We are seeking an experienced manufacturing and process engineering leader to support the commercialization and lifecycle management of our commercial-stage pharmaceutical products. Operating within a fully outsourced manufacturing model, this role will oversee commercial manufacturing, technical transfer, process optimization, scale-up, validation, and continuous improvement activities across drug substance and drug product programs.
The Director will serve as a key technical and operational leader, partnering cross-functionally with Technical Operations, Quality, Supply Chain, Regulatory, and external CDMO/CMO partners to ensure reliable product supply, regulatory compliance, and operational excellence from late-stage development through commercialization.
Key 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.
QualificationsQualifications- 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.
- Experience authoring and supporting Module 3 CTD submissions through approval and commercialization preferred.
- Strong leadership, communication, problem-solving, and stakeholder management skills.
- Ability to travel up to 30% domestically and internationally.
Preferred Qualifications- Experience supporting oncology and/or orphan disease products.
- Advanced degree or MBA preferred.
- Experience with statistical analysis tools such as JMP is a plus.
Additional InformationDeciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $184,000 - $253,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
Benefits:- Competitive salary and annual bonus.
- 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.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
