Director of Manufacturing

Director of Manufacturing CDMO

North Carolina

$180k - $250k

You will lead end‑to‑end manufacturing operations for a fast‑growing Contract Development & Manufacturing Organization (CDMO) supporting small‑molecule, biologics, or sterile‑fill drug programs. This role is pivotal in ensuring compliant, efficient, and scalable production across clinical and commercial supply.

• Own the full manufacturing strategy, capacity planning, and operational performance across multiple production suites.
• Lead and develop high‑performing teams across manufacturing, tech ops, MSAT, and production support.
• Drive right‑first‑time execution, batch throughput, and continuous improvement initiatives (Lean/Six Sigma).
• Partner with Quality, Engineering, Supply Chain, and Program Management to ensure seamless tech transfer and flawless GMP execution.
• Oversee manufacturing readiness for regulatory inspections (FDA, EMA) and client audits.
• Implement robust KPIs, digital manufacturing tools, and operational excellence frameworks.
• Champion safety culture, deviation reduction, and process robustness.

• 10+ years in GMP manufacturing within pharma/biotech; CDMO experience strongly preferred.
• Proven leadership of multi‑shift operations and complex drug modalities (biologics, sterile injectables, or high‑potency small molecules).
• Strong understanding of regulatory frameworks, batch record compliance, and tech transfer.
• Demonstrated ability to scale operations during periods of rapid client growth.
• Influential communicator able to manage client expectations and internal stakeholders.