天津招聘

职位描述：
Job Major Accountabilities岗位主要职责
?Participate the routine QC work including sampling, in-process control, finished product release.
?Perform the execution of method validation project.
?Support the R&D and stability sample testing
?Responsibility for daily maintenance of lab equipment and environment
?Handle routine quality system investigation procedure in operation process such as OOS, Deviation, and CAPA.
?Draft the Lab documents such as SOP, Protocol, validation reports.
?Strictly follow the SOPs and EHS rule of company
?Other task as assigned by superior

 Basic Requirements主要任职条件
?College degree or above. Majored in medicine analysis or related
?Basic knowledge of pH, UV, IEF, SDS-PAGE, etc.
?The experience of GMP environment or pharmaceutical company is preferred
?Good communication, cooperation and organization skills
?Computer Literate MS Office to include Excel and Word
?Working as part of a team or alone/remotely

CORE COMPETENCE 核心竞争力
?Knowledge in medicine analysis or Pharmaceutical laboratory and industry experience
?Teamwork spirit and Self-motivated
?Good communication and trouble shooting

Major Contacts(Outside Organization) 主要接触对象 (公司以外)
Internal: Quality Assurance, Engineering , Manufacture, Purchase, Logistic
External: Vendor


CRITICAL SUCCESS FACTORS关键考核/成功指标：
?The quantity and quality of QC bench work
?The quantity and quality of documentation 举报 分享

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。