药明生物最新职位(无锡篇)

药明生物（WuXi Biologics）是药明康德的生物制药一体化服务平台，由无锡药明康德生物技术股份有限公司、苏州药明康德检测检验有限责任公司和上海药明生物技术有限公司组建而成。

目前，公司研发团队规模达到1200多人，有120多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产（CDMO）团队，诚挚欢迎同样优秀的你。

若您对以下职位感兴趣，可将中英文简发送至HR_Biologics@wuxiapptec.com，并在邮件标题注明“应聘岗位+姓名”。联系人：魏女士（0510-81831262）

招聘职位列表

· 商业生产部(无锡)-UpStream Production Manager/Supervisor

· 商业生产部(无锡)-DownStream Production Manager/Supervisor

· 质量控制部(无锡)-仪器分析研究员

· Project Management(无锡)-Project Manager

· Process Engineering &Validation(无锡)-CSV & ERES Compliance Director

· 质量控制部(无锡)-Microbiology Scientist/ Senior Scientist

· 质量控制部(无锡)-蛋白分析研究员(bioassay方向)

· 质量控制部(无锡)-蛋白分析研究员(Enzyme activity方向)

· Operations(无锡)-实验室信息技术经理

· 质量保证部（无锡）- Quality Systemspecialist

· 质量保证部（无锡）- QC On-line QASpecialist

· 质量保证部（无锡）-QA Engineer

Job Descriptions

招聘部门：商业生产部（无锡）

招聘岗位：UpStream Production Manager/Supervisor

岗位职责：

· 负责进行上游细胞培养的所有生产活动并确保批生产活动符合当前GMP的要求。

· 在有限的指导下能够独立执行生产项目并领导员工按计划完成生产任务。

· 及时向领导反馈工艺、人员、安全、生产环境、维护及其他问题。

· 启动偏差，领导调查工作、变更实行及纠正和预防措施的执行。

· 负责维护GMP车间的安全运行状态，进行组内员工的安全教育及监督。

· 负责生产物料采购、跟踪、管理，，必要时与供应商或经销商等沟通联系。

· 与工程或相关部门沟通协调设备厂房的维护维修及计量工作。

· 起草审阅GMP文件，包括但不限于SOP/MBR/URS/FAT/SAT，审核批生产记录。

· 确保组内成员及时完成培训，按cGMP的要求有资质执行所需操作。

· 负责指导并发展下属员工，领导团队建设。

· 主动开展业务优化并持续改进。

· 负责组内及部门的日常管理事务。

职位要求：

· 专科及以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员。

· 具有上游细胞培养等GMP生产操作的相关知识或经验，至少具有2年生产管理经验。

· 具有优秀的沟通表达能力，以及良好的口头和书面英语水平。

· 具有杰出的管理和领导能力者优先。

· 具有吃苦耐劳的品质及良好的身体素质（至少提起15Kg的重物）。

· 工作积极向上并具有优秀的持续学习能力。

 

 

招聘部门：商业生产部（无锡）

招聘岗位：DownStream Production Manager/Supervisor

岗位职责：

· 负责进行下游纯化的所有生产活动并确保批生产活动符合当前GMP的要求。

· 在有限的指导下能够独立执行生产项目并领导员工按计划完成生产任务。

· 及时向领导反馈工艺、人员、安全、生产环境、维护及其他问题。

· 启动偏差，领导调查工作、变更实行及纠正和预防措施的执行。

· 负责维护GMP车间的安全运行状态，进行组内员工的安全教育及监督。

· 负责生产物料采购、跟踪、管理，，必要时与供应商或经销商等沟通联系。

· 与工程或相关部门沟通协调设备厂房的维护维修及计量工作。

· 起草审阅GMP文件，包括但不限于SOP/MBR/URS/FAT/SAT，审核批生产记录。

· 确保组内成员及时完成培训，按cGMP的要求有资质执行所需操作。

· 负责指导并发展下属员工，领导团队建设。

· 主动开展业务优化并持续改进。

· 负责组内及部门的日常管理事务。

职位要求：

· 专科及以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员。

· 具有下游纯化等GMP生产操作的相关知识或经验，至少具有2年生产管理经验。

· 具有优秀的沟通表达能力，以及良好的口头和书面英语水平。

· 具有杰出的管理和领导能力者优先。

· 具有吃苦耐劳的品质及良好的身体素质（至少提起15Kg的重物）。

· 工作积极向上并具有优秀的持续学习能力。

 

