Manager, Reagent Manufacturing

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 deep, hard science with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines.

We are hiring for a Manager, Reagent Manufacturing to join our growing team. As we scale internal reagent production for our next generation proteomics platform, this role will lead the reagent manufacturing team day to day – supervising, coaching, and developing a team of manufacturing associates and specialists while staying hands-on at the bench running complex bioconjugation processes. You will set the team’s production priorities, lead scale-up and process improvement projects, and act as the go-to problem solver for production issues. You will work closely with R&D and NPI scientists to bring new reagent processes into production, with QC to ensure specifications and functionality are met, and with the commercial team to deliver reagents on time.

Ideal candidates are player-coaches: experienced reagent manufacturing professionals who have led, trained, or supervised others in a production setting and still enjoy hands-on lab work. You bring a quality-first mindset, a strong grasp of good manufacturing practices and continuous process improvement, and the communication skills to build an accountable, collaborative team and influence across functions. The position is located in San Carlos, CA and requires full-time onsite presence.

Responsibilities

• Supervise a team of reagent manufacturing associates and specialists – setting clear expectations, holding the team accountable, giving regular feedback and coaching, and supporting each person’s development; partner with your manager on hiring and performance reviews

• Work with your manager to translate department and company goals into team goals, and regularly track the team’s progress against them

• Plan and assign daily and weekly production work across the team, balancing build schedules, staffing, and equipment availability to meet commercial and internal demand

• Train team members on bioconjugation processes, SOPs, equipment, and good manufacturing practices; maintain training records and ensure staff are qualified on the processes they run

• Foster a safe, quality-first team culture; ensure the team follows EHS requirements, good documentation practices, and clean room procedures

• Stay hands-on in the lab: plan and execute manufacturing builds for antibody and protein bioconjugated complex formulations and buffers used on the Nautilus platform, and step in on the most complex or time-critical builds

• Own reagent processes end to end – from technology transfer out of R&D through pilot lots, scale-up, and routine production

• Lead scale-up and process optimization projects; break complex problems into manageable workstreams, delegate across the team, and drive them to completion on schedule

• Set up, run, and troubleshoot bioconjugation reactions and associated purification steps (e.g., HPLC, TFF, filtration), and coach team members through troubleshooting

• Author Master Batch Records, SOPs, Standard Test Procedures, and work instructions; review and approve documentation and executed batch records from the team for accuracy and completeness

• Partner with R&D and QC to define and refine in-process and release specifications, analytical and functional tests, and acceptance criteria for raw materials and finished reagents

• Lead investigations of failed or out-of-specification builds; perform root cause analysis, assign corrective and preventive actions (CAPA), and track them to closure

• Ensure production equipment, including liquid handlers and other automation, is qualified, validated, maintained, and troubleshot

• Drive continuous improvement in the production area using lean and 5S principles; maintain records and clean room environment in compliance with good manufacturing practices

• Oversee reagent inventory, material planning, and ordering using ERP/LIMS systems to prevent supply interruptions

• Use production data and metrics (e.g., on-time delivery, right-first-time builds, deviations) to drive team decisions; report status and recommendations to your manager, R&D, and Applications teams, and recommend changes to team procedures and processes

Requirements

• BS/MS in Biochemistry, Molecular Biology, Chemistry, or related field

• 5-7+ years of hands-on experience in reagent production or life science reagent manufacturing (or 4+ years with an MS), including experience leading or training others as a team lead, shift lead, or supervisor

• Experience training and coaching technical staff, and a strong interest in growing as a people manager

• Hands-on experience with bioconjugation chemistries and protein purification and characterization (e.g., HPLC, TFF, SEC, PAGE, ELISA)

• Proven track record authoring and reviewing batch records, SOPs, and test procedures in a regulated or quality-driven environment

• Experience leading troubleshooting, root cause analysis, quality investigations, and CAPA

• Experience scheduling production and managing team workload against shifting priorities

• Strong data analysis skills; proficiency with Excel and statistical tools (JMP, R, or similar)

• Uses data and good judgment to make decisions, knows when to escalate in ambiguous or complex situations, and manages multiple priorities as business needs change

• Excellent written and verbal communication skills, including giving clear, specific feedback and presenting technical information to peers and cross-functional groups in a way that is easy to digest

Preferred Qualifications

• Experience with protein, antibodies, DNA, and/or bioconjugates

• Working knowledge of ISO 13485 / GMP standards

• Prior experience as a formal people manager or supervisor in a manufacturing environment

• Experience with ERP, PLM, and LIMS systems

• Experience supporting technology transfer to contract manufacturers

• Strong understanding of lean manufacturing and 5S principles

Nautilus Team Culture

• We are curious go-getters: this is a team of life-long learners who aren’t afraid to tackle the big challenges and we embrace the journey

• We are detail oriented: we do great science by working smart & with diligence where we learn from our trials and mistakes

• We are easy to work with: we want our workplace to be one where everyone can share their perspective and be treated with respect and kindness

Our Values:

• Be Excellent

• Be a Good Human

• Catalyze Customer Success

• Dream Big

• Drive for Results

• Enjoy the Voyage

• Succeed as One Team