-30% travel required, including international travels.
Ensure that all proposal/contract details, client meetings, RFP information is captured, maintained and processed.
Coordinating meetings with clients/internal/external stakeholders/project teams.
Routine activities include attending identified trade shows,updating sales pipeline report, development and execution of key account plans, routine customer visits, maintenance of CRM database, and achieving responsible territory sales plan.


任职资格：
BS/MS/PhD with major in Biological Sciences, Chemical engineering,or equivalent training plus 3 or more years of industrial experience on business development/marketing/sales/project management/consulting or equivalent training and/or experience.
Ability to accomplish the described duties through the use of appropriate computer equipment and software (i.e. Microsoft Word, Excel, PowerPoint, Project and Outlook).
Fast learner with great interpersonal skills.
Ability to work under limited supervision and handle complex and cross cultural problems. Ability to work with multidisciplinary team.
Knowledge of Biologics Discovery/Development/Production is preferred.
Knowledge of China FDA and Korea FDA regulatory policy is preferred.
Fluent in Chinese, English and Korean. Basic level of Japanese is a plus.


生物新药研发服务部
8. IND - Enabling Program Management
岗位职责：
Manage, direct and lead preclinical projects in a team environment; Work with clients to proactively identify the right strategy based on their unique program and help clients to select right studies, smartly coordinate the studies to move forward efficiently.
Monitor closely the progress of the project, coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs. Stay on the top of project with continues scientific and technical support. Proactively identify potential issues and input the constructive suggestions.
Interact with clients, other key functions/business units within WuXi AppTec to facilitate the project development; Communicate directly (visiting host, holding TC and auditing, etc.) with national and international sponsors.
Service as an expert for all TOX-related discipline within TAD; Prepare documents package for IND filing; Search and prepare scientific references for project needs.
Initiate issue-oriented agendas to facilitate effective team meeting discussion and able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items.


任职资格：
PhD or equivalence in biomedical/ pharmaceutical science with at least 5 years experience in pharmaceutical/biotech industry in preclinical development with strong toxicology expertise.
Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration.
Familiar with relevant FDA, ICH, EMA/OECD and CFDA guidelines/regulation with hands-on experience on planning and execution of IND/CTA programs.
Team oriented work ethic and ability to work in cross-functional teams.
Excellent written and oral communication skills.
Regulatory writing experience and PMP certification will be a plus.


9. Senior Scientist /Assistant Director
    – B Cell and NGS
岗位职责：
The candidates will have extensive the oretical knowledge as well as bench level experience in the identification and characterization of mAbusing various techniques, such as library display (e.g. yeast, phage, etc), B-cell cloning and NGS method.
The candidate will be responsible for establishing and executing novel antibody discovery platform for generating antibody leads.
The candidates will have good organizational and documentation skills and the ability to plan and simultaneously execute multiple antibody discovery projects.
Industry experience is strong preferred but not absolutely required for the position.


任职资格：
MS with > 5 years or PhD with > 2 years of relevant experience in therapeutic antibody lead generation through cell-based methods. Expertise in one of the following areas.
B cell repertoire analysis using Next Generation Sequencing and molecular biology for antibody discovery.
Hand on experience on cell culture and B cell cloning techniques for antibody discovery.
Experience in the development of novel antibody discovery platforms.
FACS sorting , single cell RT-PCR or B cell culture.
A strong motivation in pursue science in drug discovery.
Adaptable and productive in a fast-paced environment.
Good communication skills required, including writing notebooks and presentation in English.
Strong team-working spirit and excellent communication and inter-personal skills.
Knowledge in immunology，especially B cell immunology.
Applied knowledge of library construction and library display.
Experience in antibody affinity maturation or humanization.
Proficiency in applications of deep sequencing technologies.


10. Scientist/Senior Scientist of
      Functional Assays
岗位职责：
Research on literature, propose assay strategies, design assay validation plans and perform assay development and screening studies for biochemical and cell based assays.
Analyze, interpret, summarize and compiles data independently. Keep appropriate experimental records and documentation.
Lead various assay development and antibody screening efforts preferably through active bench work.
Function as a project representative to coordinate and perform assays within timeline and quality requirement, be able to communicate effectively both internally or externally. Train and manage junior scientists to fulfill desired duties satisfactorily.
Keep compliance with all company and departmental policies.
Other responsibilities may be added at the company's discretion.

任职资格：
Ph.D. or M.S. Degree in cell biology, biochemistry, molecularbiology or a related discipline.
Experience in cell-based or biochemical assay development.
Experience in antibody discovery and characterization, and background in sign transduction and cancer biology is a strong plus.
Project management and communication skills including English proficiency.
High degree of motivation and team work spirit required.


