Director of Drug Product
Barrington James, California, MO, United States
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.
Key Responsibilities
- 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
Required Qualifications:
- 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