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 requirementsResponsible for QC testing including flow cytometry, ddPCR, cell count and viability, endotoxin and cell-based assays, potency assays, extensive cell culture and othersSupport method transfer from Analytical Development to QC Lab for GMP release assaysWrite stability protocol with QC release methods in GMP laboratoriesReference control development and material management for QC Lab, QC laboratory records, reports, logs, and dataSupport 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 documentsReview and approve methods and procedures, to ensure compliance with Garuda policies and procedures, regulatory guidelines as well as current industry standardsWrites technical/investigation reports and reviews and revises standard operating procedures as needed Qualifications: BS/MS degree in a relevant field is required5+ years of experience in a GMP Quality Control function within a fast-paced biotech/pharma organization, including hands-on experience with aseptic techniquesExperience with analytical test methods used for cell/gene therapy (e.g., flow cytometry, PCR) is requiredPrior experience with genome sequencing assays is preferredPrevious experience with experiment design and execution to support method lifecycleExperience with Environmental Monitoring and microbiological testing is preferredStrong analytical skills and ability to troubleshoot and investigate issues from the testingCritical thinker with the ability to exert influence diplomatically while partnering across functionsHandle issues appropriately and with a sense of urgencyPossesses a positive, can-do attitude and creatively solves problems