天津招聘

We are seeking a highly motivated individual with a strong background in immunogenicity assessment to support pre-clinical and clinical studies. In a rapid-growing biotech company, you will lead a team for immunogenicity assay development, validation, and applicable sample analysis within Bioanalytical Sciences department of Global R&D. You will play a critical role in development of biological therapeutics from early research, IND enabling GLP studies, clinical trials through NDA/BLA/MAA submission and post-marketing pharmacovigilance immunogenicity testing support.

Responsibilities
? Build and manage a bioanalytical team to support regulated immunogenicity assessment in house.
? Coach and lead scientists and associate scientists for anti-drug antibody assay and neutralizing antibody assay establishment to support pre-clinical and clinical studies.
? Provide technical expertise, strategies and make decisions for immunogenicity assessment.
? Review clinical study protocols, reports and regulatory submission documents.
? Write regulatory submission document including method validation reports, sample analysis reports, and integrated immunogenicity assessment reports.
? Interact with PK/PD and Operational teams within the department as well as outside groups to represent Bioanalytical Sciences department in project teams.
? Oversee outsourced works to ensure delivery of highest quality data within timeline and budget.
? Lead compliance effort for applicable bioanalytical activities.

Qualifications
The candidate should have proven scientific background with MS or PhD degree in Immunology or a relevant scientific field with a minimum of 3 years (for PhD) and 6 years (for MS) of relevant industry experience and a minimum of 2 years of people management experience in a managerial role. Candidate must have in-depth understanding and hands-on expertise of immunogenicity assay platforms applicable in preclinical and clinical development. Extensive experience with using Watson LIMS system immune response module is required. Knowledge of regulatory guidance and experience in preparing regulatory documents is also required. Good knowledge of automation system is a plus. The candidate must have strong leadership, project management experience and excellent oral and written communication skills.

    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。