Job Information
PROMEGA CORPORATION Associate Director Drug Product in MADISON, Wisconsin
JOB REQUIREMENTS: Job Description Promega is seeking a visionary and mission-driven Director of Drug Product Manufacturing to architect and lead our in-house, FDA-compliant encapsulation, bottling, and packaging capabilities. This role is a transformational leadership opportunity-establishing Promega as a center of excellence in oral solid dose manufacturing, beginning with psilocybin-based therapies and expanding to other emerging small molecules. This leader will shape both infrastructure and culture-designing future-ready, tech-integrated GMP systems that embody our operational values and support long-term therapeutic access through Usona. A critical component of this role will involve the strategic application of AI, not as a buzzword, but as a pragmatic tool to optimize manufacturing, strengthen quality systems, and ensure inspection readiness. This is a rare opportunity to build something foundational and lasting-a model of modern, digitally enabled drug product operations that reflects the integrity and innovation at the heart of Promega and Usona. JOB OBJECTIVE: The Associate Director, Drug Product Manufacturing will architect and lead our in-house, FDA-compliant encapsulation, bottling, and packaging capabilities. This leader will shape both infrastructure and culture-designing future-ready, tech-integrated GMP systems that embody our operational values and support long-term therapeutic access through Usona. A critical component of this role will involve the strategic application of AI as a pragmatic tool to optimize manufacturing, strengthen quality systems, and ensure inspection readiness. CORE DUTIES: 1. Lead and execute the strategy for in-house drug product manufacturing, focused on scalability, compliance, and speed-to-readiness. 2. Serve as technical and operational lead for facility design, cleanroom layout, and GMP flow optimization. 3. Create and maintain detailed project plans, timelines, and budgets. 4. Select and qualify equipment (e.g., capsule fillers, bottling systems, blister packaging), with attention to both current and future therapeutic needs. 5. Oversee commissioning, qualification (IQ/OQ/PQ), process validation, and PPQ batches to support NDA filings. 6. Contribute to CMC content, coordinate submission-ready documentation, and collaborate with regulatory on dossier content. 7. Integrate AI tools into daily operations-for predictive maintenance, deviation trending, and continuous process verification. 8. Implement and steward data management and data governance frameworks that ensure all Drug Product Manufacturing data is captured with high-quality metadata, structured for machine actionability, and... For full info follow application link. Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/FFEE05C9FEAE4242 Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.