药化

40-70万元/年

市辖区

刷新时间：2024-02-27

职位描述

  Responsibilities

 • Critically review data from contract partners, provide timely feedback to secure
prompt resolution of technical and quality findings. • Work effectively in cross-functional teams and support the team objectives in
delivering project milestones.
• Work closely with CMOs and CROs to ensure timely release of manufactured
drug substances and drug products.
• Draft or review pharmaceutical development reports, relevant sections of CMC
documentations in support of INDs, IMPDs and NDAs submissions.
• Responsible to use science driven and QbD and risk management-based
approach to develop robust API and drug product manufacturing processes.
• Responsible for API manufacturing and drug product manufacturing process
development, scale-up and the manufacturing to enable project advancement
from preclinical to clinical and from clinical to commercialization.
• Critically review data from contract partners, provide timely feedback to secure
prompt resolution of technical and quality findings.
• Work effectively in cross-functional teams and support the team objectives in
delivering project milestones.
• Work closely with CMOs and CROs to ensure timely release of manufactured
APIs and drug products.
• Author and review pharmaceutical development reports, relevant sections of
CMC documentations in support of INDs, IMPDs and NDAs submissions.   

• Establish SOPs and workflows and find creative ways to resolve problems.
• Compiles and reports pharmaceutical development status to study teams and
senior management.
• Assists in designing and continuously improving Quality Control systems,
processes and procedures.
• Assists with developing and validating testing methodology.

其他要求

招聘人数：3人
汇报对象：Senior Director of Pharmaceutical Development
职能类别：药物分析/药品检验

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。