生物偶联药发展部
11. ADC_药物研发、工艺开发及生产研究员
岗位职责：
通过蛋白、偶联链和偶联分子（包括小分子和高分子）的连接，修饰并改良蛋白质，利用蛋白与其受体的特异性结合，达到治疗效果。ADC是一个很好的例子。本职位研究人员将负责生物偶联药物的设计、合成、工艺优化及生产。 他/她需要：
负责蛋白与小分子化学药/多肽等的偶联试验，负责ADC偶联、纯化和分析，及相应的各方法开发参与偶联工艺开发及放大生产。
对产品进行部分生物学及理化分析检测（HPLC,酶标仪等）。
完成实验记录/技术报告的撰写。
完成生产所需相关文件的撰写。

任职资格：
有机化学、药物化学, 生物化学等相关专业本科及以上学历 (硕士,博士)。
能够用英语就实验/生产相关内容与客户进行有效的邮件沟通。
较强的学习能力和分析能力。
强烈的责任心及团队协作精神。
能够适应加班/出差等弹性工作安排。


工艺工程与验证部
12. Group Leader/Associate Director II
      – Validation
岗位职责：
Lead the functions, including but not limit to the activities of C&Q, validation, in R&D and Commercial Facility.
Support the validation function of all existing and future sites in WuXi Biologics.
Support PEV Senior Director with the development of the new biotech manufacturing facilities.
Support engineering related audit/visit by clients and regulatory authorities.
Ensures that the commissioning and qualification of the Commercial Manufacturing Facility comply with appropriate regulatory requirement and construction code.
Serve as an SME of Cleaning Validation, Process Characterization and Process Validation and provide strategic guidance.
Automation and CSV for WuXi Biologics in general and the Wuxi Bio MFG2 facility inparticular.
Establishing ERES and CSV/computerized system ERES compliance part of QMS (QM part, QSGs,SOPs and CSV validation/compliance documents).
Working closely with QC, MFG/FFF, ENG, Operation and IT to achieve and maintain Computerized Systems and ERES compliance.
Lead and act as the key contact person / SME for all issues related to Computerized Systems and ERES compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client communication.
Determine and establish validation requirements for computerized systems based on SOPs and regulatory standards (FDA, EMA) to ensure compliance and maintain an inspection ready state.
Lead the development of system specific validation plans and strategy using a risk-based approach.
Provide (modular) training of validation engineers and/or consultants to effectively produce validation deliverables following CSV SOPs and FDA 21CFR Part11 requirements.
Provide regular updates related to key accountabilities and scope of the job to senior management.
Ensure quality of CSV deliverables for regulated systems and quality of non-regulated systems.

任职资格：
M.S. in chemical engineering and biological engineering discipline with minimum 15 years of hands-on and management in validation and engineering in pharmaceutical and biopharmaceutical industry. At least 10 years in validation management.; PhD degree in the same discipline with minimum of 10 years of related experience.
An expert in related regulatory requirements and industry standards, such as 21CFR Part 11/210/211, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10; ISPE Baseline Guides, and PDA TRs in Cleaning and Process.
Proficient in: SAP, LIMS, MES, Empower, automation, and other pharmaceutical IT systems; Data Management Systems.
Strong collaboration, communication and influence skills.
Good knowledge and experience in GMP, Quality System, EHS.
Fluent in written and verbal English communication.


13. Associate Director II
      – Processing Engineering
岗位职责：
Manage all aspects of process engineering function during the design, build, and C&Q phases of new Commercial Facility. The scope will include, but not limited to, basic design, detail design, and design/build of upstream and downstream process, and stainless steel media/buffer preparation and hold systems in the biotech manufacturing facility.
Lead the turn-over and training of the facility.
Lead the validation function at new site, Wuxi Biologics.
Assist site head and department head to oversee the design, construction,commissioning, qualification, and future operation and management of GMP biotech manufacturing facilities.
Manage engineering firm, GC, equipment vendor and consultant to deliver the site project.
Lead validation function to support the design, construction, commissioning, qualification and operation of all GMP facilities of WuXi Biologics.
Lead the management of Commercial Facility process engineering operations.
Establish and maintain cGMP facility management system.
Manage future GMP facility operation to support cGMP production.
Support engineering related audit/visit by clients and regulatory authorities.
Ensures that the design, construction, commissioning and qualification of the Commercial Facility comply with appropriate regulatory requirement and construction code.
Ensures the upper management is well informed on progress of the Facilities.
Other duties assigned by management.

任职资格：
M.S.in chemical engineering and biological engineering discipline with minimum of 15 years of biotech experience in biopharmaceutical process and facility engineering; PhD degree in the same discipline with minimum of 10 years of related experience.
Hands-on experience in design/build and C&Q of the biopharmaceutical commercial facility.
Strong collaboration, communication and influence skills.
Good knowledge and experience in GMP, Quality System, EHS.
PMP certificate is preferred but not required.
Proficient in AutoCAD, PLC and P&ID.
Fluent in written and verbal English communication.



