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简历请发到 hr@edigene.com,标题注明:“应聘『职位』+名字”,并附带一封求职信

以下是我们开放申请的职位(点击标题查看职位介绍)

Responsibilities:

• Serves as expert in cell processing technology development for manufacture of cell therapies within a GMP manufacturing environment.

• Establishes project plans and timelines for process development, process technology transfer and GMP manufacturing start-up for multiple stem cell therapy development projects, and manage activities through to punctually achieving goals. 

• Provides technical and GMP guidance to members of the teams across process development, manufacturing and validation disciplines.

• Represents manufacturing and clinical manufacturing functions for authoring, reviewing and approval of GMP documents.

• Represents process development and clinical manufacturing functions in cross-functional team forums.

• Authors and assembles CMC sections of regulatory filing including INDs and amendments and equivalent documents for filings.

• Leads project sub-teams and working groups.

 

Requirements:

• Degree in a biological science with a minimum of 7 years or more years of relevant experience in biologics development including cell therapy development: PhD (preferred) with 7 or more years of relevant experience; or a MS with 12 or more years of industrial experience, or BS with 16+ years of industrial experience.

• Fundamental knowledge in cell biology, cell culture, cell processing and cell cryopreservation principles.

• Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under GMP, validation, Quality Systems and regulatory requirements.

• Demonstrated in-depth skills in designing, executing and interpreting experiments.

• Experience authoring CMC sections of CMC regulatory documents.

At EdiGene, we are committed to translate the cutting-edge genome editing technologies into novel therapeutics for genetic diseases and cancer, and into creative solutions to advance drug discovery. In August 2018, we closed a pre-B round of 100 Million RMB, led by Lilly Asia Ventures.

 

Within our exciting portfolio, one of the leading programs is Universal CAR-T through proprietary gene-editing technologies and innovative CAR design. We are looking for an experienced and passionate R&D Director to join us to advance this important program.

 

Responsibilities:

· Lead the Universal CAR-T Group to advance the lead program

· Responsible for optimizing and driving Universal CAR-T/ TCR-T strategy

· Partner with external, CAR-T/TCR-T leaders to develop new Universal CAR-T/TCR-T programs

· Develop internal Universal CAR-T pipeline

· Analyze and interpret the data generated during discovery, early and/or late stage R&D.

· Responsible for timely and effective communication of data, strategy and results to the project team and the management.

· Co-author and prepare key preclinical and clinical, and regulatory documents, scientific manuscripts and patent application, including, but not limited to: study protocols, study reports, modeling reports, investigator brochures, INDs within agreed timelines, and meeting all regulatory requirements.

 

Requirements:

• PhD, strong scientific background in immunology and/or oncology.

• Experience with antibody discovery and characterization required

• Experience with in vitro/ in vivo immuno-oncology animal models required

• Experience with virus vector design and optimization desired

• Familiarity with gene-editing technologies a plus

• Extensive knowledge of cell biology and cancer biology, solid scientific publication

• Pharmaceutical industry R&D work experience a plus

• Proficiency in English a plus

Responsibilities:

Data mining of large scale multi-omics data, next-gen-sequencing data in particular.

Integrating multi-omics data for drug discovery and biomarker development.

Developing useful computational tools and new algorithms for biological re-search.

Providing expert data-mining support to drug discovery and translational re-search.

Working in a multi-disciplinary team with lab scientists and IT professionals to support drug discovery.

 

Requirements:

PhD or MS in bioinformatics, computational biology, mathematics, computer science or other related fields.
Languages Business-level oral and written English.

5+ years of relevant post-graduate research experience in bioinformatics data analysis.

Independent problem-solving capability in bioinformatics field.

Excellent skills in statistical software like R.

Excellent skills with programming languages such as Perl and Python.

Working knowledge in statistics

Strong communication and interpersonal skills.

Responsibilities:
• Responsible for development and evaluation process for all BD opportunities worldwide, including in-licensing, out-licensing, collaborations, distribution agreements.

• Responsible for structuring, negotiating and execution of partnerships.

• Establish and maintain excellent relationships with potential partners and key stakeholders.

