Manager, Reagent Manufacturing

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