Director, Small Molecule - Technical Product Leader

Lead the Development Commercialization Team (DCT) at Line of Sight to Commercial Product Definition Guide drug product candidates from late-stage development to launch and transition to supply Support the Value Chain Management Team (VCMT) in realization of product lifecycle strategy Deliver an integrated, stage-appropriate development and commercialization strategy to achieve the target commercial product Lead the cross-functional DCT, assess team deliverables, foster collaboration, and mitigate risks Oversee on-time execution of DCT deliverables, including processes and analytics, control strategy, tech transfer packages, filing and approval, and commercial supply chain Represent CMC across governance bodies, stakeholders, and teams to drive decisions and outcomes Influence and challenge xDT strategy to ensure a robust CMC strategy Balance speed, cost, and robustness to achieve the target commercial product Oversee VCMT deliverables, including new nodes and filings Create and lead high-performing teams and develop team members Requirements Bachelor’s degree in science or engineering related discipline with 10 or more years of experience, or an Advanced degree with 7 or more years of experience Technical depth and breadth in at least one CMC function Expertise across Drug Substance, Drug Product, Analytical, Device, Packaging, Regulatory, Quality, and Supply Chain Understanding of connectivity between clinical, CMC, and HH Cross-functional leadership Decision making and risk management Drug product manufacturing External manufacturing GMP compliance Manufacturing scale-up Process improvements Product management leadership Regulatory CMC Small molecules Stakeholder engagement Strategic thinking Supply chain Ability to lead complex discussions, influence stakeholders, and drive outcomes No visa sponsorship available 10% travel required Core Competencies Demonstrates expertise in CMC functions, including Drug Substance, Drug Product, and Regulatory processes, while leading cross-functional teams to drive product commercialization and lifecycle strategies. Proven ability to manage risks, influence stakeholders, and ensure compliance with GMP standards. Highest-signal resume keywords Cross-Functional Leadership Regulatory CMC GMP Compliance Drug Product Manufacturing Strategic Thinking ATS Optimization Keywords Hard Skills Drug Substance Drug Product Analytical Device Packaging Quality Supply Chain Manufacturing Scale-Up Process Improvements Product Management Leadership Soft Skills Decision Making Risk Management Stakeholder Engagement Influencing Driving Outcomes Industry Keywords CMC Commercialization Strategy Value Chain Management Tech Transfer Clinical Connectivity Small Molecules #J-18808-Ljbffr Jobtailor