cmc VP /cto

面议

海外国家

刷新时间：2023-09-08

职位描述

Responsibilities

• Provide strategic leadership and direction to the manufacturing, process development, and supply chain teams.

• Collaborate with Quality and Regulatory Affairs teams to develop, refine and ensure compliance with GMP regulations and standards.

• Maintains up-to-date knowledge of best manufacturing practices and regulatory guidance and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation

• Oversee all manufacturing operations.

• Drive effective decision-making while proactively identifying potential risks to GMP timelines and deliverables; communicate/implement effective risk mitigation strategies.

• Hire, develop, and retain top talent in the manufacturing, process development, and supply chain teams.

• Prepare and manage CMC submissions for all US and global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents

Qualifications

• Ph.D. in Chemistry, Biological Sciences, Engineering or related discipline, with 15+ years of experience. At least 10 years in a leadership role.

• Hands on experience in oversight and management of CMC activities and thorough knowledge of GMP requirements.

• Willing to work side-by-side, roll up your sleeves, and jump right in.

• Previous cell therapy experience is a must.

• Expert knowledge of GMP and FDA regulatory requirements applicable to Biologics including Cell therapy products.

• Ability to lead and influence cross functional employees to ensure compliance.

• Strong knowledge of current industry trends and ability to use the latest technologies

其他要求

招聘人数：1人
职能类别：研发总监/研究院院长

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。