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.
Responsibilities
- Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives
- Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products
- Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses
- Oversee CDMO/CMO relationships, ensuring strong technical, operational, quality, and regulatory performance across the supply chain
- Partner cross-functionally to support successful product launches, technology transfers, supply chain expansion, and post-approval improvements
- Lead operational improvement initiatives utilizing Lean/Six Sigma methodologies to improve efficiency, reduce costs, and enhance manufacturing performance
- Manage project timelines, deliverables, and budgets while ensuring alignment with overall business and technical operations strategy
Skills
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutics, Chemistry, or related life sciences discipline
- 10+ years of experience in pharmaceutical or biopharmaceutical CMC development, commercialization, and manufacturing
- Strong experience managing drug substance and/or drug product manufacturing programs in regulated environments
- Demonstrated success working with CDMO/CMO partners and leading cross-functional technical operations initiatives
- Deep knowledge of cGMPs, process validation, regulatory CMC requirements, and global drug development processes
- Strong leadership, communication, problem-solving, and stakeholder management skills
- Ability to travel up to 30% domestically and internationally
- Experience authoring and supporting Module 3 CTD submissions through approval and commercialization preferred
- Experience supporting oncology and/or orphan disease products
- Advanced degree or MBA preferred
- Experience with statistical analysis tools such as JMP is a plus
Benefits
- Annual performance bonus
- A long-term incentive plan
- Full range of benefits
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits
- Outstanding culture and opportunities for personal and professional growth
Company Overview
Deciphera 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 Sponsorship
Deciphera 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.