Director, Reagent Operations San Carlos

Director, Reagent Operations San Carlos San Carlos, CA Job Details Full-time $189,000 - $252,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Parental leave Vision insurance Life insurance Qualifications Quality control corrective actions Proteomics Manufacturing management Sourcing Next generation sequencing Certified Professional In Patient Safety Operations management Procedural guides ISO standards Design of manufacturing processes Supplier quality engineering practices Regulatory compliance Engineering process optimization Corrective and preventive actions (CAPA) GMP Risk mitigation strategy implementation Supplier audits Supplier audit compliance assessment Key Performance Indicators Analysis skills Quality control documentation Decision making Performance Improvement (PI) Batch records Quality inspection Design for manufacturability (DFM) Root cause analysis Supplier selection Senior level Document management Cross-functional collaboration Cross-functional team management Research & development Implementing cost-saving initiatives Data-driven decision making Manufacturing company experience Implementing lean manufacturing processes Regulatory compliance management Cross-functional communication Supply chain collaboration Engineering validation New product launch experience Supply chain process improvement 10 years Full Job Description Location San Carlos Employment Type Full time Location Type On-site Department Operations Compensation $189K - $252K • Offers Equity • Offers Bonus The hiring pay range for this position is based on skills, education and experience relevant to the role; title may be assessed one level lower or higher, accordingly. Other components of total compensation include a competitive options grant at the time of hire (with potential for additional grants). Benefits include medical, vision, and dental insurance, group and supplemental life insurance, 401k retirement plan, responsible (unlimited) paid time off, parental leave, and more. 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