Production Director

Associate Director - Quality & Technical Operations Europe

Director of GMP Production

About the Company

Our client is a fast-growing biopharmaceutical company dedicated to advancing novel therapies through clinical development and commercialization. With state-of-the-art GMP manufacturing capabilities, they are committed to ensuring high-quality production of innovative biologics and advanced therapies for patients worldwide.

The Role

We are seeking an experienced Director of GMP Production to lead and oversee all clinical manufacturing operations at our GMP facility. This is a key leadership position responsible for ensuring the production of clinical trial materials meets the highest quality, safety, and compliance standards while supporting the company’s development and regulatory milestones.

Key Responsibilities

• Lead and manage GMP production for clinical trial manufacturing of biologics and advanced therapeutic products
• Oversee day-to-day operations across production, site engineering, and quality control teams
• Ensure strict compliance with international GMP, EMA, and FDA regulatory requirements
• Drive continuous improvement initiatives to optimize manufacturing efficiency, cost-effectiveness, and scalability
• Collaborate cross-functionally with QA, Regulatory Affairs, Supply Chain, and R&D teams to align production activities with clinical and corporate objectives
• Manage external manufacturing partners (CMOs/CDMOs) and ensure alignment with project timelines and quality standards
• Support technology transfer, process validation, and readiness for future commercial scale-up
• Develop and mentor production and operational teams to ensure a culture of accountability, quality, and innovation

Requirements

• Advanced degree (PhD, MSc, or equivalent) in Biotechnology, Bioprocess Engineering, Pharmacy, or related field
• 10+ years of experience in GMP manufacturing within the biopharma or biologics industry, including at least 5 years in a leadership role
• Proven experience overseeing clinical trial manufacturing and working within a regulated GMP environment
• Strong understanding of cell culture, purification, fill-finish, or viral vector production processes (depending on modality)
• Demonstrated success in building and leading high-performing teams in a fast-paced, dynamic environment
• Excellent communication, leadership, and stakeholder management skills

Note: This description reflects the requirements and responsibilities for the role and does not include extraneous postings or unrelated content.

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