Director, Molecule- Technical Product Leader; TPL

Role Responsibilities

• Lead the Development Commercialization Team (DCT) from late-stage development to launch and transition to supply; subsequently support Value Chain Management Team (VCMT) for product lifecycle strategy.
• Deliver an integrated, stage-appropriate development and commercialization strategy yielding the target commercial product (accountable to the Development Commercialization Review Committee).
• Lead and direct the cross-functional DCT; assess deliverables, foster learning/collaboration, prioritize and mitigate technical/operational/regulatory risks, and develop innovative solutions.
• Provide end-to-end technical product leadership (TPL) and ensure on-time DCT execution (processes/analytics, integrated control strategy, tech transfer packages, filing/approval, and compliant commercial supply chain).
• Represent CMC to governance bodies/stakeholders; influence and challenge xDT strategy; balance Speed/Cost/Robustness to achieve target product.
• Provide on-time TPL oversight of VCMT deliverables (including new nodes and filings).

• BS in science/engineering with 10+ years experience, or Advanced degree with 7+ years experience.

• Technical depth across DS/DP/Analytical/Device/Packaging/Regulatory/Quality/Supply Chain; connects clinical and CMC/HH for launch.
• Strategic/enterprise thinking; ask critical questions; balance speed, cost, robustness.
• Data-driven problem solving; operate through ambiguity.
• Accountable leadership to deliver on-time milestones; create high-performing teams.
• Risk-based decision-making and risk management; clear direction in ambiguity.
• Productive communication and stakeholder influence.

• Cross-functional leadership, decision making, drug product manufacturing, GMP compliance, innovation, manufacturing scale-up, process improvements, regulatory CMC, stakeholder engagement, small molecules, supply chain.