Senior Quality Control Analyst, Flow Cytometry

Company: CRISPR Therapeutics
Location: Framingham
Posted on: August 2, 2022

Job Description:

Company Overview

CRISPR 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 Boston, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

Job Summary

Our 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.
  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.
  • Experience with cell culture, aseptic techniques and raw material qualification, preferred.
  • Direct experience with analytical method validations and/or transfers, preferred.
  • Excellent communication skills, technical writing, and detail oriented.
  • Good at managing time and priorities.
    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.
    
    To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Keywords: CRISPR Therapeutics, Framingham , Senior Quality Control Analyst, Flow Cytometry, Professions , Framingham, Massachusetts