• Represent companies various partnering and scientific conferences.

Assist company leadership with data and insights to develop business.

Requirements:
• Minimum of 8 years of experience in biopharmaceuticals.

• PhD in biological or pharmaceutical sciences required.
• Exceptional interpersonal, oral and written communication skills in English and Chinese

• Strong presentation skills to deliver recommendations.

• Good understanding of global biologics research, development, regulatory, manufacturing processes and commercialization preferred.
• Experience in business development, licensing, market and competitive analyses, including a broad understanding of the financial, commercial and legal dimensions that support the evaluation process.
• Expected to travel as required to meet business needs.

Responsibilities:

• Support lifecycle management of release methods by evaluating and proposing enhancements to the test methods.

• Support activities related to the transfer and validation of analytical methods from Clinical to Commercial QC, and commercial QC to external testing sites.

• Assist with deviation, investigation, CAPA and change control activities at EdiGene and contract labs, as needed.

• Support inspection readiness activities.

• Develop, revise and review SOPs, protocols and technical reports.

• Participate in generating training module and instruction led training material.

• Responsible for generating trending charts for monitoring method performance, product quality, invalid rate and/or stability.

Requirements:
• PhD with 5+ years or Master with 8+ years of experience in a GMP environment.

• Experience in a number of analytical techniques, including but not limited to, Flow Cytometry, Real Time PCR, ELISA, Cell Viability measurement, etc.

• Experience in performing analytical method validation and supporting method transfer activities.

• Familiarity with FDA, ICH and GMP guidelines.

• Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls.

• Excellent skills in Microsoft Office, data analysis software, and other related applications.

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

l   岗位职责:

l   负责公司知识产权法律保护体系的构建与维护;

l   负责对公司各种对外合同项目的起草,审核、修改、合规建议;

l   为公司的经营管理活动提供法律支持及合规建议,制定、完善公司风险评控管理体系;

l   参与公司合同的谈判和法律文书的审核及复核,组织拟订相关合同文本;

l   协助公司各部门处理、解决运营中发生的各类法律纠纷,维护公司合法权益;

l   负责公司的诉讼和仲裁活动,对公司委托法律服务机构处理的诉讼案件进行审查、跟踪,并提出处理意见,保障公司合法权益。

l    

l   任职要求:

l   本科及以上学历,法律相关专业;

l   具有独立承担工作任务的能力;

l   深厚的法律专业功底;具有丰富的法务管理、纠纷处理工作经验;

l   5年以上法务或律所工作经验,医疗行业经验优先;

l   精通合同法、公司法、电商、知识产权法、劳动法律法规等;

通过国家司法考试,具有律师资格证。

岗位职责:

根据公司业务的发展,负责各操作系统平台的搭建及开发;

根据公司业务需求,负责信息化系统规划与设计开发、业务运行与技术支持管理;

参与制定公司内部网络、计算机软硬件标准化方案及信息安全解决方案,负责公司计算机系统标准化和信息安全实施工作;

参与公司IT相关管理规范、规章制度的建立、执行与监督工作;

负责落实信息技术安全;

领导交办的其他工作。

 

任职要求:

1.计算机、电子通讯等专业本科及以上学历;

2.接受过企业或社会的硬件、软件系统相关培训,有较强的自学能力;

3.8年以上相关工作经验,5年以上企业信息化项目实施经验;

4.丰富的企业信息化建设经验,应用管理信息系统及网站建设项目管理经验;熟悉企业核心业务流程CRM/IPD/ISC/IFS系统建设,成功主导推进过信息化变革大项目经验;具有较强的网络安全意识、较强的信息安全和保密意识;熟悉服务器、存储系统的选型、搭建、配置、监控、性能优化和维护;具有防火墙、入侵防御、VPN等网络安全系统的应用经验;熟悉路由器、入侵防御、VPN等网络安全系统的应用经验;

