Director of Manufacturing

Director of Manufacturing CDMO North Carolina $180k - $250k Role Overview 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. Key Responsibilities 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. Candidate Profile 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. #J-18808-Ljbffr