天津招聘

CMC Project Lead
Job description
POSITION SUMMARY
This is an exciting opportunity for motivated individual to enrich and broaden his/her biopharmaceutical development experience for both career advancement, and at the same time, making meaningful impact to patient lives in one of the highly regarded and fast growing biotech companies in China.
This CMC Project Lead and Manager, working with the CMC team members, is responsible for product CMC strategy, planning and execution by leading and managing a CMC team consisting of technical representatives. He/she will support two or more biologics projects in all CMC aspects of product development from clinical Phase I to commercialization. The CMC Project Lead will focus on the CMC strategic and operational aspects of the program while also supporting the team in making complex cross-functional decisions (e.g., scenario planning, risk assessment, setting strategic priorities). This role will report to the VP, CMC Operations.
Responsibilities
The primary responsibility will be leading and managing project CMC team, ensuring that project priorities and plans are developed and executed in accordance with corporate goals.
？Identification, planning, and execution of key program CMC initiatives and milestones to support corporate goals.
？Lead the project CMC team in making complex cross-functional recommendations / decisions
？Lead and manage team meetings and agenda topics, facilitate discussions, propose/recommend key decisions, and follow up with action items.
？Ensure alignment of objectives, plans, and activities across various CMC functions (e.g., R&D, Process Development, Analytical Chemistry, QC, QA, Manufacturing, Regulatory Affairs, Supply Chain, etc.).
？Familiar with operational aspects of the program and produce documents and visual tools to facilitate project tracking and progress (e.g., decision and action logs, planning trackers, timelines, etc.).
？Develop and maintain strong, collaborative relationships with key stakeholders
？Ensure that timely and consistent communications regarding program strategy, status and decisions are made within the team and to other stakeholders, including senior management.



Qualifications
Education: a Bachelor of Science in scientific fields (e.g. Biology, Chemistry, Engineering, or Pharmacy) required. Advanced degree (Masters or PhD in a scientific discipline) is preferred but not required. Professional training/experience in project management is a plus.
8+ years’ experience in a Biotech or Pharmaceutical organization in drug development with expertise/knowledge in such functions as Process Development, Manufacturing and Engineering, Quality, Analytical Chemistry, Formulation, Supply Chain, Regulatory Affairs
Self-motivated, and eager to learn; strong ownership, and ability to follow through with direction/tasks; proactive and positive when facing challenges
Comfortable working in a team environment, and can motivate and help others to achieve CMC goals with team efforts
High degree of professionalism, respectful to others and ability to work in fast-paced and dynamic environment
Working knowledge of overall drug/biologics development process and familiar with various functional areas and their roles within a biotech / pharmaceutical company.
Prior experience in supporting pre-clinical and/or clinical-stage drug development programs, preferably across different phases (e.g. Phases I–III).
Some knowledge of cGMP is desirable
Excellent collaboration, oral and written communications, influence skills and sound judgment
Ability to communicate to both broader organization and the senior management
Ability to multi-task and shift priorities quickly while working under tight deadlines; ability to work under uncertainty
Attention to detail, highly organizational, and willingness to learn quickly
Good skills in common word processing tools (such as Words, PowerPoint, Excel, and MS Project)
Title will commensurate with individual’s experience and qualifications

    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。