5.良好的沟通表达能力、组织协调能力和团队合作能力,敬业、热爱团队、责任心强。

l   岗位职责

l   根据现有编制及业务发展战略,分析人力资源需求,制定招聘计划及招聘预算。

l   建立和完善单位的招聘制度、流程和招聘体系。

l   开发、维护、评估、分析各招聘渠道,包含猎头、校园、论坛等。

l   简历甄别、面试、筛选、录用沟通、跟踪管理等工作。

l   建立企业人才库,对招聘相关数据进行统计分析,定期完成人力资源数据报告。

l    

l   任职资格:

l   本科及以上学历,人力资源等相关专业;

l   熟悉招聘流程,熟练运用各种招聘工具和手段;

l   具备丰富的招聘经验及技巧,熟悉国家相关法律法规;

l   具有良好的职业道德和职业操守及良好的团队合作意识;

l   优秀的语言表达及沟通能力。

l   有生物、医药行业从业经验者优先。

l   岗位职责:

l   负责建立并完善公司内部控制体系,组织识别评估公司可能存在的风险,组织公司各部门甄别评估风险,并制定风险应对措施,跟踪整改效果。

l   根据上市公司要求进行财务管理和会计核算工作,保证公司财务工作符合企业上市的条件。

l   负责组织公司的财务核算工作,保证公司财务核算工作准确、及时、完整的反映公司的实际经营成果和财务状况。

l   负责建立资产运营效率指标体系,监控和提高资产运营效率。

l   实施公司的预算管理工作,根据公司实际情况不断优化完善预算管理体系,制定并完善公司预算管理办法及实施细则,组织相关部门进行预算的推进工作,定期对预算进行分析,加强管理、促进各项经济指标的实现;

l   主持核价管理工作和产品定价工作,制定产品定额成本核算标准和产品定价管理制度,保证公司产品既定利润的实现。

l    

l   任职要求:

l   35-40岁之间,大学本科及以上学历,会计或财务管理相关专业;

l   十年以上生产型企业财务工作经验,五年以上财务管理工作经验;

l   精通企业会计准则,有上市公司内控管理经验;

l   具有较强的组织领导能力、执行能力、沟通协调能力;

l   熟悉财务法规及税法政策,有上市公司财务管理经验。

l   岗位职责:

l   协助制定生产需求计划并及时更新。

l   以需求计划为基础,预测未来24个月内的各种相关计划(人、机、料、场地、时间、成本),协调制定满足治疗项目方案。

l   以生产计划为目标协调生产、采购、物流、QCQA及工程的相关资源,完成既定生产目标。

l   与各相关部门保持顺畅的信息沟通渠道,“现场、现时、现物”跟进与反馈生产进度。

l   与物流、生产、QCQA保持信息沟通顺畅,及时获取、提供与反馈产品物流信息,按照单采血/成品回输SOP的既定流程推进,确保各物流环节准确衔接。

l   物料管理、生产计划管理相关主数据的收集维护,并根据实际运行情况提出合理的改进建议。

l    

l   任职要求:

l   全日制本科及以上学历。

l   三年以上供应链或物流相关工作经验,医药或生物制药相关背景,熟悉GMP,在大型药品企业负责计划管理工作者更佳。

l   较强的口头及书面表达能力,较好的分析能力及协调能力。

l   熟练使用ExcelWordPowerpoint,有SAP使用经验者更佳。

l   英语6级及以上,具有良好的听说读写能力。

l   岗位职责:

l   负责公司工程项目施工相关管理工作,保证工程项目顺利竣工。

l   负责部门其它事务的管理

l    

l   任职条件:

l   同岗位工作经验5年以上经验,生物、GMP车间、制药行业工作三年以上;

l   熟悉HVAC系统、水系统、循环冷却水、冷冻水系统、空调自控编程,有相关电气和暖通经验、有药厂经验者优先;

l   水电及建筑相关专业,具备水电及建筑相关专业知识;

l   良好的协调沟通能力、敏锐的信息获取能力;

责任心强、原则性强、组织、管理能力强;

Responsibilities:

• Independently designs biological assays and method control strategies.

• Leads method attribute assessment and scoring to identify critical quality attributes

(CQA) of the method and critical reagents/equipment.

• Develops bioassays to deliver results with appropriate precision and accuracy to meet

manufacturing and QC release needs.

