[Remote] Director, Commercial Manufacturing & Process Engineering

Note: The job is a remote job and is open to candidates in USA. Deciphera Pharmaceuticals is seeking an experienced manufacturing and process engineering leader to support the commercialization and lifecycle management of their commercial-stage pharmaceutical products. The role involves overseeing commercial manufacturing, technical transfer, process optimization, and ensuring compliance and operational excellence across various programs.ResponsibilitiesLead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiativesDrive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial productsSupport regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responsesOversee CDMO/CMO relationships, ensuring strong technical, operational, quality, and regulatory performance across the supply chainPartner cross-functionally to support successful product launches, technology transfers, supply chain expansion, and post-approval improvementsLead operational improvement initiatives utilizing Lean/Six Sigma methodologies to improve efficiency, reduce costs, and enhance manufacturing performanceManage project timelines, deliverables, and budgets while ensuring alignment with overall business and technical operations strategySkillsBachelor's or Master's degree in Chemical Engineering, Pharmaceutics, Chemistry, or related life sciences discipline10+ years of experience in pharmaceutical or biopharmaceutical CMC development, commercialization, and manufacturingStrong experience managing drug substance and/or drug product manufacturing programs in regulated environmentsDemonstrated success working with CDMO/CMO partners and leading cross-functional technical operations initiativesDeep knowledge of cGMPs, process validation, regulatory CMC requirements, and global drug development processesStrong leadership, communication, problem-solving, and stakeholder management skillsAbility to travel up to 30% domestically and internationallyExperience authoring and supporting Module 3 CTD submissions through approval and commercialization preferredExperience supporting oncology and/or orphan disease productsAdvanced degree or MBA preferredExperience with statistical analysis tools such as JMP is a plusBenefitsAnnual performance bonusA long-term incentive planFull range of benefitsComprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.Generous parental leave and family planning benefitsOutstanding culture and opportunities for personal and professional growthCompany OverviewDeciphera Pharmaceuticals focuses on improving kinase inhibitor treatments. It is a sub-organization of ONO Pharmaceutical. It was founded in 2003, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 201-500 employees. Its website is http://www.deciphera.com/.Company H1B SponsorshipDeciphera Pharmaceuticals has a track record of offering H1B sponsorships, with 1 in 2026, 3 in 2025, 2 in 2023, 5 in 2022, 5 in 2021, 9 in 2020. Please note that this does not guarantee sponsorship for this specific role.