Position Summary:

The Senior Reagent Manufacturing Engineer will play a crucial role in supporting Reagent and Consumable manufacturing for Vizgen’s MERFISH spatial transcriptomics technology. Working closely with the cross functional operations and development teams, the Senior Engineer will provide advanced technical support for reagent manufacturing processes, characterize and develop manufacturing processes, conduct process verification/validation, and support new product transfers across Vizgen’s portfolio of reagents and consumables.

Responsibilities:

• Lead continuous improvement projects and programs focused on improving reagent quality, characterization, and cost reductions targets.
• Strong technical expertise in process design, equipment selection, and process optimization for reagent product manufacturing.
• Define and develop validation/qualification processes (IQ, OQ, TMV, CSV, PQ) and protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports.
• Ensure compliance with quality systems, including material dispositions, change order implementation, nonconforming evaluations, and CAPAs.
• Identify and implement Lean manufacturing improvements in workflows, processes, and production.
• Support and maintain custom tools developed in house with system integrations and improvements to hardware and software.
• Conduct root cause analysis during investigations for deviations and nonconformities.
• Drive efforts at establishing an equipment management program.
• Own Operations technical support during product launches and transfer of projects from development to manufacturing. Support and drive completion of reagent BOMs, routings, work instructions, batch records, standard production costs, and packaging improvements

Requirements and Qualifications:

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or Biochemistry background + 6+ years of industry experience in a biotechnology or life sciences company or MS + 4 years. Equivalent combination of education and experience may be accepted in lieu of any required degree.
• Strong technical expertise in process design, equipment selection, and process optimization for reagent product manufacturing.
• Demonstrated strong leadership, development, interpersonal, influencing and communication skills, and ability in leading, developing and managing cross-functional teams.
• Experience working with genomics platforms and regent consumable products.
• Excellent communication and collaboration skills to work cross-functionally with internal and external colleagues and customers from various disciplines.
• Experience setting up business processes or programs desired but not required. This could include SPC, Equipment Management, calibration programs, etc.
• Team player that can work with all levels of the organization.
• Strong preference for experience in regulated environments (FDA, IVD, LDT, ISO, etc.) and owning and driving NCRs, CAPAs, and other QMS deliverables.
• Experience working NGS reagents or consumables production facilities or chemistries.