Head of Reagent Operations & Scale-Up

At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing hard scientific problems with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines.The Director of Reagent Operations will lead the end-to-end strategy and execution for reagent manufacturing, process transfer, and supply chain readiness to support commercial scale. This role sits at the critical interface of R&D, Quality, Supply Chain, and Manufacturing, ensuring robust, scalable, and cost-effective reagent production.This leader will drive process industrialization, establish high-performing supplier networks, and implement operational rigor through quality systems and in-process controls to enable consistent product performance and reliable supply.ResponsibilitiesPartner with R&D to transition reagent formulations and processes from development into robust, repeatable manufacturing processesLead process characterization, scale-up, and transfer to internal pilot manufacturing and external CMOsDefine critical process parameters (CPPs) and critical quality attributes (CQAs)Establish Design for Manufacturability (DFM) and Design for Supply Chain (DFSC) principles early in developmentOwn process validation strategy (IQ/OQ/PQ where applicable, RUO-appropriate rigor)Build and optimize reagent manufacturing workflows for; yield improvement, cycle time reduction, cost of goods (COGS) reduction, throughput scalabilityImplement lean manufacturing and continuous improvement (CI) methodologiesDrive electronic batch record (EBR) adoption and standardized work instructionsDefine and monitor KPIs: yield, scrap, batch success rate, OTIF, cycle timeDevelop and manage a network of strategic suppliers and contract manufacturers (CMOs)Lead supplier selection, qualification, and performance managementDrive suppliers to meet targets for; cost, quality, and lead time/responsivenessImplement supplier scorecards, business reviews, and continuous improvement plansPartner with Quality on supplier audits and qualification (ISO-aligned where applicable)Ensure full compliance with Quality Management System (QMS) requirements including; document control, change control, non-conformance (NCR), CAPA, and supplier qualityEmbed quality at the source through; in-process QC checks, incoming inspection strategies, final release criteriaDrive strong linkage between quality metrics and operational performanceLead root cause analysis (RCA) and implement sustainable corrective actionsEstablish traceability frameworks (lot tracking, genealogy, cold chain integrity)Serve as the operational bridge between, R&D, quality and regulatory, supply chain, manufacturing, and service/field supportLead reagent readiness for product launches and scale-up phasesProvide executive-level visibility into risks, bottlenecks, and mitigation plansRequirementsDeep experience in reagent/process development and scale-up (NGS, proteomics, antibodies, or similar life science products preferred)Strong understanding of process transfer methodologies, DOE / process characterization, manufacturing workflows for biological/chemical reagentsProven experience with contract manufacturing and supplier developmentStrong working knowledge of quality systems (QMS, CAPA, change control, validation) and GMP-lite / RUO environments (with ability to scale toward regulated environments)Experience implementing in-process controls, QC strategies tied to product performance, traceability systems10+ years of experience in biotech/diagnostics/manufacturing operationsDemonstrated success scaling products from R&D ? pilot ? commercial manufacturingStrong analytical and data-driven decision-making skillsProven ability to lead cross-functional teams and influence without authorityCompensation Range: $189K - $252KJ-18808-Ljbffr