Principal Research Associate, Cell Therapy Process Development

Crispr Therapeutics AG Cambridge , MA 02138

Posted 2 months ago

Company Overview

At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.

We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases

Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases -thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

Job Summary

If you like a challenge, love to learn and want to be part of a team developing the next generation of gene editing biotherapeutics based on CRISPR/Cas9, we would like to hear from you. Our ideal candidate will have hands-on technical experience with upstream process development for the manufacture of biologics and will have a solid understanding of bioprocess engineering principles. The position will be responsible for upstream cell culture of recombinant viruses and will be a key member of the team developing viral vector manufacturing processes for novel gene editing/gene therapy vectors.

Job Responsibilities:

We are looking for a Principal Research Associate to join the Process Development Group at CRISPR Therapeutics. Successful candidates will be integral to develop, optimize and qualify cellular processes for cell and gene therapy. Cell culture and cell analysis skills are required for this position. Candidates with enthusiasm, passion, and a desire to create important new medicines for patients are highly favorable.

Responsibilities of the Principal Research Associate, Cell Therapy Process Development (Cell culture, Upstream, Flow Cytometry)

  • Design and execute experiments to establish cellular process parameters and process scale-up activities for early-phase clinical manufacturing;

  • Independently optimize manufacturing processes including cell selection, cell culture, gene editing and gene transfer with electroporation and viral vectors;

  • Perform and analyze in vitro cellular assays such as cell counts and flow cytometry to support in-process analysis for process development studies;

  • Collect, analyze and present experimental data;

  • Maintain clear and complete experiment records;

  • Document development activities in Technical Reports supporting regulatory filings; and,

  • Support drafting and revising protocols and SOPs and regulatory sections and filings (i.e. IND)

Minimum Qualifications of the Principal Research Associate, Cell Therapy Process Development (Cell culture, Upstream, Flow Cytometry)

  • MS in biology or related discipline and 8+ years of relevant research experience;

  • Experience with mammalian cell culture techniques;

  • Experience with multi-color flow cytometry;

  • Excellent oral and written communication skills;

  • Ability to work independently as well as part of a results-oriented team;

  • Highly organized with significant attention to detail;

  • Working knowledge of GXPs and generation/review of GMP documents; and,

  • The ideal candidate enjoys working in a fast-paced environment and breaking new ground in the gene and cell therapy space.

Preferred Qualifications of the Principal Research Associate, Cell Therapy Process Development (Cell culture, Upstream, Flow Cytometry)

  • Experience developing processes for early phase clinical products;

  • Knowledge of Immunology or immune-oncology, especially T cell biology;

  • Experience operating bioreactors (e.g. AMBR), benchtop to 100L-scale;

  • Experience developing processes using single-use disposables;

  • Experience with editing and cell selection technologies for primary human cells; and,

  • Experience with Design of Experiments (DOE) for process development and optimization.

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:

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Principal Research Associate, Cell Therapy Process Development

Crispr Therapeutics AG