Director Production Operations
WuXi AppTec · Middletown, Delaware, US
Overview We are seeking an experienced Director- Pharmaceutical Production Operation, to provide end-to-end leadership for our CDMO drug-product operations w...
Job description
Overview We are seeking an experienced Director- Pharmaceutical Production Operation, to provide end-to-end leadership for our CDMO drug-product operations which covers all manufacturing and packaging functions. The Middletown facility will produce oral solid dosage and sterile products. The person should be a customer focused business model with responsible to set strategy, ensure compliance with all regulatory requirements, deliver reliable supply, and drive continuous improvement across people, processes, and technology. This role drives compliance with Good Manufacturing Practices (GMP), regulatory standards (FDA, EMA, ICH), and company policies. Responsibilities: Key Responsibilities: - Facility Start-up : Support facility delivery and operational readiness for new greenfield facilities. Lead collaboratively and energetically across all aspects of operational readiness and startup. Build an organization with the capability, capacity, and culture to achieve high standards in safety, quality, and operational excellence. Develop and implement site systems and processes, drawing on internal expertise and external best practices. Act as the end-user representative during project de...