• Leads bioassay method routine testing to support the process sciences organization.

• Deep experience in flow cytometry including research grade (8+ colors) and regulated

(CLIA/QC 4-6 colors).

• Manages timelines for the method lifecycle including development, qualification and

transfer to QC, QC validation, transfer to CTO if required, method changes or remediation,

deviations, CAPA.

• Assesses bioassay method performance in analytical development and reviews method

performance in QC.  Identifies issues and remediates based on company priorities.

• Leads bioassay comparability testing supporting process changes and process transfers.

• Implements appropriate assay controls, and characterizes references standards in bioassays

as required, aligned with the product attributes.

• Authors and reviews bioassay method development reports, drafts bioassay qualification

protocols, mentors analytical and QC staff during co-qualification and reviews qualification

reports, drafts bioassay validation protocols, supports QC during validation and reviews validation

reports. 

• Leads bioassay method transfer.

• Authors/reviews analytical method development, qualification, transfer, and method validation

sections and supports Response to Questions (RTQ).

• Supports annual product reviews related to bioassay performance. 

• Trends bioassay method performance in analytical development and supports method trending

review in QC.

Requirements:

• PhD in cell biology, immunology or related fields, with 4-8 years of industrial experience, or MS

with 8+ years of industrial experience.

• Fundamental knowledge of cell culture and immunology.

• Experience developing, transferring or validating analytical methods into regulated environments (e.g. QC labs).

• Experience with Stem cell manipulations.

• Demonstrated skills in designing, executing and interpreting experiments.

• Demonstrated skills and experience in Design of Experiments and statistical data modeling.

Responsibilities:

Ÿ   Provide general secretarial services to CEO;

Ÿ   To assist CEO manage the internal project related to R&D, Business and Operations;

Ÿ   To assist CEO manage and expand external resource of investing, marketing, academic and scientific R&D;

Ÿ   To manage CEO's agenda and related information and document;

Ÿ   To coordinate CEO's travel needs including itinerary for domestic and international travel;

Ÿ   To assist CEO manage Internal communication and events;

Ÿ   To assist CEO arrange and manage other supporting activities as assigned.

Ÿ    

Requirements: 

Ÿ   Master degree or above, related in business administration/management preferred;

Ÿ   Over 5 years working experience as secretary or assistant to senior management, PR experience is a plus;

Ÿ   Proficient in English (written and Oral), overseas education or working experience is a plus;

Ÿ   Good interface with people, willing and capable to learn;

Ÿ   Experience in the biological and pharmaceutical industries is preferred;

Ÿ   Microsoft Office skills, including Word, Excel and PowerPoint.

At EdiGene, we are committed to translate the cutting-edge genome editing technologies into novel therapeutics for genetic diseases and cancer, and into creative solutions to advance drug discovery. In August 2018, we closed a pre-B round of 100 Million RMB, led by Lilly Asia Ventures.

 

Within our exciting portfolio, one of the leading programs is In Vivo Gene-editing therapy, proprietary gene-editing systems that could be delivered systemically via viruses or lipid nano-particles to target organs in patients. We are looking for an experienced and passionate R&D Director to join us to advance this important program.

 

Responsibilities:

· Lead the In vivo gene-editing therapy group

· Responsible for optimizing and driving in vivo gene-editing strategy, including prioritizing the diseases to target, developing and optimizing delivery vehicles

· Develop internal pipeline

· Analyze and interpret the data generated during discovery, early and/or late stage R&D

· Responsible for timely and effective communication of data, strategy and results to the project team and the management.

· Co-author and prepare key preclinical and clinical, and regulatory documents, scientific manuscripts and patent application, including, but not limited to: study protocols, study reports, modeling reports, investigator brochures, IND/IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.

 

Requirements:

• PhD, strong scientific background in cell biology or molecular biology.

