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岗位名称: Quality Assurance Lead

汇报岗位: Executive Director, GCP Quality Assurance

部门:QA, RA, and GA

工作地点:Beijing

岗位概述
Manage and contribute the GCP and GLP and GVP Quality Assurance activities:
Develop/improve and contribute quality systems and processes.

工作职责

  • Conducting routine and for cause audit of investigator site, vendors, internal audits, etc.
  • Manage and review of quality issues
  • Creation/revision of appropriate SOPs
  • Supporting the activities related to the vendor management process training, SOPs, etc.
  • Conducting routine and for cause audit of investigator site, vendors, internal audits, etc.
  • Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
  • Coordinate and/or administer GCP training, as needed
  • Participate and represent Clinical Quality in meetings and discussions as needed
  • Participate in the review of study related metrics (i.e; protocol deviation, etc.) as part of Quality
  • Management Risk approach to identify gaps, trends and the need for process improvements.
  • Manage the inspection readiness activities and lead regulatory health authority inspections.
  • Other duties as assigned

相关工作经验要求

  • Have 5 years GCP audit experience, quality control and clinical research associate experiences.
  • MNC working experience is preferred.

必要的学历和专业资格,含语言能力

  • Bachelor’s degree in biological sciences, medicine or pharmacology (or an equivalent mix of education and experience)
  • Excellent computer skills, including Excel, Word, etc.
  • Thorough knowledge of applicable GCP and GXP regulations, guidelines, policies, and procedures will be preferred.
  • Excellent verbal and written communication skills both in English and Chinese will be preferred.

必要的技能和能力

  • Thoroughly knowledge of GCP. Familiar with GVP or GLP is preferred

投递简历请发送至hr@overlandpharma.com

岗位名称: HR Intern

汇报岗位: HR Manager

部门:HR & Admin

工作地点:Shanghai

岗位概述
支持HR团队日常工作

工作职责

  • 协助HR团队的日常招聘工作:包括简历筛选、面试邀约,实习生招聘
  • 协助招聘数据和人才地图的整理分析
  • 协助支持HR系统数据整理和维护
  • 其他团队支持工作

相关工作经验要求

  • 有相关行业或者实习工作经验优先

必要的学历和专业资格,含语言能力

  • 本科以上,生命科学、人力资源等相关专业,或对人力资源行业有兴趣的在校学生

必要的技能和能力

  • 熟练操作MS office软件
  • 做事认真仔细,有高度的责任感

投递简历请发送至hr@overlandpharma.com

岗位名称: CMC RA Lead

汇报岗位: CEO

部门:Regulatory Affairs

工作地点:Shanghai

岗位概述
Provide regulatory CMC assessments and supports to BD projects, IND strategy and BLA filing.

工作职责

  • Provide regulatory CMC assessment in terms of CMC challenge and potential impacts on the development timeline for BD Projects
  • Provide regulatory CMC supports on the China IND strategy, identify potential gaps btw CDE requirements and available data, establish CMC development strategy in early phase and IND submission timeline
  • Provide regulatory CMC supports during China development process and ensure timely CN BLA or NDA filing and approval via establishing and implementing the CMC development strategy and plan
  • Provide regulatory CMC supports to research projects to ensure clear CMC research strategy in place

相关工作经验要求

  • 5+ years Biology R&D works
  • 3+years Regulatory CMC works in MNC or Bio-pharm or Biotech
  • 1+ year CDE work experience preferred

必要的学历和专业资格,含语言能力

  • Biology Education background, PhD is preferred

必要的技能和能力

  • Strong Biology background
  • Strong communication skill
  • Fluent English skill in both speaking and writing
  • Experience in cross-functional collaboration
  • Strong regulatory sense and expertise in biologic CMC

投递简历请发送至hr@overlandpharma.com

岗位名称: 生产工程师

汇报岗位: 生产经理

部门:生产部

工作地点:上海临港新片区

岗位概述
按照指令和工艺要求完成细胞疗法产品生产;参与生产设备和工艺相关的验证活动;对生产相关SOP进行撰写和修订。

工作职责

  • 按照相应的工艺进行CAR-T细胞制备相关工作,保证产品质量
  • 严格执行生产相关的各种SOP,按要求填写相应记录
  • 负责生产设备的日常维护和保养,保证设备处于良好的运行状态
  • 根据需要接受公司的各类培训,并完成考核
  • 维护生产区域洁净环境
  • 参与公司的工艺转移,参与工艺优化、验证和评估,并执行相关方案
  • 参与生产过程中发生的偏差、变更等