无锡site

自控与信息管理部
1. Automation Engineer
岗位职责：
参与高可用应用服务系统的规划设计、安装部署、调试。
负责系统的日常维护、监控、备份、升级。
负责系统应急故障处理，保障系统稳定运行。
编写自动化工作脚本。
负责为其他技术人员进行技术支持和培训。

任职资格：
计算机、软件工程、通信工程等相关专业大专及以上学历。
两年以上相关岗位工作经验。
精通WindowsServer2003/2008/2012系统，熟练安装/配置AD、DNS、Cluster、NLB等。
具备MCSE资质优先。
熟悉VMware、Hyper-V、Citrix虚拟化技术优先。
了解分布式存储，对SAN有经验者优先。
懂得.NET、Java、Python、PowerShell开发者优先。
懂得SQL，有Oracle、SQL Server等数据库系统操作经验优先。
较强的英文阅读能力，能读懂技术文档。
热爱学习新知，逻辑分析能力强，良好的口头和书面沟通能力。
工作认真负责，有团队合作精神。


商业生产部
2. 细胞培养工程师
岗位职责：
细胞的复苏解冻，细胞在摇瓶和反应器中的扩增培养以及细胞在反应器阶段的生产。设备操作包括但不限于：摇床，震荡生物反应器（RM），一次性生物反应器（STR, SUB），离心机，显微镜，水浴锅和天平。
与工程部、QA部门以及QC部门相互合作，推进生产的顺利进行。
参与部门文件的撰写或升版工作，比如SOP，验证文件（SAT, IQ和OQ等）批记录的撰写等。
参与车间内仪器设备的日常维护管理和相关SOP的撰写。
参与报告的撰写或项目汇报。
参加cGMP培训并遵循cGMP规则在车间内完成生产任务。

任职资格：
本科及以上学历；微生物、生物化学、生物制药和发酵工程等专业尤佳。
英语4级以上，有一定的英文文件阅读理解能力。
有一年及以上相关生物制药行业GMP工作经验者优先考虑。
精神面貌良好，有激情，有活力。


3. 蛋白纯化工程师
岗位职责：
在一定监督下于cGMP生产设备中执行所有的操作以生产活性药物成分。具体职责包括：溶剂/缓冲液的准备，装柱，蛋白纯化工序（柱色谱，病毒灭活，病毒截留和超滤）。设备操作包括但不限于：色谱系统，过滤装置，超滤装置，病毒截留系统，UV/VIS分光光度计，泵，管道焊接工/密封者，水浴锅和天平。必须与工程部、设备处、验证处、QA部门、QC部门、程序开发及原材料管理部门相互协作。
必要时与原材料及设备提供商和商业合作伙伴作进一步的交流。
参与FAT（工厂验收试验）和/或SAT（实地验收试验）和/或IOPQ（装置/操作/工序资格认证）。
能够阅读/理解cGMP的中英文文件。
参加修订/创建/复审诸如SOP、MBR、验证/资格认证协议类的cGMP文件和FAT/SAT文件。
参加cGMP培训并遵循cGMP规则。

任职资格：
大学本科（或者大专但有2年以上制药相关经验）；化学、生物化学、生物制药、工程、发酵、纯化等专业尤佳。
英语4级以上。
有一年及以上相关生物制药行业GMP工作经验。
精神面貌良好，有激情，有活力。


质量控制部
4. Scientist of Analytical Science Technology
岗位职责：
Perform analytical method optimization, qualification/validation.
Generate and review technical documents such as methods, qualification/validation protocols and reports.
Serve as technical lead to solve technical challenges and support laboratory investigations.
Perform QC release/stability testing as necessary.

任职资格：
Graduate degree in analytical chemistry, biochemistry, molecular/cell biology or related fields.
Candidates with Ph.D degree or MS degree have minimum 2 year of relevant industry experience.
Knowledge and expertise in at least one of the following fields.
Biochemical assays such as ELISA, cell based assay, qPCR, Western blot, enzyme activity testing.
Separation assays such as HPLC, CE, gel electrophoresis.
Biophysical assays such as MS, spectroscopy (UV, FTIR, CD, fluorescence, etc.), DSC.
Strong communication skills in English and Chinese, fluent in speaking, writing and reading in both languages.
Critical thinking, scientific reasoning and problem solving skills.


5. Project Coordinator
岗位职责：
Work with the CMC team of projects and understand the scope of the project and all vital aspects related to QC activities.
Serve as the liaison of QC and communicate with the client and other stakeholders in a project.
Gather and convey project information to the QC team and ensure that all team members understand the scope and deliverable of the project.
Prepare and track the schedule of QC activities and ensure that the QC part of the project is carried out on time.
Prepare GMP documents.
Ensure that the project is carried out in compliance with cGMP regulations.

