Director Global Manufacturing and Cmc

vor 4 Wochen

Wien, Österreich Talentor Sweden AB Vollzeit

**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 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

***OUR CLIENT OFFERS**:

- 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

***ARE YOU INTERESTED?**:

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