Senior Biotech Manufacturing Director
vor 2 Wochen
Job Overview:
We are seeking an experienced Senior Biotech Manufacturing Director to join our team at Progressive Recruitment. As a key member of our organization, you will play a crucial role in the development and execution of our CMC strategy.
Key Responsibilities:
- Strategic Development: Lead the development of technical and manufacturing strategies for our visugromab program, ensuring all CMC activities meet timelines, budget, and quality standards.
- Manufacturing & Supply: Oversee the production and timely release of materials for non-clinical and clinical use, managing the clinical supply chain to meet program plans.
- GMP Compliance: Ensure 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.
- 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 We Offer:
- 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.
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