Director Global Manufacturing and CMC (f/m/x)

Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell carcinoma. Our client's aim is to bring the first in class autologous cancer vaccine to the patients.To develop the manufacturing and CMC capabilities our client is searching for a Director Global Manufacturing & CMC (f/m/x): we are seeking a hands-on personality with profound knowledge in driving manufacturing and CMC from headquarters, preferably with experience in autologous tumor vaccines or cell-based therapies. You are the ideal candidate because of your pioneering mentality, your out of the box-thinking, your perceiving the big picture and on top because you are used to and ready to drive results in order to reach the goals. In particular to gain regulatory approval for the first in class autologous cancer vaccine in the pipeline.Director Global Manufacturing and CMC (f/m/x)PhD and HQ-Can do-experience are requestedYOUR FUTURE ROLELead and improve manufacturing capabilities for the autologous cancer vaccine production according to GMP requirementsLead, improve and redefine CMC aspects for the characterization of the product fulfilling regulatory requirementsImprove in cross-functional execution and alignment regarding CMC aspects of the products in line with regulatory requirements (EMA and FDA)Establish and execute all CMC related activities across functions (research, pre-clinical / bioanalytics and clinical)Lead and drive collaborations with external partners including contract manufacturer and bioanalytic departmentsAccording to company´s need establish new manufacturing sites including manufacturing sites in the USJOB REQUIREMENTSDegree in Life Science (PhD)Minimum of +experience in manufacturing and CMC from HQsExperience in global roll-out of manufacturing capabilitiesExperience in establishing CMC strategy for biologic and / or cell-derived productsProfound knowledge of regulatory requirements and guidelines (must have)Profound knowledge and experience in manufacturing fulfilling GMP requirements (must have)Background in immunology and vaccine developmentExcellent communication and leadership capabilitiesHigh level English skills (oral / written) are requestedStrong, mature, hands-on leader with convincing decision-making, negotiating, and influencing skillsDriven teamplayer and individual performer according to needs, ready to work and to develop again in a dynamic biotech settingYou are a bold, curious, goal-oriented, result and mission-driven, entrepreneurial-minded RA-professional equipped with strong analytical skillsOUR CLIENT OFFERSOpen, dynamic and positive, diverse company culture with short decision-making and freedom to operate – offering an expert-context to set your individual footprintA meaningful position aimed at significantly improving the clinical outcome and quality of life for cancer patientsSmart workingARE YOU INTERESTED? If you are interested in this new, unique and exciting challenge, we look forward to receiving your online application via our career portal. Our consultant responsible for you, Mag. Birgit Wandrak (), will contact you immediately after the receipt of your documents. We kindly ask you to support us in processing your documents in accordance with the GDPR and to refrain from sending an e-mail application.