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Senior External Manufacturing Specialist

Company: CRISPR Therapeutics
Location: Cambridge
Posted on: May 14, 2022

Job Description:

Job DescriptionCompany 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 Senior Specialist in the External Manufacturing Group at CRISPR Therapeutics is a subject matter expert supporting our clinical GMP manufacturing operations supporting our allogeneic CAR-T and critical component manufacturing processes at contract manufacturing organizations (CMOs). Supports the implementation of manufacturing processes, owns and drives manufacturing quality system records (deviations/CAPA/change controls/risk assessments) and continuous improvement initiatives to closure to support and improve GMP manufacturing success. Compiles manufacturing data to support operational performance and deviation investigations as required. Candidates with experience with cell therapy manufacturing, risk management, root cause analysis, investigation methodologies, change control systems, quality engineering and related QA documentation is a plus.Responsibilities

  • Manage deviations, change controls, risk assessments and CAPAs as required. Partner with Quality and other SMEs to address these issues effectively and compliantly.
  • Conduct document revisions and/or document management including batch records and departmental procedures
  • Follow-up on requests, issues, and projects and report statuses to manager/ working teams
  • Compile manufacturing data to support metric trending to support department KPIs and metrics
  • Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion in a fast paced environment.
  • Enable the successful technology transfer, improvement projects, and operations at the CMO facility, partnering with Quality, Supply Chain and MSAT
  • Support CMO site leads with the coordination of external manufacturing activities at CMO sites, including but not limited to scheduling of batches, supply of materials, providing direction on shipment of material, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide technical expertise.
  • Coordination of critical material specification updates
  • Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
  • Providing on and off-hour support to manufacturing as required.
  • Support tech transfer activities as appropriate.
  • Review CMO documentation in a timely and effective fashion including executed MBRs, sampling plans, milestone reports, investigation/incident documentation, change control documentation and others to enable successful manufacturing of CRISPR's product portfolio.
  • Provide leadership during technical troubleshooting of manufacturing and testing issues at CMOs. This will require strong experience in root cause analysis and risk assessments.
  • Interface with Process Development, Analytical Development, and MSAT teams to understand process operations and key processing steps to provide GMP manufacturing support at CMOs.
  • Be a champion of a highly collaborate, transparent, data driven, ‘make it happen', culture.Minimum Qualifications
    • BS/BA (science preferred) and 5+ years of experience in a cGMP biopharmaceutical/manufacturing environment
    • Knowledge of cell and gene therapy and/or biologics process development and manufacturing with tech transfer, scale-up and clinical/commercial manufacturing.
    • Knowledge of GMP, aseptic processing
    • Experience in working with CDMOs and third parties for process development and cGMP manufacturing preferred.
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
    • Ability to execute project timelines and follow-through to completion, including diligent follow up on action items/next steps, removing barriers, communicating risks, etc.
    • Self-driven, independently motivated, data driven and excellent problem-solving ability.
    • Ability to travel to CMO sites occasionally as requiredCRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.To view our Privacy Statement, please click the following link: by JazzHRuY6DVz3Pcm

Keywords: CRISPR Therapeutics, Cambridge , Senior External Manufacturing Specialist, Other , Cambridge, Massachusetts

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