Manufacturing Director
杰科（天津）生物医药有限公司
- 公司规模：50-150人
- 公司性质：合资
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-02-22
- 工作地点：天津-滨海新区
- 招聘人数：1人
- 工作经验：10年以上经验
- 学历要求：硕士
- 职位月薪：2.5-3万/月
- 职位类别：生物工程/生物制药
职位描述
职位描述：
Responsibilities:
- Work with the technology transfer department to finished the process & engineering amplification and process optimization.
- To be responsible for pilot scale production and clinical production.
- To be responsible for implementation of manufacturing with coordination of all resources, QC for in process testing, facility maintenance, engineering, and administrative support.
- Solve comprehensive manufacturing problems including prioritizing manufacturing activities, schedules, and resources in aligning with company’s priority.
- To be responsible for the team building, budgeting, project timeline management, personnel training and performance evaluation of the manufacturing team.
- Collaborate with quality departments on facility qualification including utility calibration and validation, process validation, personnel GMP training, environment monitoring, QC testing, and final product releasing.
- Assist regulatory affair activities for DMF, IND, and NDA/BLA submission.
- Other assignments from the direct manager.
Minimum Requirements:
- Graduate degree in biochemical engineering, biological sciences or related field. Minimum 10 years biopharmaceutical experiences with ~5 years managerial responsibilities at a level of senior manager of a department. Ph.D. is a plus.
- Extensive experiences with microbial fermentation, mammalian cell culture, protein purification, formulation, viral vector production, and PAT in in-process testing.
- Extensive large scale manufacturing experiences with GMP operation background.
- Extensive management experiences. Strong leadership, organization ability, wide range of GMP knowledge on FDA or EMA or CFDA regulation.
- The candidate must be excellent with bilingual (English and Chinese) communication, professional writing and interpersonal skills.
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Responsibilities:
- Work with the technology transfer department to finished the process & engineering amplification and process optimization.
- To be responsible for pilot scale production and clinical production.
- To be responsible for implementation of manufacturing with coordination of all resources, QC for in process testing, facility maintenance, engineering, and administrative support.
- Solve comprehensive manufacturing problems including prioritizing manufacturing activities, schedules, and resources in aligning with company’s priority.
- To be responsible for the team building, budgeting, project timeline management, personnel training and performance evaluation of the manufacturing team.
- Collaborate with quality departments on facility qualification including utility calibration and validation, process validation, personnel GMP training, environment monitoring, QC testing, and final product releasing.
- Assist regulatory affair activities for DMF, IND, and NDA/BLA submission.
- Other assignments from the direct manager.
Minimum Requirements:
- Graduate degree in biochemical engineering, biological sciences or related field. Minimum 10 years biopharmaceutical experiences with ~5 years managerial responsibilities at a level of senior manager of a department. Ph.D. is a plus.
- Extensive experiences with microbial fermentation, mammalian cell culture, protein purification, formulation, viral vector production, and PAT in in-process testing.
- Extensive large scale manufacturing experiences with GMP operation background.
- Extensive management experiences. Strong leadership, organization ability, wide range of GMP knowledge on FDA or EMA or CFDA regulation.
- The candidate must be excellent with bilingual (English and Chinese) communication, professional writing and interpersonal skills.
职能类别： 生物工程/生物制药
公司介绍
杰科生物成立于2015年，公司坐落于天津滨海新区中新生态城。
杰科生物产业定位于高端生物医药，产品涵盖单克隆抗体、重组蛋白、溶瘤病毒、免疫毒素、疫苗等。依托于我们可持续的强大创新研发实力、备受业界推崇的设备设施配置、遵循GMP的全过程管理体系以及最重要的——不断壮大的优秀人才团队，我们从研发、生产到上市，覆盖生物医药产业全链条。
杰科生物致力于研发生产创新医药，在满足自身发展的同时，我们积极面向全球客户展开共赢合作，为客户定制和提供优质产品和增值服务，乃至完整的解决方案。
杰科生物产业定位于高端生物医药，产品涵盖单克隆抗体、重组蛋白、溶瘤病毒、免疫毒素、疫苗等。依托于我们可持续的强大创新研发实力、备受业界推崇的设备设施配置、遵循GMP的全过程管理体系以及最重要的——不断壮大的优秀人才团队，我们从研发、生产到上市，覆盖生物医药产业全链条。
杰科生物致力于研发生产创新医药，在满足自身发展的同时，我们积极面向全球客户展开共赢合作，为客户定制和提供优质产品和增值服务，乃至完整的解决方案。
联系方式
- 公司地址：中新生态城中滨大道2633号 (邮编：300467)