Director, Reagent Operations
About The Position
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.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
