Quality Control Senior Scientist

3 days ago

Cambridge, United States Garuda Therapeutics Full time

We have an exciting opportunity for an experienced Quality Control (QC) professional to join Garuda Therapeutics at a critical stage in our development as an organization. This position will be based in our Cambridge, MA site, with travel to our Watertown, MA GMP facility from time to time.


Role and Responsibilities:

  • Hands-on support of in-house QC method qualifications following ICH guidelines in support of site testing requirements
  • Responsible for QC testing including flow cytometry, ddPCR, cell count and viability, endotoxin and cell-based assays, potency assays, extensive cell culture and others
  • Support method transfer from Analytical Development to QC Lab for GMP release assays
  • Write stability protocol with QC release methods in GMP laboratories
  • Reference control development and material management for QC Lab, QC laboratory records, reports, logs, and data
  • Support sample management internal and with external partners (contract laboratories and suppliers)
  • Manage authoring of quality systems records such as SOPs, deviations, lab investigations, change controls, CAPAs, validation reports, etc.
  • Write risk assessment, define scope and write Environmental Monitoring Program documents
  • Review and approve methods and procedures, to ensure compliance with Garuda policies and procedures, regulatory guidelines as well as current industry standards
  • Writes technical/investigation reports and reviews and revises standard operating procedures as needed


Qualifications:

  • BS/MS degree in a relevant field is required
  • 5+ years of experience in a GMP Quality Control function within a fast-paced biotech/pharma organization, including hands-on experience with aseptic techniques
  • Experience with analytical test methods used for cell/gene therapy (e.g., flow cytometry, PCR) is required
  • Prior experience with genome sequencing assays is preferred
  • Previous experience with experiment design and execution to support method lifecycle
  • Experience with Environmental Monitoring and microbiological testing is preferred
  • Strong analytical skills and ability to troubleshoot and investigate issues from the testing
  • Critical thinker with the ability to exert influence diplomatically while partnering across functions
  • Handle issues appropriately and with a sense of urgency
  • Possesses a positive, can-do attitude and creatively solves problems

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