任职资格：
Education background in chemistry, biology, or pharmaceutical sciences.
Degree of Master or above is preferable, or a Degree of Bachelor with at least two years of pharmaceutical industry experience.
Outstanding oral and written communication skills in both English and Chinese are preferred.
Good project management, time management, and multitasking skills are required.
Able to work independently and as a good team player.


6. 微生物研究员
岗位职责：
Perform tests as below and Provide quality reports based on all lab test data according to SOP:
       1) Endotoxin（LAL）test
       2) Particles Control for Clean Room
       3) Microbiological Monitoring for Clean Room
       4) Bioburden Test
       5) SterilityTest
       6) Microbiological test for initial, In-process
           and final products
       7) Medium preparation, preservation and
           growth promotion test
Write and revise SOP, protocol and other technical documentation as necessary.
Responsible for lab test strains, BI, culture media, Test reagent/solution management and use, keep all materials to be used within their shelf life.
Participating in sterility test methods validation and routine stability tests.
Perform the analysis for microbe category and it’s trend in the plant so as to improve the controlling.
Take part in the GMP audit to the related working area.
Understand and implement company, division and regulatory EHS requirements as applicable to this position.
Any other work authorized by manager.

任职资格：
Master degree in a science/technical field such as Pharmacy, Biology, Microbiology.
2 years or more work experience as microbiologist roles in Pharmaceutical industry or associated industries.
Experience work in sterile product companies, familiar with GMP, GLP and pharmacopeia are preferred.
Comprehensive knowledge of microbial testing, environmental monitoring, validation, etc. in Pharmaceutical area.
Good English skills.
Experience in Kinetic Turbidimetric Assay/ Kinetic-chromogenic assay (LAL).


项目管理部
7. Group Leader/AssistantDirector/Associate
    Director/Director, Project Management
岗位职责：
Define scope and build up timeline for the project while working closely with the project CMC leader.
Identify the critical path activities in the timeline and keep the internal staff and the client informed.
Coordinates the internal resources and leads WuXi's efforts for timely completion of projects by interacting with the client and internal technical staff.
Holds regular meetings with team members and with clients to update progress as appropriate. Response for meeting agenda, minutes and action items follow up.
Keep clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable means.
Monitor timeline and contract for accuracy and follows up on any discrepancies with clients and/or internal personnel.
Confirm the completion of work by stage with client and ensures invoices are sent to client for processing.
Act as a team leader and provide the training, guidance, feedback and review to the team members as needed.

任职资格：
Bachelor degree in science/engineering field with 3/5/6/8 years, or Master degree with at least 1/3/4/6 years of working experience in the pharmaceutical or industrial biotech field.
Experience in biological drug development and project management is preferred.
Good English skills, both written and oral.
Ability to work independently with limited supervision in a fast-paced environment.
Excellent verbal and written communication skills.
Ability to work as a team member and as a leader.
Good multi-tasking and prioritization skills.


生产部
8. Manufacturing Project Leader/
    生物制药生产项目管理
岗位职责：
Lead tech transfer for the designated production projects at MFG1.
Lead the tech transfer activities including gap analysis, manufacturing process discussion, manufacturing document preparation.
Clearly understand status of tech transfer, production progress and technical challenges/achievement of production projects, and make appropriate presentation to clients and management.
Ensure clients requirements are clearly communicated to production team and management.
Write technical and production reports per requirement of the projects assigned.
Lead/support for preparation and hosting of regulatory inspection and client/QP audit of MFG1 for projects assigned.
Participate in the review/translation of production batch records, deviation, change control, CAPA and regulatory observation response of projects assigned.
Address regulatory observations/audit findings and CAPA of projects assigned.
Participatein PD/MFG1/MFG2 technology communication and MFG1 manufacturing summary, more specifically continuous improvement of
PD/MFG1/MFG2 platform technology alignment.
Optimization of production execution processes.
Reduction of deviations/investigations from technology aspect.
Assist Head of MFG1, more specifically.
Host client visit and present overview of MFG1 facility and capability.
Participatein production process optimization.
Ensure projects production schedule are met.
Help training in GMP, technology, lean sigma.
Other temporary tasks assigned by Head of MFG1 and Site Head.

任职资格：
Doctor, Master or Bachelor degree in Biology, Pharmacy, Biochemistry, Biotechnology or other related majors and be familiar with cell culture or protein purification.
Good logical ability and can author protocol, reports and other documents assigned in Chinese and English.
Good communication and cooperation ability and skills to coordinate the team work.
Have hands-on experience on cell culture or purification process development or GMP manufacturing/support.


