Director, Commercial Manufacturing & Process Engineering
Job Description
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.
Qualifications
Qualifications
- 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 Information Deciphera 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! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. Apply To This Job