Director of Drug Product

I am currently supporting a publicly traded organization that is seeking a hands‑on Drug Product leader to support two lyophilized small‑molecule programs advancing through Phase 3 and toward NDA submission. This role is critical to ensuring PPQ execution, PAI readiness, and successful commercialization within a fully outsourced manufacturing model. The ideal candidate brings deep, direct lyophilization expertise and proven late‑stage regulatory experience and can step in immediately without ramp‑up time.

• Lead drug product strategy for late‑stage lyophilized small‑molecule programs
• Drive Phase 3 execution, NDA submission support, and PAI readiness
• Oversee CDMOs through pre‑PPQ and PPQ activities
• Ensure vendor inspection readiness, validation robustness, and regulatory compliance
• Author and review CMC documentation
• Partner cross‑functionally with Regulatory, Quality, and Clinical teams
• Manage consultants and external partners as needed
• Contribute tactically (documents, data review, tracking tools) — not solely delegate

• Several years of direct, hands‑on lyophilization (freeze‑drying) experience
• Must be execution‑based, not adjacent exposure
• Strong small‑molecule drug product background.
• Biologics‑only profiles are not suitable
• Phase 3 programs
• NDA submissions
• PAI readiness
• PPQ / process validation (Drug Product perspective)
• Experience operating within a virtual manufacturing model
• Proven ability to hold CDMOs accountable for inspection readiness
• Typically 10–12+ years of total industry experience
• A meaningful portion must be directly focused on lyophilized products