 

招聘部门：质量控制部（无锡）

招聘岗位：仪器分析研究员

岗位职责：

· 负责质量部的原辅料、中间产品、成品的仪器分析工作，及时完成检验记录和报告，保证测试结果准确有效。

· 负责起草、审核分析方法、仪器操作与维护等相关SOP工作；

· 负责仪器分析实验室设备的日常维护等工作；

· 负责进行药物质量分析方法的建立以及方法验证、图谱解析等工作；

· 负责企业物料和产品的质量标准制定及稳定性研究等工作。

职位要求：

· 药物分析，分析化学或药学等相关专业本科以上学历；

· 有2年以上制药行业化学分析、药物分析实验室工作经验，熟悉GLP和GMP实验室法规要求；有生物制药行业工作经验者优先；

· 至少能熟练使用HPLC、LC-MS、cIEF、CE等分析仪器中的1-2种仪器，熟悉仪器分析实验室基本操作流程；有分析方法验证经验者优先；

· 良好的英文读写能力，能阅读翻译相关英文文献。

· 细心，具有较强的责任心和学习能力，沟通能力良好，能吃苦耐劳。

 

 

招聘部门：Project Management （无锡）

招聘岗位：Project Manager

岗位职责：

·  Leads the project team to fulfill the contractrequirement and meet the client’s need for CMC development or manufacturingprojects as appropriate.

·  Tracks the progress of projects and coordinatesWuXi's staff and resources to meet project deadlines in a timely and efficientmanner.

·  Disseminates and facilitates informationflow/exchange among WuXi departments and between the client and WuXi.

·  Manage scope change in project execution and assistto sign supplementary agreement for it.

·  Holds regular internal project meetings to discussand plan the projects.

·  Holds regular meetings with clients to updateprogress via teleconference or site visits as appropriate.

·  Maintains records to document all relevantcommunications related to projects.

·  Copies files and mails final reports.

·  Help Service Department to generate invoices andsend them to the client.

·  Maintains the WuXi standard quality and format ofcommunications (e.g. letters, proposals, reports, etc.) and overallharmonization of documentation at the corporate level.

·  Monitors timeline and contract for accuracy andfollows up on any discrepancies with clients and/or internal personnel.

·  Assists with training of team members asappropriate.

·  Tracks and confirms client materials transferinformation.

·  Performs other duties as required.

职位要求：

·  BS/MS/PhD with major in Biological Sciences,Chemical engineering, or equivalent training plus 1 or more years projectmanagement experience or equivalent training and/or experience.

·  Ability to accomplish the described duties throughthe use of appropriate computer equipment and software (i.e. Microsoft Word,Excel, PowerPoint, Project and Outlook) and general office equipment (i.e.photocopier, fax machine and phone equipment).

·  Ability to accurately and reproducibly performarithmetic calculations including fractions, decimals and percentages.

·  Ability to use judgment as dictated by complexity ofsituation.

·  Ability to work under limited supervision and tohandle problems of a more difficult nature.

·  Ability to interpret written instructions and towrite form letters and routine correspondence.

·  Ability to understand and follow verbal ordemonstrated instructions.

·  Ability to receive and comprehend and to effectivelycommunicate detailed information through verbal and written communication.

·  Ability to prioritize tasks in fast paced workenvironment.

·  Ability to work effectively as part of a team and toexhibit effective interpersonal skills.

·  Ability to build rapport with internal co-workersand clients in such a way as to maximize quality of client service.

 

 

招聘部门：Process Engineering & Validation（无锡）

招聘岗位： CSV & ERES Compliance Director

岗位职责：

·   PositionSummary:
·   This position ensures compliance ofcomputerized systems and associated processes with Wuxi Bio, and expectationsof Regulatory authorities, including but not limited to a complete system lifecycle approach to computerized systems with a focus on 21 CFR Part 11compliance and validation using current industry norms (e.g. GMAP 5, PQLI(ISPE), ICH , PI C/S and ASTM E55). The primary responsibility is to providethe quality oversight to ensuring life cycle validation and compliance ofcomputerized systems and their associated platforms working with the systemowners and end users as key stakeholders.

