Senior Manufacturing Biochemist (Reagents)

  • South Bend, IN
  • Direct Hire
  • Job ID: OH170-2687609

$1 to $1 Per Year

Senior Manufacturing Biochemist (Reagents)

South Bend, IN Area (Relocation Assistance Provided)

World class medical manufacturing facility is growing rapidly and advancing and has an immediate need for a Senior Biochemist. We are looking for an experienced professional who could climb the ranks (will be the successor to the Manager), and lead troubleshooting efforts of complex problems (manufacturing of reagents). This is a 24/7 facility,  high volume, double-digit millions & billions of product produced annually – highly automated, robotic facility! Very stable work environment, low turnover. 


Key areas:

  • Lead complex troubleshooting and support manufacturing and supplier issues for reagent manufacturing (identifying issues, designing complex experiments, and proposing resolutions)
  • Strength in bench scale solution preparation and specialized testing techniques
  • Analyze, interpret and present data for review; summarize results
  • Write & execute validation and verification plans to ensure project completion within time
  • Lead root cause analysis investigations and drive implementation of solutions
  • Technical support for OEM product/process investigations and improvements (and customer complaints)
  • Identify & implement process and equipment improvements (capabilities, reduced cost, increased quality)
  • Lead cross functional manufacturing support teams and mentor junior biochemists


Desired Qualifications:

  • Bachelor’s Degree required; Masters desired (Chemistry or Science/Engineering)
  • 4+ years experience working in technical operations; biochemistry.
  • Experience with reagent manufacturing strongly desired; but knowledge of clinical chemistry, immunoassay, analytical chemistry, biostatistics or manufacturing process capability in a medical facility will be considered
  • Strong root cause analysis and manufacturing resolution/design issue experience
  • Experimental design/data interpretation
  • Statistical knowledge to develop sampling plans and analyze data
  • Ability to prepare data analysis reports and testing protocols
  • Must be well versed in Office Applications, particularly Excel and Access; experience in Matlab, SAS, or Minitab desired.
  • Very organized, detail-oriented
  • Highly self-motivated
  • Able to work independently
  • Must be US Citizen/Perm Resident, No Visa Sponsorship currently.
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