Quality Control Laboratory Specialist

4 days ago


Indianapolis, Indiana, United States Genezen Full time
About Genezen

Genezen is a cutting-edge biotechnology company dedicated to advancing gene therapy and cell therapy clinical trials. We provide process development, produce GMP viral vectors, and offer cell transduction services to support the development of new treatments.

Job Summary

We are seeking a highly skilled Quality Control Laboratory Specialist to join our team in Fishers, Indiana or Lexington, Massachusetts. As a Quality Control Laboratory Specialist, you will be responsible for maintaining lab functions and procedures, performing laboratory techniques related to viral vector production and analytics, and ensuring compliance with cGMP testing guidelines.

Key Responsibilities
  • Order, organize, and maintain lab reagent material stocks
  • Assist with organization and testing of samples
  • Assist with managing outsource sample shipping and receiving
  • Perform hands-on laboratory procedures related to viral vector production and characterization
  • Maintain cGMP documentation of processing activities
  • Perform routine lab maintenance and maintenance of laboratory equipment
  • Train new staff members and fellow hourly employees in designated processes
  • Comply with all established policies, SOPs, and cGMP guidelines
  • Participate actively in SOP establishment and revisions in coordination with supervisor and Quality Assurance
  • Participate in method qualification and validation activities
Requirements
  • Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field
  • 1+ years of relevant industry experience in QC, R&D, product development, or operations
  • Excellent computer, verbal, and written communication skills
  • Experience with laboratory techniques including cell culture, cell-based assays, qPCR, ddPCR, flow cytometry, ELISA, and/or biostatistical analysis
Benefits
  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 9 observed holidays + 1 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Share Appreciation Rights
  • Choice of several healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance
  • Accidental Death & Dismemberment (AD&D) Insurance


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