Operations Manager, Consumables & Reagents

VedaBio is developing a next-generation, amplification-free molecular detection platform for point-of-care diagnostics. Our technology integrates CRISPR-driven detection with novel sample-to-answer workflows on a fully-automated system – instrument, single-use consumables, and customer-facing software. Both the chemistry and the instrument platform are under active development as we enter a major product development push.

As VedaBio moves from prototyping into development and commercialization, manufacturing is a core capability and key to our success. We are a fast-paced, execution-focused startup building systems designed to scale from day one.

Role Overview

The Operations Manager, Consumables & Reagents owns day-to-day reagent and component operations across sourcing inputs, incoming QC, stability, inventory, and current-state cartridge assembly. This is a hands-on role responsible for translating proof-of-concept R&D builds into reliable, scalable operations and ensuring on-time material readiness. This role will operate in close coordination with Manufacturing Engineering, Quality, and R&D.

Key Responsibilities

Formulation & Productization

• Partner with R&D to stress-test formulations against material and environmental variabilities, including shelf-life and shipping requirements
• Design and execute QC methods for all material release from manufacturing
• Establish lot-to-lot comparability and acceptance criteria
• Design and run stability studies (real-time, accelerated)

Scale-Up & Manufacturing

• Own operational readiness for builds, including material availability, WIP, and build execution. This includes inventory strategy, forecasting, and the kanban system.
• Partner closely with the Director of Manufacturing Engineering to translate development-stage builds into scalable manufacturing workflows
• Support process characterization, troubleshooting, and operational improvements to drive down process time and improve yield
• Serve as the operational interface with CDMOs and manufacturing partners for reagent and component readiness

Systems & Quality Execution

• Lead process documentation development and execution
• Execute within design control frameworks (methods, data, traceability)
• Support non-conformance investigations and CAPA implementation
• Provide operational data to support process changes, as well as regulatory and validation activities

Team Building

• Hire and develop a small operations team as demand increases

Required Qualifications

• BS/MS in biochemistry, molecular biology, chemical engineering, or related field
• 5–10+ years in reagent operations, life sciences manufacturing, or related roles
• Experience scaling processes from early-stage development into high-volume
• Hands-on experience with QC systems and variability management
• Familiarity with regulated environments (IVD, CLIA, ISO 13485)
• Strong data-visualization and presentation skills to champion process changes
• Experience with molecular assay systems (e.g., CRISPR, PCR, isothermal amplification)

Success in Role (6–12 Months)

• Incoming QC and stability systems operational
• Reliable material readiness and inventory systems in place
• Successful support of tech transfer activities
• Cartridge assembly running with defined processes and yields
• Cost drivers identified with active optimization plan
• Successful operational integration with Manufacturing Engineering to support pilot line readiness and consumable build scalability.