南京招聘

The position of MS Engineer/Sr. Engineer is responsible for parenteral drug product sterile process technology. Provide supporting to process, deviation investigations, change controls, CAPAs, and quality improvements).
1.Provide technical and scientific support on aseptic processing and fill-finish activities for clinical and commercial manufacturing including technology transfer, technical troubleshooting, and continuous improvement of sterility assurance and process.
2. Familiar with sterile technology，deeply understanding on aseptic behaviour and sterile process and control strategy.
3. Lead/perform gap analysis and risk assessment & mitigation plan during drug product technology transfer and manufacturing.
4. Work with cross functional team to develop site sterility assurance strategies and maintain validated status.
5. Prepare and deliver technical reports, documents for regulatory submissions
6. Draft and review dossiers for IND/NDA filing and other regulatory related documents as needed.
7. Support new Drug Product facility and production line start up.
8. Deviation handling and change control driver.
9. Involved in audit/inspection preparation and observation follow up.

Qualifications:
1. MSc or BSc in Microbiology, Chemical Engineering, Biochemical Engineering or equivalent with minimum of 5+ year relevant experience in parenteral formulation/fill/finish clinical and commercial manufacturing.
2. Having experience in aseptic process operation or quality assurance in the field of biopharmaceutical under NMPA, EMA and FDA GMP regulations.
3. Having high compliance and aseptic mindset. Be familiar with risk assessment tool, such as FEMA, etc.
4. Technical Transfer experience.
5. Performance qualification, process performance qualification and media fill.
6. Good logical thinking and communication with skills of both English and Mandarin (written and spoken)
7. Well team work initiatively.
8. Goal-oriented and adaptable, with the ability to model a corporate culture that emphasizes Quality, Speed, and Innovation

    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。