职位描述
Talent@Boehringer Ingelheim
About Biopharmaceutical Contract Manufacturing
Boehringer Ingelheim aims to become China’s first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China’s biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China’s innovative medicines in a bid to accelerate growth of China’s bio-technology industry. The Company’s state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.
Job Responsibilities
-Perform upstream processing, optimization and scale up to meet all quality and regulatory demands. Carry out preclinical and clinical manufacturing of drug substance under GMP conditions.
-Handle operational work packages within the team including change-over, scale up, fermentation and in-process controls.
-Exchange with colleagues in order to ensure best-practise sharing and best use of resources in accordance with the supervisor.
-Specialist for fermentation topics, inoculum and IPC within GMP requirements. Power user of Single Use Bioreactor and FlexAct (Sartorius) systems as well as other relevant equipment used in BI. Support trouble shooting and problem solving.
-Ensuring good communication, material and data hand over with internal and external customers and interfaces as downstream, QC, R&D and transfer partners.
Qualifications
-Degree: Bachelor/Master
-Major: Biotechnology, Bioengineering, Biopharmaceuticals, Biology, Biochemistry
-Knowledge about fermentation and upstream processing
-Basic knowledge and general understanding of cGMP and documentation according to GMP
-Practical experience with fermentation and related analytical methods (e.g. cell counter, analysis of metabolites)
-Basic knowledge of the actually used equipment and systems in BI China, such as disposable bioreactor and FlexAct
-Analytical and scientific thinking, clear argumentation and ability to reduce complex issues to the main points
-Basic experience in inoculums, scale-up, fermentation, harvest. Capability to become a highly motivated team player and to move up as a specialist for upstream process.
-Language skills & proficiency: English (oral and written)and Chinese (fluent)
-At least 1 year experience with GMP, Upstream process related equipment, process understanding