相关工作经验要求

  • 从事生物制药工作2年以上,GMP车间工作1年以上。

必要的学历和专业资格,含语言能力

  • 生物工程、药学等相关专业。
  • 大专或大专以上文化程度。
  • 熟练使用办公软件及电脑操作。

必要的技能和能力

  • 了解药品生产质量管理规范和药品管理法等相关法律法规。

投递简历请发送至hr@overlandpharma.com

岗位名称: QC分析员

汇报岗位: QC经理

部门:QC

工作地点:上海临港新片区

岗位概述
按照SOP和GMP要求,进行相关QC检测分析、偏差跟踪和变更等工作。

工作职责

  • 按照SOP、质量标准和分析方法等,对来料、成品、环境、公共系统进行微生物检测,及时并合适的对各相关活动进行记录
  • 确保GMP相关培训、质量体系培训、岗位培训及其它培训按时完成,严格按照批准的程序要求进行操作,严格按照数据可靠性和良好记录填写规范进行记录填写
  • 记录分析过程中出现的偏差和OOS/OOT,及时报告给直线经理,按照指导进行调查,并追踪调查的关闭和CAPA的执行
  • 参与QC实验室变更、风险评估的管理,以确保符合合规及业务要求
  • 按照已批准的方案,执行方法验证相关的实验,记录原始数据并准备方法验证报告
  • 按照稳定性实验方案进行稳定性研究
  • 实施分析设备的验证和实验室相关计算机化系统验证;支持清洁验证规程
  • 按照SOP要求采购、接收、管理实验室使用的试剂、培养基和菌株
  • 实验室文件管理
  • 严格遵守法规、程序的要求,同时按照GMP常识进行操作,时刻满足数据完整性的要求。及时指出任何违反合规性的操作和事件,并及时向上级经理汇报

相关工作经验要求

  • 3-5年制药公司的经验
  • 熟悉药典,如中国药典、欧洲药典和美国药典等。熟悉GMP。

必要的学历和专业资格,含语言能力

  • 药学、生物化学或微生物学相关专业,本科学历或以上
  • 生物/微生物/药学/化学等相关专业背景
  • 英语读写熟练

必要的技能和能力

  • 良好的团队合作精神
  • 优秀的交流,问题处理,计划和组织能力

投递简历请发送至hr@overlandpharma.com

岗位名称: Medical Advisor (Manager)

汇报岗位: Head of Medical Affairs

部门:Medical Affairs

工作地点:Shanghai / Chengdu / Wuhan

岗位概述
Understand recent progress of product/competitor and relevant therapeutic areas; collect, process, integrate, formulate and share with cross-functional team on insights from HCPs, literature review, congress update and competitor activities; develop medical strategy and medical projects; in charge of developing clinical study protocol as well as authoring/reviewing study report and publication plan; participate in or determine the theme and content of activities including hospital lectures, advisory board, expert discussion and medical education; communicating and cooperating with internal and external customers; provide expert review of training, promotional and project-based activity materials presented by Marketing/Sales department from a scientific viewpoint; provide product related support to Marketing/Sales and other departments.

工作职责

  • Understand recent progress of product/competitor, HCP perception, literature and congress update in relevant therapeutic areas; generate insights from the above resources, then process, integrate and share with cross-functional team.
  • Lead formulation and execution of medical strategy
    • Responsible for productive engagement alone or in cross-functional teams with key national external stakeholders including KOLs but also paying attention to pharmacists, nurses, hospital administrators, government officials etc.as business needs require.
    • Responsible for exhaustive collection of information regarding existing knowledge gaps, scientific data gaps and clinical care gaps.
    • Responsible for authoring the Medical Strategy after collection of input and insights from a wide cross-section of internal and external stakeholders.
    • Responsible for provision of careful, thoughtful input into the review of promotional or educational material that is disseminated to or presented by the company to external audiences.
    • Directing medical strategy and developing medical projects
  • Clinical Study
    • Design and compose clinical study protocols; manage the study budget and phasing; submit protocol for internal review and approval; ensure the registry of the study on line; present at investigator meeting if necessary
    • Set plan for CSR and publication; review study report; carry out medical monitoring during the clinical study
    • GCO/CRO collaborations on ICF and trial operation
    • Collaborate with Statistician and Data Management team for CRF and SAP
  • Determine the theme and content of national activities including advisory board, expert discussion, and contribute to the theme of medical educational materials and hospital lectures. Closely work with Medical Experts when necessary
  • Communicate and cooperate with internal and external customers including JV partners
  • Expert review of training, promotional and project-based activity materials presented by Marketing/Sales department from a scientific viewpoint
  • Provide product and TA related support to Marketing/Sales and other department

相关工作经验要求

  • 2-3 years clinical working experience on relevant therapeutic area/or 2-3 years working experience on pharmaceutical industry is preferred.

必要的学历和专业资格,含语言能力

  • Clinical medicine / Pharma background
  • Master or above, MD/Ph.D/Pharma D is perferred
  • Fluent spoken & written English

必要的技能和能力

  • Thorough understanding and command of product and relevant therapeutic area knowledge.
  • Thorough understanding and command of GCP.
  • Thorough understanding and command of compliance.
  • Good marketing sense and creative thinking; good communication and learning agility.
  • Good command of English, fluent at reading, writing, speaking and listening.
  • Effective execution of medical strategies and projects.
  • Quality of clinical study design and insight collection, processing and sharing.
  • Publication (quality and quantity) in peer review scientific journal.
  • Profound knowledge of the TA disease and product.
  • Business acumen.
  • Cross functional collaboration.
  • Through engagement of national KOLs, clearly identify the scientific data gaps, knowledge gaps, and clinical care gaps.

投递简历请发送至hr@overlandpharma.com

简历请发送至:hr@overlandpharma.com