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
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