Associate Director Drug Product

JOB REQUIREMENTS: Job Description Promega is seeking a visionary andmission-driven Director of Drug Product Manufacturing to architect andlead our in-house, FDA-compliant encapsulation, bottling, and packagingcapabilities. This role is a transformational leadershipopportunity-establishing Promega as a center of excellence in oral soliddose manufacturing, beginning with psilocybin-based therapies andexpanding to other emerging small molecules. This leader will shape bothinfrastructure and culture-designing future-ready, tech-integrated GMPsystems that embody our operational values and support long-termtherapeutic access through Usona. A critical component of this role willinvolve the strategic application of AI, not as a buzzword, but as apragmatic tool to optimize manufacturing, strengthen quality systems,and ensure inspection readiness. This is a rare opportunity to buildsomething foundational and lasting-a model of modern, digitally enableddrug product operations that reflects the integrity and innovation atthe 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. Thisleader will shape both infrastructure and culture-designingfuture-ready, tech-integrated GMP systems that embody our operationalvalues and support long-term therapeutic access through Usona. Acritical component of this role will involve the strategic applicationof AI as a pragmatic tool to optimize manufacturing, strengthen qualitysystems, and ensure inspection readiness. CORE DUTIES: 1. Lead andexecute the strategy for in-house drug product manufacturing, focused onscalability, compliance, and speed-to-readiness. 2. Serve as technicaland operational lead for facility design, cleanroom layout, and GMP flowoptimization. 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 andfuture 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 AItools into daily operations-for predictive maintenance, deviationtrending, and continuous process verification. 8. Implement and stewarddata management and data governance frameworks that ensure all DrugProduct Manufacturing data is captured with high-quality metadata,structured for machine actionability, and... For full info followapplication link. Diversity is important at Promega. We are proud to bean Equal Opportunity Employer, and make employment decisions withoutregard to race, color, religion, sex, sexual orientation, genderidentity, national origin, veteran status, disability, or any otherprotected class. APPLICATION INSTRUCTIONS: Apply Online:ipc.us/t/FFEE05C9FEAE4242 Qualified females, minorities, and specialdisabled veterans and other veterans are encouraged to apply.

Created: 2025-12-18