·   Essential JobResponsibilities:

·  Automation and CSV for WuXi Biologics in general andthe Wuxi Bio MFG2 facility in particular.

·  Establishing ERES and CSV/computerized system EREScompliance part of QMS (QM part, QSGs, SOPs and CSV validation/compliancedocuments).

·  Working closely with QA, QC, MFG/FFF, ENG, Operationand IT to achieve and maintain Computerized Systems and ERES compliance.

·  Lead and act as the key contact person / SME for allissues related to Computerized Systems and ERES compliance during routinequality operation, internal/external audits, health authority (HA) inspectionsand client communication.

·  Serve as a Computerized System Validation SubjectMatter Expert and provide strategic guidance. Determine and establishvalidation requirements for computerized systems based on SOPs and regulatorystandards (FDA, EMA) to ensure compliance and maintain an inspection readystate.

·  Lead the development of system specific validationplans and strategy using a risk-based approach.

·  Provide (modular) training of validation engineersand / or consultants to effectively produce validation deliverables followingCSV SOPs and FDA 21CFR Part 11 requirements.

·  Provide regular updates related to keyaccountabilities and scope of the job to senior management.

·  Ensure quality of CSV deliverables for regulatedsystems and quality of non-regulated systems.

职位要求：

·  BS in Engineering, Computer Sciences, or relatedfield.

·  At least 10 years of working experiences in thefield of computerized system validation in the pharmaceutical industry.Additionally, have more than 5 years of working experiences in engineeringfields.

·  An expert in related regulatory requirements andindustry standards, such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, GAMP 5,ICH Q9/Q10.

·  Proficiency in: Trackwise, SAP, LIMS, MES, DCS,Empower, automation, and other pharmaceutical IT systems; Data ManagementSystems.

·  Proficient speaking and writing in English. Havingsimilar skills in Chinese is a plus. Excellent technical writing skills inEnglish is required.

·  Excellent training skills for providing bothclassroom training and on the job training of CSV and ERES compliance.

 

 

招聘部门：质量控制部（无锡）

招聘岗位：Microbiology Scientist/ Senior Scientist

岗位职责：

·  Perform tests as below and Provide quality reportsbased 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)Sterility Test

·  6)Microbiological test for initial, In-process andfinal products

·  7) Medium preparation, preservation and growthpromotion test

·  Write and revise SOP, protocol and other technicaldocumentation as necessary.

·  Responsible for lab test strains, BI, culture media,Test reagent/solution management and use, keep all materials to be used withintheir shelf life.

·  Participating in sterility test methods validationand routine stability tests.

·  Perform the analysis for microbe category and it’strend in the plant so as to improve the controlling.

·  Take part in the GMP audit to the related workingarea.

·  Understand and implement company, division andregulatory EHS requirements as applicableto this position.

·  Any other work authorized by manager.

职位要求：

·  Master degree in a science/technical field such asPharmacy, Biology, Microbiology.

·  2 years or more work experience as microbiologistroles 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.

 

 

招聘部门：质量控制部（无锡）

招聘岗位：蛋白分析研究员（bioassay方向）

岗位职责：

·  Plan and execute experiments with minimalsupervision, with focus on cell-based assays.

·  Communicate with supervisor and collaborate withcoworkers in developing research methods, data analysis, routine testing andtroubleshooting.  

·  Analyze experimental data independently with highquality, efficiency and productivity with cGMP compliance;

·  Play active roles in preparing scientific writingand GMP documents (e.g. SOPs, transfer reports, assay evaluation/developmentand qualification reports).

职位要求：

·  M.S. or Ph.D. in pharmaceutical, biology or arelated field. Prior experience with antibody, ADC and fusion protein analysisis preferred.

·  Broad knowledge in biochemistry and bio-pharmacy.

·  Prior hands-on experiences in cell-based assays are required.Experiences in other ELISA assays desirable.

·  Highly motivated to embrace new technologies andtools.

·  Good communication skills and team work spirits.

·  Fluent in reading, writing and speaking English.

