Production Manager – 503B Outsourcing-Facility

Our client is a 503B outsourcing facility commercializing a portfolio of ten sterile pre-filled syringe SKUs across five molecules (Ketamine, Lidocaine, Glycopyrrolate, Rocuronium, Succinylcholine). This position reports directly to the CEO. They’re in need of a Production Manager to own day-to-day sterile production end-to-end – from material release through aseptic fill, visual inspection, and final release handoff to QA. This is a hands-on leadership role at a growing 503B. Because they’re in early stages, the Production Manager will operate as a senior operating leader, not as a layer in a 100-person factory. You will set up the production cadence, write what isn’t written, troubleshoot what hasn’t been seen before, and stay on the floor. They run DataNinja eBR, NetSuite, MasterControl, and OceanView, and actively deploying AI-augmented exception triage and inspection-readiness tooling. The Production Manager will help shape that roadmap, not just operate inside it.