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Reagent Manufacturing Engineer

Cambridge, MA · Biotech/Pharmaceutical
About Vizgen:
Vizgen is a rapidly growing company commercializing the next generation of spatially resolved genomic profiling tools that enable researchers to gain new insight into the biological systems that underlie human health and disease. The company's groundbreaking MERSCOPE product utilizes MERFISH spatial transcriptomics technology to image RNA molecules with high accuracy and unrivaled detection efficiency at subcellular resolution. MERFISH provides transformative insight into a wide range of tissue-scale basic research and translational medicine in oncology, immunology, neuroscience, infectious disease, developmental biology, and regenerative medicine. For more information, go to www.vizgen.com
 
Position Summary:
Working closely with our Reagent Development Team, this Reagent Manufacturing Engineer will be responsible for providing technical support to the reagent manufacturing processes in support of Vizgen’s MERFISH spatial transcriptomics technology. This Reagent Manufacturing Engineer will develop and optimize manufacturing processes, perform process verification/validation, and will support new product transfer of reagents and consumables across Vizgen’s product portfolio.

Responsibilities:
  • In conjunction with Vizgen’s product development team, support new product introduction by finalizing reagent BOM’s, routings, work instructions, batch records and standard production costs.
  • Assist with QC method development/gauge R&R/guard-band studies
  • Validate manufacturing processes to Six Sigma level for consistent production
  • Finalize and validate kit packaging
  • Develop optimum production line layout for quality, efficiency, and throughput.
  • Establish and maintain equipment calibration program
  • Develop manufacturing fixturing for consistent production
  • Implement SPC (in conjunction with Data Analytics team)
  • Identify, evaluate and validate filling automation
  • Address reagent manufacturing issues as they arise in production
  • Identify and implement changes for improved Lean manufacturing, including opportunities for improved workflows, process scale-up, and production automation
  • Support quality system compliance including material dispositions, change order implementation, and nonconforming evaluations.
 
Job Qualifications:
  • A bachelor’s or master’s degree in engineering, bioengineering, mechanical/chemical engineering or a closely related discipline and 10+ years of related industry experience.
  • Hands-on experience sourcing and validating filling automation a must
  • Demonstrated ability to develop and validate robust (Six Sigma) manufacturing processes.
  • Experience with SPC and process controls in a reagent production environment.
  • Experience optimizing production workflows implementing Lean improvements.
  • Experience working within regulated environments (FDA, IVD, LDT, ISO, etc.) is strongly preferred.
  • Strong communication and collaborative skills, working with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
  • Strong customer-service orientation.
  
WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Vizgen affords equal employment opportunity to all qualified persons regardless of race, color, religious creed, national origin, age, military status, sexual orientation, disability, genetic information, gender identity, gender expression or gender unless based upon a bona fide occupational qualification.
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