制剂高级工程师

20-50万元/年

广东省

刷新时间：2天前

职位描述

核心职责

Responsible for preformulation, formulation and process development of OINDPs.

Troubleshoot and problem-solve unresolved or new formula issues.

Design and execute formulation trials, analytical testing and evaluate stability data to finalize formulation composition.

Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.

Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.

Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product and Process Development Reports, etc.

Make scientific presentations to internal and external teams as well as external industry meetings

Prepare/review specifications for drug products and packaging components, etc.

Be responsible for the manufacturing of exhibit/submission batches per regulatory requirements.

Be in charge of technology transfer for manufacturing processes from laboratory scale to production scale.

Work with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Operations, etc. to expedite the development and approval of new products by cFDA.

Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs.

Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.

Actively participate in obtaining patents for products, processes, or equipment. Communicate with outside vendors and laboratories.

Provide technical assistance/support for other departments as needed.

Communicate essential information to the employees within the department and/ or within the company.

知识技能

Thorough knowledge of the pharmaceutical industry, particularly drug delivery industry, and formulation and process development.

Knowledge of GMP regulations.

工作经验

MSc or PHD in pharmaceutical and related fields, with at least 3 years of related work experience

核心能力

制剂开发能力

组织协调能力

个性特质

严谨

专研精神

素养要求

自驱、有爱心、有自省

价值观

创新、在一起、一切为了梦想

其他要求

招聘人数：1人
职能类别：其他质量职位

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。