Director Global Manufacturing and CMC
vor 4 Wochen
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
YOUR FUTURE ROLE
- 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
JOB REQUIREMENTS
- 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 convin
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