Senior QC Analyst, Flow Cytometry

Company: CRISPR Therapeutics
Location: Framingham
Posted on: May 27, 2023

Job Description:

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 partnerships 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 in -Boston, -Massachusetts -and -San Francisco, California, and business offices in -London, -United Kingdom.Position SummaryOur QC team is looking for an enthusiastic individual to work at our state-of-the-art manufacturing facility in Framingham, MA. The Senior QC Analyst is a valuable member of the Quality Control-Bioanalytical team that will coordinate and perform in-process and final product testing of novel cell-based drug therapies and AAV products. The successful candidate will perform flow cytometry assays as well as various biochemical, biophysical, molecular biology, and compendial tests in a GMP environment. In addition, the QC Analyst will lead analytical method transfer and validation projects. The QC Analyst-Flow Cytometry reports to the QC Bioanalytical Sr. Manager.Responsibilities

• Support the transfer and validation of analytical methods to the Framingham facility.
• Performs routine in-process and final release testing of cell therapies and AAV products.
• Conduct raw material inspection and release per approved SOPs.
• Assemble raw material data packages for release.
• Complete and compiles all documentation and perform data review for compliance and product release.
• Assist with the data review for compliance and product release, and generation of product COAs.
• Author, review and approve SOPs, protocols, and reports.
• Lead and/or support QC investigations, OOS, deviations, and CAPA implementation.
• Perform maintenance of QC equipment.
• Assists in the implementation of the Laboratory Information Management System.
• Contribute to establish a reference standard program and sample management system.
• Perform other related duties based on business needs.Minimum Qualifications
  • Minimum of bachelor's degree in biochemistry or related scientific field.
  • Minimum of two years of experience in flow cytometry, preferable in a QC environment.
  • Previous experience with multi-color flow cytometry, and other analytical methods such as PCR, ELISA, Western blot, and compendial methods.
  • Excellent communication skills, technical writing, and detail oriented.
  • Good at managing time and priorities.Preferred Qualifications
    • Experience with cell culture, aseptic techniques, and raw material qualification, preferred.
    • Direct experience with analytical method validations and/or transfers, preferred.Competencies
      • Collaborative - Openness, One Team
      • Undaunted - Fearless, Can-do attitude
      • Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
      • Entrepreneurial Spirit - Proactive. Ownership mindset.CRISPR 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.
        
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Keywords: CRISPR Therapeutics, Framingham , Senior QC Analyst, Flow Cytometry, Professions , Framingham, Massachusetts