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 requested Lead and improve manufacturing capabilities for the autologous cancer vaccine production according to GMP requirements Lead, improve and redefine CMC aspects for the characterization of the product fulfilling regulatory requirements Improve 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 departments According to company´s need establish new manufacturing sites including manufacturing sites in the US Degree in Life Science (PhD) Minimum of 10+experience in manufacturing and CMC from HQs Experience in global roll-out of manufacturing capabilities Experience in establishing CMC strategy for biologic and / or cell-derived products Profound knowledge of regulatory requirements and guidelines (must have) Profound knowledge and experience in manufacturing fulfilling GMP requirements (must have) Background in immunology and vaccine development Excellent communication and leadership capabilities High level English skills (oral / written) are requested Strong, mature, hands-on leader with convincing decision-making, negotiating, and influencing skills Driven teamplayer and individual performer according to needs, ready to work and to develop again in a dynamic biotech setting You are a bold, curious, goal-oriented, result and mission-driven, entrepreneurial-minded RA-professional equipped with strong analytical skills Open, dynamic and positive, diverse company culture with short decision-making and freedom to operate – offering an expert-context to set your individual footprint A meaningful position aimed at significantly improving the clinical outcome and quality of life for cancer patients Smart working

Director Global Regulatory Affairs (f/m/x)

Talentor Austria GmbH, Vienna, Wien

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 successfully drive the global regulatory strategy and execution of the lead candidate and additional pipeline candidates we are searching a driven and hands-on Director Global Regulatory Affairs: a hands-on RA-allrounder-personality with profound knowledge in driving global regulatory affairs from headquarters, preferably with experience in seeking EMA and FDA approval of 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 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 Regulatory Affairs (f/m/x) PhD and HQ-Can do-experience are requested Lead and develop regulatory strategy for the lead candidate and pipeline candidates Lead, improve and redefine regulatory strategy and activities for all areas of product development (pre-clinical, CMC and manufacturing and clinical) Drive in cross-functional execution and alignment Establish and execute all regulatory affairs related activities across functions focusing on Europe and USA Lead interactions with regulatory bodies including EMA and FDA Lead interactions with regulatory consultancy firms Degree in Life Science (PhD) Minimum of 10+experience in global regulatory affairs from HQs Experience in leading interactions with regulatory bodies including EMA and FDA Track record of successful filings of biologics, cell-therapies with EMA and FDA Background in immunology, vaccine development and / or cell therapies preferred Excellent communication and leadership capabilities High level English skills (oral / written) are requested Strong, mature, hands-on leader with convincing decision-making, negotiating, and influencing skills Driven teamplayer and individual performer according to needs, ready to work and to develop again in a dynamic biotech setting You are a bold, curious, goal-oriented, result and mission-driven, entrepreneurial-minded RA-professional equipped with strong analytical skills Open, dynamic and positive, diverse company culture with short decision-making and freedom to operate – offering an expert-context to set your individual footprint A meaningful position aimed at significantly improving the clinical outcome and quality of life for cancer patients Smart working

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