職位描述
職位描述：
Basic Purpose of the Position*
崗位的基本目標(biāo)*
Primary responsibility is operational work on Upstream process (disposable) under GMP conditions for the Biolab and later OASIS, including media preparation, inoculum, fermentation, harvest and IPC analytic.
Coordination and planning of equipment to ensure timely material supply. Ensuring GMP readiness of facility and equipment (e.g. performing of calibration and maintenance). Supporting process transfer activities from internal and external clients.
Oversee daily work package and coordinate work coverage among the team.
Responsible for processing of economic and robust fermentation process for therapeutic proteins and monoclonal antibodies by applying state of the art technologies to ensure manufacturing of bulk drug substance and bulk drug product.
Being part of process transfer teams to secure material supply for projects to support preclinical and clinical studies.
Accountabilities 職責(zé)
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.
Required Education 所需的教育背景
Bachelor/ Master degree with major in Biopharmaceuticals, Biology, Biochemistry, Biotechnology, and Bioengineering
Required Capabilities (Skills, Experience, Competencies)
所需的能力(技能、經(jīng)驗(yàn)、勝任能力)
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 Experience
所需的工作經(jīng)驗(yàn)背景
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.