生产科技部
9. Technic Transfer Engineer/技术转移工程师
岗位职责：
Tech Transfer Lead & Functional Leader
Lead and complete the new production introduction assessment.
Partner with Process Development to ensure successful process transfer.
Monitor the manufacturing process, when the situation is needed need to be observe or provide recommendation on-site.
Serve as a reviewer of tech transfer protocol, MBR, PFD, manufacturing related documentation, etc.
Attend project meetings.
Upstream, Downstream, and Formulation, Fill and Finishing Process Science
Perform the satellite run activates including upstream and downstream.
Lead cross functional technology transfer teams for upstream and downstreamoperations.
Serve as the science and technical expert during the tech transfer, gapanalysis, troubleshooting of manufacturing processes
Perform satellite run upstream and downstream activates and analysis
Design and perform deviation related experiments to determine and understandthe possible cause factors that related to the event.
New manufacturing equipment evaluation design and planning.
Lead cross functional technology transfer teams for aseptic formulation andsterile filling and finishing operations.
Process Performance Qualification
Lead PPQ/PV (process performance qualification or process validation)preparations & execution.
Participate/contribute to PC (process characterization).
Deviation investigation
Lead or participate in key investigations of deviations.
Communicate with the client regarding the deviation investigation results.
Investigate, identify root cause, and identify CAPA for manufacturing deviations.

任职资格：
Educationand working experience.
Category1: B.S. in Biology, Biochemistry, Chemistry, Biochemical engineering,Chemical Engineering, and Life Science related majors, with 2-5 years pharmaceutical, manufacturing, QC, QA, Process Development, Food science related experience.
Category2: M.S. in Biology, Biochemistry, Chemistry, Chemical Engineering, and Life Science related majors, with 2-5 years pharmaceutical, manufacturing, QC,QA, Process Development, Food science, related experience.
Category 3: M.S. or Ph.D. in Biology, Biochemistry, Chemistry, Chemical Engineering, and Life Science related majors, with 5< years pharmaceutical, manufacturing, QC, QA, Process Development, Food science, related experience.
Strong written, reading, and oral English communication skills.
Must be able to work within multifunctional teams.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to effectively present information to top management, public groups, and/or boards of directors.
Familiar with cGMP and CMC.
Authortechnical reports and protocols in support of cGMP activities.
Management and manufacturing experience is preferred someone with over 8 years’ experience.


生物制药生物工艺部
10. 样品标准品管理员
岗位职责：
负责样品管理工作，包括但不仅限于样品收发、申请检测、样品整理、报告整理、相关台帐。
负责标准品管理、分装、领用、相关台帐。
撰写相关的SOP。

任职资格：
具备良好的学习能力、思维能力；团队合作、沟通协调能力；综合统筹管理能力和执行力。
上进心强，注重细节，善于总结归纳，做事条理性强。
熟练使用Office和其它办公软件。
专科学历，生命科学相关专业优先。
具有较强的英文读写能力。


11. 生物制药蛋白分析研究员（生化方向）
岗位职责：
基于ELISA,UV,SDS-PAGE,WB,IEF,qPCR等技术对蛋白的理化性质进行检测，包括但不限于SDS-PAGE, WB, ELISA, qPCR检测等。
负责分析方法的开发、确认、验证和方法转移工作。
负责撰写相关实验的SOP和方法开发报告等文件。
依照SOP在规定期限，分析实验数据、书写检验记录，完成实验报告。
参与实验室仪器等设备、耗材的日常维护。
配合并完成组内其它工作。

任职资格：
有SDS-PAGE,WB, ELISA, qPCR分析技能之一均可。
工作年限：硕士学历并有2年以上相关工作经验，本科学历具有4年以上相关工作经验。
专业：生物制药，生物化学，免疫学及分子生物学专业等相关专业。
学历：本科以上学历。
语言能力：有较好的英语读写能力，能够阅读与本职工作相关的英文信息和资料。
是否需要管理经验：不做要求。
性别：不做要求。
工作认真负责，态度积极主动，勤奋好学，善于思考，责任心强。
做事条理性强且能高效工作，具有良好的沟通协调与团队奉献精神。


12. AS Analytical Scientist-HPLC
Develop methods (plan, design and execute experiments) with HPLC/UPLC for protein analyses or small molecule residue analysis.
Familiar with analytical methods development, optimization, and qualification.
Operate and maintains HPLC or UPLC instruments.
Follow written instructions (e.g. SOPs, test methods) to execute experiments independently.
Have experience on fraction collection of biomolecule or chemical compound.
Analyze, interpret, and summarize data; present results at internal meeting.
Prepare documents including data summaries, technical and analytical reports.
Train and orientate new lab members.

任职资格：
M.S.degree or bachelor degree with more than one-year relative experience in biochemistry, protein science, analytical chemistry or a related discipline with training in HPLC.
Solid knowledge on the HPLC theories and technologies, and hands-on experience in operating, maintaining and troubleshooting of HPLC.
A good team player with excellent interpersonal and communication skills (bothwritten and verbal) and able to present data effectively.
Strongproblem solving and troubleshooting capabilities; proactive and self-motivated.
Experience with protein analytical skills (HPLC or CE related) and knowledge about antibody/biologics analysis is a plus.
Experience with detecting and quantifying process residues or charge variants analysis is preferred but not required.


