Senior/Principal Research Associate, Analytical Development

Position Summary

We are seeking a Senior/Principal Research Associate to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will join the Technical Operations (Tech Ops) group at CRISPR Therapeutics, focusing on development of analytical methods for ex vivo genetically modified cells to support the development of gene editing programs. The individual will develop quantitative assays measuring gene editing in target and non-target cells, cell-based assays measuring the expression and the biological functions of specific genes. The successful candidate will independently design, perform, and analyze experiments for multiple preclinical and clinical programs, and will work independently to support process development, product characterization, and technical transfer to CMOs and GMP test labs.

Responsibilities

  • Develop and qualify quantitative assays measuring gene editing using flow cytometry
  • Develop and qualify cell-based assays measuring gene expression/function, as well as virus infectious titer
  • Work with Process Development to generate and analyze process development data to develop an understanding of cellular product critical quality attributes to guide testing and process control strategies
  • Develop data sets supporting product specification and for qualification and/or validation of cell-based assays at CMOs and GMP test labs
  • Author technical reports on assay development/optimization and SOPs for assay performance
  • Analyze and present experimental data
  • Assess and implement new analytical technologies

Minimum Qualifications

  • MS or BS in life sciences and 6+ years of relevant assay development experience in industry
  • Significant experience of flow cytometry-based assay development for cell analysis
  • Experience in analytical method development, qualification/validation
  • Understanding of assay development and qualification per regulatory guidance (USP, ICH)
  • Hands-on experience in development cell-based assays
  • Excellent oral and written communication skills
  • Experience in tech transfer of assays to QC labs

Preferred Qualifications

  • Experience with assay development for immunology or immuno-oncology products
  • Experience in assay development for cell and gene therapy products
  • Experience in development of cell-based potency assays

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.

If interested and qualified, please include Requisition # 2018-401 in the subject line when emailing resume to: careers@crisprtx.com.

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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Requisition # 2018-401

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