天津招聘

Job Description and Responsibilities：
The position of MS Engineer/Sr. Engineer is responsible for internal & external technology transfers, manufacturing support (on line support to Phase III and commercial manufacturing, deviation investigations, change controls, CAPAs, and quality improvements), process validation and NDA/BLA filing. This position will also provide advice and guidance on manufacturing technology issues, manufacturing capacity strategy, process scale up strategy, new facilities designing, and continuous improvement.
？ Lead/participate the antibodies downstream purification technology transfer including the transfer from internal development department to GMP commercial sites, from commercial site to another commercial site and to external CMO sites.
？ Lead/perform downstream Risk Assessment & Mitigation during technology transfer and manufacturing.
？ Function as a downstream Subject Matter Expert, provide on-the-floor and on-site technical support, and perform process monitoring, deviation investigation, troubleshoot investigation-driven events, and problem solving.
？ Develop and review process specification, process control strategies, master batch records and SOPs, in process sampling plans, change controls, deviation impact assessments, validation strategy, PPQ protocols and regulatory filings.
？ Develop at scale resin/membrane reuse strategy and validation protocol, continued monitoring any analysis to support product release.
？ Support NDA/BLA dossier (manufacture section) preparation, Support PAI (Pre-approval Inspection) and GMP audits.
？ Establish/utilize lab scale down model to support deviation investigation, change control evaluation, new material qualification, re-filtration studies and post-launch process optimization.
？ Product trend analysis for commercial products and process monitoring.
？ Oversight CMOs routine production activities and provide technical support.
？ Support new facility design, process equipment selection and new facility start up.
？ Liaise with different commercial sites and clinical manufacturing groups to implement best practices.
？ Network with other companies and industrial organization for benchmarking new manufacturing technologies


Qualifications:
？ MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 5+ year relevant experience in biologics process development or commercial manufacturing.
？ Having experience recombinant protein/antibody large scale manufacturing or process development.
？ Skilled in chromatography or membrane filtration or virus clearance technology.
？ Experience in GMP production in the field of biopharmaceutical under NMPA, EMA and FDA GMP regulation
？ Good communication skills of both English and Mandarin (written and spoken)
？ Goal-oriented and adaptable, with the ability to model a corporate culture that emphasizes Quality, Speed, and Innovation
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    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。