Senior Director, Drug Product Commercial Manufacturing

We are seeking a Chemical Engineer experienced in small-molecule Drug Product process development and commercial manufacturing. The candidate will support the commercial manufacturing of QINLOCK™ and ROMVIMZA™, and provide input to the development and clinical supply of new medicines. This role involves working with global CDMO partners and requires hands-on experience with GMP drug products, regulatory writing, quality management, and oversight of CDMO activities.Key Responsibilities:Oversee CDMOs to support qualification, supply, cGMP manufacture, and lifecycle management activities.Develop and maintain strong relationships with CDMO business partners.Lead process tech-transfers and PPQs to support supply chain expansion and continuous improvement initiatives.Review GMP documentation and support investigations and CAPA implementation.Author and review technical reports and SOPs in collaboration with QA.