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Director, Site Quality Control

Company: CRISPR Therapeutics
Location: Framingham
Posted on: January 12, 2021

Job Description:

Company OverviewAt CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases.Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases ---thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.Job SummaryThe Director of Quality Control will lead a Site QC Department supporting Facility commissioning, GMP manufacture, and drug product release testing in a new CRISPR facility under construction in Framingham, MA. This position reports to the Corporate Head of Quality; is a high visibility, high impact position requiring concurrent strategic and tactical contributions.ResponsibilitiesDuring the facility completion stage, as part of the Site Management Team, this position is responsible for: Build-out of a QC function including leading Instrument IQ/OQs and Analytical Methods transfer, qualification, and validationHiring and on-boarding QC personnel including managers and analysts per recruitment planLeading development of Policies, SOPs, and Test Methods required for operation of a QC laboratoryImplementing an electronic Data Management SystemUpon completion of facility qualification, this position is responsible for: Phase appropriate Qualification and Validation of Analytical MethodsBio-Analytical testing of raw materials, process intermediates, and drug productManagement of Reference Standards and Sample managementData management, trending, Data IntegrityOversight of laboratory investigations, OOS, and Change ControlIssuance of QC batch Certificate of AnalysisDeveloping curricula for training analystsFacility Environmental MonitoringPerforming Quality Metrics and annual report reviewsMaintaining the QC function in state of compliance and Inspection readinessMinimum QualificationsTechnical Qualifications:Ph.D. in Biological/Analytical Sciences with a minimum of ten years, or B.S./M.S. with fifteen years, of experience in GMP Quality ControlIn-depth knowledge of FDA/EMA/ICH regulations and guidelines; pertaining particularly to Gene Therapy/Gene Editing drug development platformsExpertise in Gene Editing Analytical Methods ranging from molecular biology, cell biology, flow cytometry, biochemical, and biophysical assaysExperience in management of Reference Standards/Sample/Data management and Stability studiesExperience in drafting study protocols, reports, and compliance documentsLeadership Qualifications:Solid organizational, staff mentorship, and time management skills with attention to detailProven ability to negotiate, influence, and work in a matrix environmentHandling multiple assignments in a fast-paced environment with changing prioritiesIndependent development and execution of plans with minimal supervisionStrong analytical, problem solving, and critical thinking skills. Excellent written and oral communication skillsPreferred QualificationsGene Therapy / Gene Editing drug development/commercializationBuilding a QC functionHealth Agency pre-approval inspectionsUse of statistical software (e.g., JMP, SoftMax Pro, Gen5) to establish specificationsEnvironmental MonitoringWorking with Contract GMP testing laboratories and vendorsAuthoring IND, BLA or equivalent regulatory filingsSummaryLocation: Framingham, MA, United StatesType: Full TimeExperience: Senior Manager/SupervisorDepartment: Quality

Keywords: CRISPR Therapeutics, Framingham , Director, Site Quality Control, Executive , Framingham, Massachusetts

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