 

 

招聘部门：质量控制部（无锡）

招聘岗位：蛋白分析研究员（Enzyme activity方向）

岗位职责：

·  Plan and execute experiments with minimalsupervision.

·  Communicate with supervisor and collaborate withcoworkers in developing research methods, data analysis, routine testing andtroubleshooting.  

·  Analyze experimental data independently with highquality, efficiency and productivity with cGMP compliance;

·  Play active roles in preparing scientific writingand GMP documents (e.g. SOPs, transfer reports, assay evaluation/developmentand qualification reports).

职位要求：

·  M.S. or Ph.D. in pharmaceutical, biology or arelated field. Prior experience with antibody, ADC and fusion protein analysisis preferred.

·  Broad knowledge in biochemistry and bio-pharmacy.

·  Prior hands-on experiences in enzyme activity assays,binding potency assays or other ELISA experiments are desirable.

·  Highly motivated to embrace new technologies andtools.

·  Good communication skills and team work spirits.

·  Fluent in reading, writing and speaking English.

 

 

招聘部门：Operations（无锡）

招聘岗位：实验室信息技术经理

岗位职责：

·  Visibly supports and promotes WuXi Biologicsworkplace safety, IP protection and company culture of Positive Energy

·  Provides technical expertise in support of Wuxi GMPmanufacturing and QC analytic service that runs on single computer or networkedcomputer system, and supports comprehensive data acquisition, data processingand data management system. 

·  Supports computer system life cycle management inaccordance with GMP data integrity requirement and established site SOPs

·  Takes parts in data integrity task force, and supportsCSV validation from plan to detailed test scripts, supports internal andexternal audit

·  Acts as Windows system expert, providing technicalsupport in access control, security management, account management and audittrail management

·  Provides technical support in data backup, archive,system upgrade and data migration

·  Assists in installation, operation, maintenance, andtroubleshooting of computers, displays and software applications

·  Assists in information (application) systems design,development, information technology architecture, IT planning, and statisticalanalysis support with ultimate goal of achieving information pyramid from datato knowledge to wisdom

·  Troubleshoots problems, documents and recommends thesolution to that problem

·  Interfaces with corporate IT to coordinate site project,manage and report progress; follows and implements corporate global polices

·  Trains system administrators, end users for dailyoperation and grows internal technique support team

职位要求：

·  Bachelor’s degree in Computer Science or relateddiscipline is required with a minimum of 10 years of relevant experience inservice IT with roles in development, planning and management

·  Minimum of 5 years experience with pharmaceuticalinformation system & technology. Familiar with LIMS, Empower, Scientificdata management system (ECM or Nugenesis), DCS system, or other lab dataacquisition system

·  A broad range of experience across the generalareas; IT infrastructure and installation, and IT operations and maintenance

·  Must have strong customer service, coordination andinterpersonal skills

·  Track records of leading IT integration, systemdeployment, work flow improvement, customized solution project in support ofchemical /pharmaceutical/biologics data efficiency and compliance  

·  General knowledge of regulatory requirements oncomputerized system and ERES, such as 21 CFR part 11

·  Excellent interpersonal, communication, analytical,problem solving, troubleshooting and organizational skills

·  Self-motivated，quickpaced with flexibility of working overtime to meet aggressive timeline

·  Good time management skill, resource planning

·  Good English in both reading and writing. Basiclevel in spoken English

 

招聘部门：质量保证部（无锡）

招聘岗位：Quality System specialist

岗位职责：

· 负责QA相关的SOP的编制、修订和审核;

