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, media preparation, 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 · Work within a team of technical and scientific personnel in a complex lab in a disciplined and efficient manner · Good Documentation Practice in daily work life

Job Requirements

Bachelor/ Master degree with major in Biopharmaceuticals, Biology, Biochemistry, Biotechnology, and Bioengineering · 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 · Knowledge about fermentation and upstream processing · Basic knowledge and general understanding of cGMP and documentation according to GMP · Good understanding of organizing a lab · 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 · Self confidence · Social competence, customer orientation and team player · This individual will be goal-oriented and focused on meeting deadlines in the required quality within a highly competitive environment · This individual will work hands-on in a cGMP laboratory and also perform cGMP documentation, shift work and week end work will occur on periodic basis

Required Languages

English