质量保证部
13. DP On-line QA Specialist
岗位职责：
负责生产现场日常检查，确保各项操作规程、批记录得到有效执行。
作为QA与其他部门沟通桥梁，及时报告生产过程中的问题。
参与生产相关偏差、变更、CAPA和OOS的处理。
配合自检，客户，及法规部门审计工作。
完成领导交办的其他工作。

任职资格：
本科及以上学历，生物学，药学及其他相关学历。
了解cGMP法规及ICH。
具备两年以上药厂相关工作经验。
具有良好的沟通技巧和团队协作精神。
具有良好的英文读写能力。
熟练使用计算机办公软件。


14. MFG On-line QA Specialist
岗位职责：
USP&DS生产现场的日常监控及房间放行。
负责上游细胞培养和下游蛋白分离纯化（USP&DSP）相关的SOP等质量文件的审核。
负责上游细胞培养和下游蛋白分离纯化（USP&DSP）的主批记录（MBR）及批记录（BPR）的审核。
负责上游细胞培养和下游蛋白分离纯化（USP&DSP）相关的偏差、变更及预防纠正措施的审核。
负责细胞库的日常管理。
负责原液（DS）放行相关文件的审核。
配合公司自检及日常审计工作。

任职资格：
具有药学、生物学、化学相关专业本科以上学历。
了解中国GMP，欧盟GMP及ICH等法规指南内容者优先。
具备生产或检验相关工作经验者优先。
良好的沟通协调能力。
良好的计算机软件办公技能。
良好的英文读写能力。
细心、并能在快速的工作环境下指导生产及QC做出与质量相关正确的决定。


15. QA Training Coordinator
岗位职责：
组织和协调工厂所有GMP人员GMP培训计划。
实施并促进工厂GMP课堂培训以及岗位培训的标准化。
建立并维护工厂所有员工的GMP培训计划。
建立并修订培训相关的评估材料以符合预期用途。
能够领导并协调工厂内GMP人员的培训相关活动。
保存GMP培训相关的培训记录。
负责原液（DS）放行相关文件的审核，配合公司自检及日常审计工作。

任职资格：
具有药学、生物学、化学相关专业本科以上学历。
了解中国GMP，欧盟GMP及ICH等法规指南内容者优先。
具备生产或检验相关工作经验者优先。
良好的沟通协调能力。
良好的计算机软件办公技能。



苏州site

生物安全实验室
1. 细胞生物研究员
岗位职责：
Conducts cell-based assays based on cell culture techniques.
Conducts lab procedures according to and in compliance with GLP, cGMP, SFDA guidelines and SOPs.
Perform cell-based assays on customers materials and then assesses cell growth characteristics.
Accurately completes batch records and other required documentation according to and incompliance with GLP, cGMP, CFR and Chinese FDA guidelines and SOPs.
Maintains laboratory notebook and follows all general and laboratory SOPs.
Performs assays using appropriate laboratory techniques for lab group assigned to.
Reports observations of ongoing tests to Study Director or Laboratory Manager.
Communicates with supervisor and other colleagues re: daily lab activities.
Demonstrates proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
Correctly analyzes scientific data with accuracy and precision.
Contributes to the preparation and revision of technical documents and reports.
Prepares reagents and completes reagent batch records.
Checks reagents for expired chemicals and disposes of any expired reagents.
Performs routine equipment monitoring and cleaning (i.e. centrifuges, biosafety and chemical hoods, refrigerators, incubators and freezers) and keeps records according to guidelines and SOPs.
Communicates inventory needs to supervisor.
Prepares samples to be sent out to other labs as needed.
Completes all requisite training (i.e. Blood borne Pathogen, Quality Assurance, safety,etc.).

任职资格：
Bachelor’s degree with major in Biological Sciences or science related major or equivalent training and/or experience. Knowledge and/or experience with cell culture and viruses is an advantage but not absolutely necessary.
Understand aseptic technique.
Understanding oral and written English.


2. 微生物研究员
岗位职责：
负责微生物实验室微生物培养和检测。
负责微生物PCR检测及PCR检测项目的统筹安排。
负责遵照GLP、cGMP、GMP等及时完成客户样本等各项检测。
负责相关实验结果的整理并出具实验报告。
负责相关设备的监控及维护。
负责微生物检测部门物料的请购。

任职资格：
微生物学，生物学专业或相关专业本科及以上学历。
熟悉微生物及细胞培养。
精通PCR检测。


3. 分子生物研究员
岗位职责：
参与分子生物学实验室相关的生物安全实验检测。
履行生物安全检测实验的最新需求。
准备和执行实验方案和SOPs；如果需要，帮助准备和修改文件。
按照GLP、cGMP及中国FDA及其他管制条例进行实验和研发项目并保存记录。
完成所有必需的的培训项目（如病原体、质量管理、安全培训等），必要时，参与其他科研活动。