· 负责管理公司所有纸质与电子版本GMP文件，并监督质量文件在各部门的执行；

· 1）发放新文件编号及文件的变更单号；

· 2）接收及保存已签批的电子版本及纸质版本文件,维护GMP文件的模版；

· 3）负责安排文件生效，并邮件通知相关部门；

· 4）负责受控文件的发放、回收及销毁

· 5）更新文件目录

· 6）负责文件的定期审核，跟踪文件再审核的状态；

· 7）负责制作及控制表格/记录本；

· 8）批记录的控制与分发；

· 9）负责实验记录本的使用及管理

· 负责定期质量回顾工作，并建立相关程序，定期召开质量委员会会议，并跟踪与总结；    

· 负责更新与维护现有质量体系， GMP 法规，系统的不断改进与一致性

· 参与CorporateWuxi Bio的质量体系建立，并制定质量计划，实施与跟踪；

· 协助更新与维护偏差、变更、CAPA体系；

· 协助建立与维护公司应急响应程序；

· 协助审计组，担任QA审计协调员

· 1)   准备受检部门关键联系人员列表

· 2)   协调安排审计过程中前场和后场涉及的人员及文件

职位要求：

· 本科及以上学历，生物学、生物化学、药学等相关专业；

· 5年以上药品或生物制药QA的工作经验，参与质量体系建立及管理经验者优先；

· 熟悉欧盟、中国及美国GMP法规及ICH指南中质量管理相关要求；

· 熟悉ICHQ10药品质量体系的相关要求；

· 良好的英语听说读写能力熟练的使用计算机办公软件；

· 有较强的分析问题及执行能力，具备良好的沟通技巧、工作认真、细致，拥有良好的团队合作精神。

 

 

招聘部门：质量保证部（无锡）

招聘岗位：QC On-line QA Specialist

岗位职责：

· 负责QC的日常监控；

· 负责实验室管理类SOP的审核；

· 协助EM的超警戒限/合格限的处理及跟踪；

· 为QC相关的偏差、变更、OOS/OOT的处理提供技术支持；

· 配合自检及审计工作；

职位要求：

· 药学或相关专业本科以上学历；

· 了解欧盟GMP，cGMP法规及ICH，验证方面指导文件；

· 具备生产或检验相关工作经验；

· 良好的沟通协调能力；

· 良好的计算办公技能；

· 良好的英文读写能力。

 

招聘部门：质量保证部（无锡）

招聘岗位：MFG On-line QA Specialist

岗位职责：

· 负责上游细胞培养和下游蛋白分离纯化（USP&DSP）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；；

职位要求：

· 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。

 

招聘部门：质量保证部（无锡）

招聘岗位：QA Engineer

岗位职责：

·  Oversight the qualification & validationactivities in MFG2.

·  Work closely with qualification & validationteam, Engineering department and other functional department to assure GMPcompliance

·  Support MFG2 project timelines by on time review andrelease of validation/qualification reports according to site SOPs and otherapplicable regulations.

·  Successful coordination of risk analysis and othervalidation related activities for all GxP systems and ensure the risk migrationactions been fulfilled.

·  Successful maintain the validated status of MFG2 forall utility & facility and GxP equipment.

·  Train subordinate to fulfill department growthneeds.

·  Create/Coordinate the periodic review plan accordingto site SOP requirements and implement accordingly.

·  Work closely with QA management and otherprofessionals to ensure high standards quality system. Proactively supporteffective communications with external stakeholders.

职位要求：

·  Ability to collaborate and beculturally sensitive and diplomatic

·  Ability in planning, organization of qualification/validationactivities

·  Ability to work independently and flexible

·  Good knowledge of GxP regulations and practices (e.g.EU-GMP Guideline, Annex 11, CFDA, ISPE guides, etc.)

·  Experience in authority inspections and companyaudits.

·  Experience in clean utility/cleanroom/HVAC andpharmaceutical process equipment.

·  Minimum 3 years working in the pharmaceuticalindustry, multinational company experience is a plus.

·  Knowledge and experience of  Biotechnical processes is a plus:

Ø  Upstream (mammalian cell culture or microbialcultures)

Ø  Downstream (Centrifugation, Cross Flow Filtration,Chromatography)

Ø  Aseptic Filling

Ø  Cell bank and Inoculum Design and operation

·  Experienced in product transfer projects e.g.development =>  manufacturing is aplus.

· Capability ofoperation skills for various testing instruments (Validator, particle counter,etc.) is a plus.

·  Good communication skills, persistence, commitment

·  Rapid learning ability, high level of energy andself-motivation

·  Dispute resolution and decision making skills teamplayer

·  Organized analytical thinker attention to detail

·  Inter-cultural competence, be culturally sensitiveand diplomatic

·  Skilful in using office application software(MS-Word, MS-Excel, MS-Project, MS Power Point, MS-Outlook) .