Monday, October 27, 2025

Job Description

Director of GMP Production About the CompanyOur 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 RoleWe 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 ResponsibilitiesLead and manage GMP production for clinical trial manufacturing of biologics and advanced therapeutic productsOversee day-to-day operations across production, site engineering, and quality control teamsEnsure strict compliance with international GMP, EMA, and FDA regulatory requirementsDrive continuous improvement initiatives to optimize manufacturing efficiency, cost-effectiveness, and scalabilityCollaborate cross-functionally with QA, Regulatory Affairs, Supply Chain, and R&D teams to align production activities with clinical and corporate objectivesManage external manufacturing partners (CMOs/CDMOs) and ensure alignment with project timelines and quality standardsSupport technology transfer, process validation, and readiness for future commercial scale-upDevelop and mentor production and operational teams to ensure a culture of accountability, quality, and innovationRequirementsAdvanced degree (PhD, MSc, or equivalent) in Biotechnology, Bioprocess Engineering, Pharmacy, or related field10+ years of experience in GMP manufacturing within the biopharma or biologics industry, including at least 5 years in a leadership roleProven experience overseeing clinical trial manufacturing and working within a regulated GMP environmentStrong 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 environmentExcellent communication, leadership, and stakeholder management skills

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