Director, Reagent Operations

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.

Responsibilities

• Partner with R&D to transition reagent formulations and processes from development into robust, repeatable manufacturing processes

• Lead process characterization, scale-up, and transfer to internal pilot manufacturing and external CMOs

• Define critical process parameters (CPPs) and critical quality attributes (CQAs)

• Establish Design for Manufacturability (DFM) and Design for Supply Chain (DFSC) principles early in development

• Own 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 scalability

• Implement lean manufacturing and continuous improvement (CI) methodologies

• Drive electronic batch record (EBR) adoption and standardized work instructions

• Define and monitor KPIs: yield, scrap, batch success rate, OTIF, cycle time

• Develop and manage a network of strategic suppliers and contract manufacturers (CMOs)

• Lead supplier selection, qualification, and performance management

• Drive suppliers to meet targets for; cost, quality, and lead time/responsiveness

• Implement supplier scorecards, business reviews, and continuous improvement plans

• Partner 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 quality

• Embed quality at the source through; in-process QC checks, incoming inspection strategies, final release criteria

• Drive strong linkage between quality metrics and operational performance

• Lead root cause analysis (RCA) and implement sustainable corrective actions

• Establish 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 support

• Lead reagent readiness for product launches and scale-up phases

• Provide executive-level visibility into risks, bottlenecks, and mitigation plans

Requirements

• Deep 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 reagents

• Proven experience with contract manufacturing and supplier development

• Strong 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 systems

• 10+ years of experience in biotech/diagnostics/manufacturing operations

• Demonstrated success scaling products from R&D → pilot → commercial manufacturing

• Strong analytical and data-driven decision-making skills

• Proven ability to lead cross-functional teams and influence without authority