Manager, Reagent Manufacturing

Nautilus Biotechnology•San Carlos, CA

1d•$111,000 - $162,000•Onsite

About The Position

Nautilus is hiring a Manager, Reagent Manufacturing to lead day-to-day reagent production as the company scales internal manufacturing for its next-generation proteomics platform. The manager will supervise, coach, and develop manufacturing associates and specialists while remaining hands-on in the laboratory running complex bioconjugation processes. The role sets production priorities, leads scale-up and process improvement projects, and resolves production issues. It works closely with R&D and NPI scientists to transfer new processes into production, with QC to ensure reagent specifications and functionality are met, and with the commercial team to deliver reagents on time. The position is suited to an experienced reagent manufacturing professional who has led, trained, or supervised others in a production setting and enjoys hands-on laboratory work. The successful candidate brings a quality-first mindset, knowledge of good manufacturing practices and continuous process improvement, and the communication skills to build an accountable, collaborative team and influence across functions. The role is located in San Carlos, California, and requires full-time onsite presence.

Requirements

BS or MS in Biochemistry, Molecular Biology, Chemistry, or a 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, with a strong interest in growing as a people manager.
Hands-on experience with bioconjugation chemistries and protein purification and characterization, such as HPLC, TFF, SEC, PAGE, and ELISA.
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 amid shifting priorities.
Strong data analysis skills and proficiency with Excel and statistical tools such as JMP or R.
Uses data and sound judgment to make decisions, knows when to escalate 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.

Nice To Haves

Experience with proteins, antibodies, DNA, and/or bioconjugates.
Working knowledge of ISO 13485 and 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.

Responsibilities

Supervise, coach, and develop reagent manufacturing associates and specialists; set expectations, provide feedback, support development, and partner with the manager on hiring and performance reviews.
Translate department and company goals into team goals and track progress.
Plan and assign daily and weekly production work, balancing 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.
Promote a safe, quality-first culture and ensure compliance with EHS requirements, good documentation practices, and clean room procedures.
Plan and execute manufacturing builds for antibody and protein bioconjugated complex formulations and buffers, including the most complex or time-critical builds.
Manage reagent processes from R&D technology transfer through pilot lots, scale-up, and routine production.
Lead scale-up and process optimization projects, delegate workstreams, and deliver projects on schedule.
Set up, run, and troubleshoot bioconjugation reactions and purification steps such as HPLC, TFF, and filtration; coach team members in troubleshooting.
Author Master Batch Records, SOPs, Standard Test Procedures, and work instructions; review and approve team documentation and executed batch records.
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, and track them to closure.
Ensure production equipment, including liquid handlers and other automation, is qualified, validated, maintained, and troubleshot.
Drive continuous improvement using lean and 5S principles, and maintain records and the 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 metrics such as on-time delivery, right-first-time builds, and deviations to guide decisions; report status and recommendations and propose changes to team procedures and processes.