任职资格：
硕士或本科，本科需有一年以上分子生物学相关实验室工作经验。
能独立完成PCR、荧光定量PCR等相关实验，动手能力强，具有实际操作经验、分析能力和问题解决能力。
技术要求：DNA、RNA抽提、DNA电泳、PCR、荧光定量PCR、基本生物信息学软件应用等。
负责实验室环境及仪器的日常维护，配合实验室管理工作的开展。
英文良好，可以独立查阅文献，处理实验中相关技术问题。
热爱实验室工作，有较强的责任心、耐心细致，具备良好的沟通和团队合作能力。熟悉GLP/GMP相关法规者优先。


4. 病毒清除研究员
岗位职责：
参与病毒清除部相关客户项目的研究。
按照符合GLP / cGMP标准的研究方法，按时完成客户样品测试。
按照SOP要求，完成批记录及其他文件的填写。
与公司内部各部门进行有效沟通，解决项目中出现的问题。
负责实验室设备的日常监控和清洁，并根据SOP的要求进行记录。
当被管理层指派为客户项目的专题负责人时，行使相关职责。
完成部门领导分配的其他任务。

任职资格：
掌握细胞生物学、分子生物学、微生物学以及蛋白纯化等方面的理论知识。
熟练掌握动物细胞培养和无菌操作等实验技能。
有病毒学研究经验的优先。
能熟练操作AKTA蛋白纯化系统的优先。
精通qPCR实验技术的优先。


5. 病毒检测研究员
岗位职责：
Conducts virology assays based on cell culture, molecular orimmunological techniques.
Conducts lab procedures according to and in compliance with GLP, cGMP,  SFDA guidelines and SOPs.
Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and Chinese FDA guidelines and SOPs.
Maintains laboratory notebook and follows all general andlaboratory SOPs.
Performs assays using appropriate laboratory techniques for labgroup assigned to.
Reports observations of ongoing tests to Study Director or Laboratory Manager.
Communicates with supervisor and other colleagues re: daily labactivities.
Demonstrates proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
Correctly analyzes scientific data with accuracy and precision.
Contributes to the preparation and revision of technical documents and reports.
Prepares reagents and completes reagent batch records.
Checks reagents for expired chemicals and disposes of any expired reagents.
Performs laboratory maintenance (i.e. decontaminates and disposes of medical. and other waste as appropriate, maintains laboratory supply inventories, keeps work surfaces clean and neat) and keeps records of maintenance according to guidelines and SOPs.
Performs routine equipment monitoring and cleaning (i.e.centrifuges, biosafety and chemical hoods, refrigerators, incubators and freezers) and keeps records according to guidelines and SOPs.
Communicates inventory needs to supervisor.
Prepares samples to be sent out to other labs as needed.
Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.).

任职资格：
Bachelor’s degree with major in Biological Sciences or science related major or equivalent training and/or experience. Knowledge and/or experience with viruses is an advantage.
Proficient with mammalian cell culture and aseptic technique is an advantage.


6. 电镜专业技术人员
岗位职责︰
基于电镜技术开展病毒学检测实验，包括负染法和超薄切片法样品制备和图像获取。
操作并维护生物实验室电镜设备。
能进行数据分析，确保所有的实验数据和记录的准确性、完整性、有效性和可靠性。
能解决电镜实验相关的技术问题，并可确保设备处于高效运转。
为其他技术人员提供包括样品制备、电镜操作以及图像分析等培训。
定期向专题负责人或实验室主管报告正在开展的工作项目。
与主管和其他同事积极沟通实验室的日常活动。
在实验室工作完成过程中展现出严谨的科学理论背景和严格的实际应用能力。
能够准确、精确地分析科学数据。
编写、修订与审阅的技术文件和报告。

任职资格：
大学本科或以上学历，生物科学或相关专业，或相关专业培训和/或经验。具有电镜方面的工作经验和知识背景，二年或二年以上电镜经验，具有生物样本电镜分析经验者优先考虑。
有研发或使用病毒的经验优先考虑。
有病毒学或细胞培养的知识和经验优先考虑。
岗位和级别将根据应聘者学历、经验及背景而定。


检验部
7.   设备验证专员
岗位职责：
新设备接收，调试，安装以及旧设备的停用，退役等。
设备台帐维护，更新。
设备维修及预防性维护（包括联系供应商）。
安排相关设备的外部校准/检定。
相关SOP撰写及修订。
公司安排的与岗位相关的其它工作。

任职资格：
本科学历，工程/电子方面专业。
有基本的计算机硬件和软件技能。
英语水平大学英语四级或同等资质。
能独立工作,有团队精神,可以同时进行多项工作;有管理经验者优先。
更加满意熟悉GxP质量体系, ISO 17025。
至少两年设备维修方面的工作经验。


