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GMP Manager / Laboratory Manager (m/w/d)
Biotechnologie, GMP, Labor, Mikrobiologie
GMP Manager / Laboratory Manager (m/f/x) Datum: 19.08.2020 Standort: Pfaffenhofen an der Ilm, Deutschland, 85276 Unternehmen: Daiichi Sankyo Europe Affiliate: Daiichi Sankyo Europe GmbH Passion for Innovation. Compassion for Patients.™ Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For more information: www.daiichi-sankyo.eu. For our R&D Biologics Unit in Pfaffenhofen an der Ilm we are seeking highly qualified candidates to fill the position of GMP Manager / Laboratory Manager (m/f/x) –2 year contract- Purpose of the function: As a Laboratory Manager, the job holder is a First Line Manager leading 1-2 technicians and is responsible for the timely execution of manufacturing projects of biologics at R&D level. This includes the development and optimization of fermentation processes with both microbial and mammalian cell lines as well as purification processes. You will assist in the method transfer to clinical GMP production. Roles and Responsibilities: Responsibility for planning and execution of manufacturing projects recombinant proteins Including upstream fermentation and downstream purification tasks Development and optimizing of fermentation processes with microbial and mammalian cell lines Planning and execution of genetic engineering tasks Responsibility for a laboratory team Training and leading technicians and students conduction laboratory tasks as experiments, fermentation, purification tasks as well as maintenance of equipment Responsible for personal development of laboratory team members Regular reporting and communication with Japanese colleagues Participation in research exchange program Laboratory maintenance and organization of dedicated lab equipment including writing of SOPs Reading and interpretation of scientific literature Contribution to equipment qualification and risk analysis within the scope of establishing a GMP environment Assist in method transfer from R&D level to clinical GMP production Personal skills and professional experience: University Degree in Biotechnology or related subjects 2-5 years working experience in the pharmaceutical industry Working experience in a GMP enviroment Hands-on experience with prokaryotic and eukaryotic fermentations Proven knowledge of protein expression strategies General molecular biology skills (cloning, vector construction, PCR) Knowledge in protein purification methods Language requirements: English (advanced-fluent written and spoken) and German (proficient) IT skills: office software; experienced with statistical programs