Provide strategic and operational leadership for a multi‑product, FDA‑regulated manufacturing organization. This role shapes production strategy ensures compliant and efficient operations across multiple shifts and builds scalable manufacturing capabilities aligned to business objectives. Partnering cross‑functionally with R&D, Quality, Regulatory, Supply Chain, and Engineering, the role enables successful product transitions, drives continuous improvement, mitigates operational risk, and develops high‑performing teams to deliver quality, cost, and supply excellence.