质量保证部
8. QA审核员
岗位职责：
根据内部外部的标准及全球相关法规要求（GMP，GLP及公司SOP）来评估研究的符合性。准备和签署法规文件，如质量声明及测试相关GMP文件。在目标时限内及时提供在GLP/GMP领域的符合性评估。在GMP/GLP法规检查时或客户参观/审核时进行陪同和联系。
执行对全球法规递交相关的研究的检查/审核。将QA发现问题汇报至工厂管理层及主责研究员，及相应CAPA管理追踪。
为所有GLP和GMP领域的问题提供反馈和指导。在检测公司内为系统或流程审核并提供QA建议及输入。
计划和实施必要的QA监控系统以确保对内部标准和全球法规要求的符合性，以支持客户在全球的法规递交。提供培训、撰写及审核QA SOP，开展系统、流程和验证审核，管理QA记录并评估苏州及供应商设施的符合性。计划必须的QA项目及批准QA报告。
开展研究、设施、流程及供应商的检查/审核，将发现问题报告至管理层（检测实施及主责研究员），维护及完成对分配的研究/计划的检查/审核文件。
计划及执行QA相关检查。
审核GLP研究方案、批记录、最终报告及相关文件并为最终报告准备QA声明。
QA物料放行。
审核GMP研究批记录、最终报告、分析证书及相关文件。
客户访问/审核联系。
协助准备QA审核技巧、表格及检查清单并准备和审核/批准QASOP 及质量流程。
法规检查联系。
对QA及法规问题及质量管理体系提供建议。
支持/审核计算机验证项目及活动。
审核文件或SOPs 的中英文翻译。
维护QA记录和主计划并支持QA趋势分析。
QA日常事务处理（如NCE、LIR、CAPA、物料放行、供应商管理等）。

任职资格：
自然科学及相关领域专业。
良好的人际交流能力。
良好的口语和书面英语能力。
熟悉GLP/GMP法规要求。
科学及数学术语及计算的理解力。


9. QA Assistant Director
岗位职责：
Conduct inspections/audits of studies, facilities, processes, systems and vendors, report observations to management, both test facitlity and line and study directors, and maintain complete inspection/audit files on assigned studies/projects.
Schedule/conduct inspections of QA activities.
Audit study protocols, batch records, final reports and associated amendments and prepare QAU statements for final reports within all GLP areas.
Audit study batch records, final reports, certificates of analysis and associated amendments within all GMP areas.
Interact with all levels of management of all GLP and GMP areas.
Interact with clients during visits/audits.
Assist in the preparation of QA audit techniques, forms and checklists and prepare and review/approve QA SOPs and quality processes.
Interact with regulatory authorities during inspections.
Provide advice/consultation on QA and regulatory issues and quality management systems.
Support/audit computer validation projects and activities.
Review Chinese/English translated documentation or SOPs.
Review SOPs for compliance with GLP and GMP regulations.
Conduct internal GLP/GMP Quality training programs.
Maintain QA records and Master Schedule and implement and support QA trend analysis.
Review and approve QA documents including but not limited to audit reports, QA statements and QA SOPs.
Sign for QA Management review of protocols and reports and associated amendments, as necessary, for Chinese submission.
Act as Deputy for Director of QA for the Biosafety Testing Labs for designated responsibilities.

任职资格：
Degree in Natural Sciences or comparable related experience.
At least 10 years experience in product development, includingauditing/inspecting against regulatory standards and/or work in a GLP/GMPfacility.
At least 3 year experience in managing personnel either as directsupervisor or deputy for departmental management.
Good interpersonal and communication (written and oral) skills.
Good understanding both written and oral of English language.
Understanding of regulatory (GLP/GMP) requirements.
Ability to comprehend scientific and mathematical terminology and calculations.


项目管理部
10. 项目管理专员
岗位职责：
提供全面的项目支持，同时协助和协调所有项目的可交付成果。项目协调员还将研究和汇编信息，跟踪进度，更新跟踪和报告，以确保所有的交付物都能按时完成。接受上级部门人员的监督。
项目更新、数据、文件的接收和传达；确保修正和偏差在适当的时间范围内提交。
确保数据的完整性和所有项目的质量达到可接受的质量水平，包括跟踪和存储研究材料和实验室记录。
参与实验室项目的执行。
监控项目时间表和里程碑，以确保项目按时交付。
维护项目文档、大纲和项目进行中数据。
组织、汇总、分析数据和实验室记录。
协调测试样本的接收和处理。
制定、准备和管理部门标准操作程序及其他与项目有关的文件。
报告的编写。
其他相关工作职责。

任职资格：
大学本科以上学历，生物科学或相关专业，或相关专业或相关专业的培训和/或经验。职称将依据经验决定。 返回小木虫查看更多