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 requestedIhre Aufgaben
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
Ihr Profil
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
Wir bieten
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
Expected salary
Location
Wien
Job date
Fri, 05 Jul 2024 07:14:55 GMT
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