We are seeking a results-oriented, innovative, broadly experienced, CMC leader who will lead and manage Deciphera’s Analytical Development & Quality Control organization. The incumbent will continue to build and develop a team with technical competencies in method development and QC to support GMP manufacture and commercialization of small molecule, ASO and biologic drug substances and a spectrum of dosage forms ranging from oral solid doses to and including injectables and topicals. Operating within a largely outsourced business model, the successful candidate will have responsibility for all analytical development and quality control activities associated with Deciphera’s clinical-stage and commercial-stage portfolio of programs, ranging from the discovery/development interface (lead optimization stage) through registration and commercialization and may include the evaluation of potential in-licensing candidates. The scope of the role will encompass analytical characterization of products/processes and the development, qualification, transfer and validation of analytical methods for QC release and stability testing of small-molecule and large molecule drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components. The incumbent will model strategic thinking, a global, enterprise-wide vision and relentless focus on quality, reliability, consistency, global regulatory acceptability, capacity, cost efficiency and operational performance. The role requires an individual who is highly organized, detail-oriented, timeline-driven, decisive, and capable of approaching the role from both a strategic and operational mindset. They will have significant experience in CMC development and commercialization of small and large molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with product registration and commercialization of biopharmaceutical products. Also critical is strategic and practical experience navigating the pharmaceutical/CMC regulatory landscape of the US, EU, and Japan and the ability to manage critical conversations with global regulatory agencies.  They will lead a team of talented analytical development and quality control professionals and serve as an integral member of the Pharmaceutical Development Leadership Team.What You’ll Do:Lead and manage an Analytical Development & Quality Control organization to enable successful development, registration and commercialization of Deciphera and ONO Pharmaceuticals products in U.S. and international markets, including partnering arrangements through geography specific distribution agreements and collaboration & license agreements.Establish and implement the enterprise-wide vision for the Analytical Development & Quality Control organization and set the strategy to enable global development and commercialization of Deciphera/ONO assets.Ensure cross-functional alignment and integration of Analytical Development & Quality Control strategy and deliverables with overarching Pharmaceutical Development & Manufacturing program/asset strategy.Define and manage scope, milestones and interdependencies, and assume ownership for budgets and timelines associated with analytical development and commercialization program deliverables.Establish selection of analytical service providers, e.g., CROs and CDMOs, based upon core capabilities, capacity and track record of regulatory compliance and operational performance; establish KPIs to monitor site technical, quality and business performance.Lead and oversee small-molecule, ASO, and biological molecule product/process characterization activities and the development, validation and site implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.Partner with Global Supply Chain, Chemical Development, Drug Product Development, Pharmaceutical Engineering & Commercial Manufacturing, Quality Assurance and related CMC disciplines, as appropriate, to ensure uninterrupted supply of CTM and commercial product.Oversee stability operations and reference standard management.Ensure high quality of technical reports, controlled GMP documents (e.g., analytical methods and associated validation protocols, specifications, change controls, LIRs, SOPs, etc.) and CMC content for Module 3 CTDs.Lead the development, negotiation and operationalization of relevant sections of MSA and CSA agreements.Provide technical and business leadership in supporting in-licensing and/or out-licensing opportunities and external collaboration agreements.Provide leadership in regulatory CMC strategy and guidance in the development, review and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs.Ensure success of analytical method transfers and site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.Develop and maintain strong relationships with CRO and CDMO business partners and support Joint Steering Committee meetings, as needed.Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address development and manufacturing risk.Represent Pharmaceutical Development & Manufacturing in meetings with FDA, EMA and related regulatory authorities.
