Director of Manufacturing Operations
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About The Position
We are a diagnostics company focused on developing and commercializing a PMA-approved, single-site in vitro diagnostic (IVD) assay. Our organization is committed to regulatory rigor, operational excellence, and delivering high-impact solutions for early cancer detection. We are seeking a Director of Manufacturing Operations to lead and scale our on-site manufacturing capabilities. This role will oversee production, technology transfer, validation, and ongoing operational execution under a highly regulated, FDA-compliant environment. You will play a critical role in ensuring compliance with 21 CFR Part 820, ISO 13485, and PMA conditions of approval. You will also manage forecast headcount, capital and infrastructure needs in collaboration with Finance and Procurement.
