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Director, Site Quality Control

CRISPR Therapeutics

This is a Full-time position in Framingham, MA posted April 6, 2021.

Company OverviewCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform.

CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA.

CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases.

To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc.

CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S.

subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.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