Director Manufacturing Science and Technology Operations (MST)

Job description

Overview We are seeking an experienced Director- Technical Operations (MS&T), to provide scientific leadership expertise for our CDMO drug-product technical operations team 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 with responsibility to set transfer strategy, ensure compliance with all regulatory requirements, deliver reliable processes, 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: New Product Introduction and Co-line Evaluation - Manage the process of new product introduction and co-line evaluation. - Guide department employees in reviewing and assessing the new product introduction information provided by the R&D department. For complex cases, organize communication and coordination with key personnel from relevant departments to make decisions. - Guide department employees in drafting co-line evaluation reports. For complex cases, organize internal discu...