Director of CMC
vor 1 Monat
Our client, a leading biotech company based near Munich, is seeking a highly experienced Director of CMC to play a crucial role in developing and executing the CMC strategy, ensuring the timely supply and quality of clinical trial materials essential for both non-clinical and clinical development. The company is focused on developing immunotherapies aimed at transforming the lives of cancer patients by effectively mobilizing their immune systems to fight cancer. Their mission is to swiftly deliver next-generation immuno-oncology products to patients in need.
Key Responsibilities:
- Strategic Development: Implement technical and manufacturing strategies for the visugromab program, ensuring all CMC activities meet timelines, budget, and quality standards while maintaining commercially viable costs.
- Manufacturing & Supply: Ensure production and timely release of materials for non-clinical and clinical use, managing the clinical supply chain to meet program plans.
- GMP Compliance: Oversee GMP-compliant development of drug substances and products, resulting in high-quality, robust, and high-yield processes.
- External Partnerships: Manage relationships with CDMOs, including defining requirements, leading negotiations with the COO, and coordinating external technical development and manufacturing.
- Team Integration: Represent the CMC and supply department within cross-functional teams, supporting corporate objectives.
Candidate Profile:
- Experience: At least 15 years in the pharmaceutical or biotech industry, with comprehensive responsibility for late-stage and/or commercial product development and manufacturing.
- GMP Manufacturing: Extensive knowledge and experience in GMP manufacturing of biologics.
- Expertise: Strong background in technical and analytical development, regulatory CMC expertise, and experience with Health Authorities (FDA, EMA) interactions. Proficient in early and late-stage development, commercial phase, validation procedures, and stability studies per ICH guidelines.
- CDMO Knowledge: Deep understanding of the CDMO landscape in biotech development and manufacturing.
- Regulatory Experience: Skilled in compiling the CMC sections of CTA/IND submissions.
- Leadership: Proven ability to lead and develop teams.
What's in it for you?
- Impactful Contribution: An opportunity to significantly contribute to a successful oncology clinical program.
- Innovative Environment: Be part of a dynamic, goal-driven biotech company making strides in the industry.
- Supportive Culture: Work within a collegial atmosphere characterized by a driven and supportive international team.
- Flexibility: Enjoy flexible work schedules with options for partial remote work.
If you're enthusiastic about making a difference and advancing your career, we'd love to hear from you
Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.
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