CMC

面议

江苏省

刷新时间：2023-01-13

职位描述

Job Responsibility
• As the CMC leader of assigned projects for the company, provide technical leadership to steer the CMC activities en route to successful IND filing and/or late stage development and BLA submission to regulatory agencies such as US FDA, EMA, NMPA, WHO, etc.
• Participate and show leadership in establishing WuXi Biologics CMC strategies and recommendations to support all ongoing projects in CMC development.
• Lead CMC projects with good understanding of potential technical challenges and meeting the regulatory requirements and ICH guidelines.
• Collaborate with CMC functional areas to ensure successful execution of various CMC strategies, on-time delivery of results and staying within budget.
• Chart the course, track progress against goals and outline key strategic events for project. Manage project scope definitions and changes, and budgets.
• Serve as the center of solution for technical issues. Address any challenges and issues that arise. Make hard decisions if needed.
• Engage effectively with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.
• Build a solid communication with ****** to ensure alignment between WuXi Biologics and ******s.
• Provide leadership in development and manufacturing alliance management, product development and manufacturing strategy
• Support BD efforts and proposal writing team to enhance current service offering and develop new ******s.

Opportunities
• Broaden and deepen understanding and experience in biologics development
• Gain cross-functional knowledge in real life biologics development and CMC management
• Develop leadership skill
• Enhance personal well-roundedness in preparation for executive capacity

Required Qualifications
• Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Sciences or related major with 10-15 years of applicable work experience. Exceptional candidates with 5-10 years of relevant working experience will also be considered.
• Proven track record of expertise in any areas of biologics CMC development (e.g., CLD, bioprocess, analytical, formulation, manufacturing science, etc.), good understanding of overall CMC strategy, risk and resource management, regulatory requirements and ICH guidelines.
• Demonstrated strategic decision-making abilities as well as problem-solving skills.
• Excellent verbal and written communication skills in both English and Chinese.
• Ability to work effectively across functions, teams and stakeholders.
• Excited at the vision and mission of WuXi Biologics, and embracing WuXi Biologics PROUD culture

Preferred Qualifications (Not Required)
• Experience in formulation and/or drug product development highly desirable.
• Previous working experience at or with CDMO a plus.
• Basic level in Korean, Japanese, Cantonese or other languages will be a plus.
• Experience in writing regulatory documents and submissions a plus

其他要求

招聘人数：1人
职能类别：CMC

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。