• Experience with in vitro/ in vivo animal models for various diseases required

• Experience with virus vector design and optimization desired

• Experience with genetic diseases a plus

• Familiarity with gene-editing technologies a plus

• Extensive knowledge of cell biology and molecular biology, solid scientific publication

• Pharmaceutical industry R&D work experience a plus

Proficiency in English a plus

At EdiGene, we are committed to translate the cutting-edge genome editing technologies into novel therapeutics for genetic diseases and cancer, and into creative solutions to advance drug discovery. In August 2018, we closed a pre-B round of 100 Million RMB, led by Lilly Asia Ventures.

 

Within our exciting portfolio, one of the leading programs is High Throughput Genome Editing Screening (HTS), using proprietary technologies on top of traditional CRISPR-based genome screening technologies. We are working with leading multinational pharmaceutical companies to apply these technologies to solve critical problems in R&D.  We are looking for an experienced and passionate R&D Associate Director/ Senior Manager to join us to advance this important program.

 

Responsibilities:

· Report to the Head of HTS

· Responsible for optimizing the HTS study design, workflow and data analysis to support drug discovery

· Responsible for adopting cutting-edge genome editing technologies into robust commercial services

· Responsible for providing excellent services to customers and clients

· Work with the team to develop new assays and improve key aspects of HTS

· Analyze and interpret the data generated during discovery, early and/or late stage development.

· Responsible for timely and effective communication of data, strategy and results to the project team and the management.

 

Requirements:

• PhD, strong scientific background in cell biology or molecular biology.

• Experience with high throughput systems and genetic screenings required

• Experience with bioinformatics-based analysis required

• Experience with partnership with multinational companies desired

• Familiarity with gene-editing technologies a plus

• Familiarity with drug discovery process a plus

• Extensive knowledge of cell biology and molecular biology, solid scientific publication

• Pharmaceutical industry R&D work experience a plus

• Proficiency in English a plus

At EdiGene, we are committed to translate the cutting-edge genome editing technologies into novel therapeutics for genetic diseases and cancer, and into creative solutions to advance drug discovery. In August 2018, we closed a pre-B round of 100 Million RMB, led by Lilly Asia Ventures.

 

As our leading programs are progressing toward GMP and clinical testing stages, we are developing assays/methods discovered at the research and discovery stage into robust methodologies according to regulatory guidelines such as ICH and pharmacopeia. These methodologies are then qualified or validated, in order to measure critical parameters in GMP manufacturing (Analytical) and clinical trials (Bioanalytical). We are looking for an experienced and passionate R&D Director to join us to lead these activities.

 

Responsibilities:

• Lead the Analytical Development Group

• Responsible for analytical and bioanalytical development strategy and execution, including prioritizing key assays/methods and developing qualification/validation plans

• Lead method attribute assessment and scoring to identify critical quality attributes of the method and critical reagents/equipment, and develop assays/methods to deliver results with appropriate precision and accuracy to meet manufacturing and QC release needs.

• Manages timelines for the method lifecycle including development, qualification and transfer to QC, QC validation, transfer to CMO if required, method changes or remediation, deviations, CAPA.

• Assesses bioassay method performance in analytical development and reviews method performance in QC.  Identifies issues and remediates based on company priorities.

• Authors and reviews assay/bioassay method development reports, drafts bioassay qualification protocols, mentors analytical and QC staff during co-qualification and reviews qualification reports, drafts bioassay validation protocols, supports QC during validation and reviews validation reports. 

• Supports annual product reviews related to bioassay performance. 

 

Requirements:

• PhD in cell biology, molecular biology, immunology or related fields, with 4-8 years of industrial experience, or MS with 8+ years of industrial experience.

• Experience developing, transferring or validating analytical methods in regulated environments required

• Deep experience in flow cytometry including research grade (8+ colors) and regulated (CLIA/QC 4-6 colors)

• Fundamental knowledge of cell culture and immunology assays

• Experience with Stem cell and primary cell manipulations desired

• Demonstrated skills in designing, executing and interpreting experiments

• Demonstrated skills and experience in Design of Experiments and statistical data modeling

关于我们


公司总部

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广州市南沙区珠江街南江二路6号10栋

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245 FIRST STREET, RIVERVIEW II, 18TH FLOORCAMBRIDGE, MA 02142 USA

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