Drug Substance Operation

职位描述:
1.Provide local execution support during CTA lot execution at CROs/CMOs.
2.Lead execution of DS startup/scaleup/clinical lots production in new facility.
3.Author, review, and approve documentation such as batch records, procedures, and validation reports.
4.Collaborate cross-functionally with local and global team to troubleshoot/resolve issues and drive improvement.
5.Manage the DS team through the training, operations, performance etc.
6.Proactive and real-time RFT support of critical operations.
7.Communicate and resolve operational variances.
8.Process monitoring including real time review of process parameters and process data/trend analysis. Communicate process performance across shifts and departments.
9.Implement process enhancements, measure and respond to equipment capability and implement new technologies.
10.Provide input, review, and approval for investigations, commitments, and change controls to ensure changes are value added and processes and equipment are robust.
11.Perform skills training and provide subject matter expertise to training materials.
12.Promote a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.
13.Develop programs and strategies for real time process monitoring and right first time.
14.Provide Audit support as SME.
职位要求:
1.BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.
2.Familiarity and experience with mammalian cell culture, protein purification and/or solution formulation is not essential, but is highly desirable.
3.Previous experience in a GMP manufacturing environment desirable.
4.Previous experience with manufacturing-scale bioreactors/fermentors, centrifuge, column chromatography and/or tangential flow filtration (UF/DF) a plus.
5.Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus.
6.Enterprise Systems familiarity preferred, namely LabWare LIMS, SAP, TrackWise, PDOCS and EAMS.
7.Previous leadership skills a plus.
1458540472885 辉瑞制药
公司介绍
在辉瑞,我们致力于运用科学以及我们的全球资源来改善每个生命阶段的健康状况。在药品的探索、开发和生产过程中,我们致力于设定品质、安全和价值标准。我们多样化的全球保健产品包括生物药品、小分子药品和疫苗,以及许多世界驰名的健康药物。每天,世界各地的辉瑞员工致力于推进健康,以及能够应对我们这个时代最为棘手的疾病的预防和治疗方案。辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。

我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为卓越的创新型生物制药公司”。