Casebia Therapeutics

Job Title: Development Associate/Senior Development Associate, T-Cell Therapy Analytical Sciences

Job Number: 21200

Location: Cambridge, MA

Job Description

Casebia Therapeutics is seeking a Development Associate/ Senior Development Associate, depending on experience, to join the analytical sciences team to develop and implement analytical methods to characterize our first gene-edited T-cell product(s) to enable life-changing cell therapy for patients.  In this role, you will interact with research groups at Cambridge and San Francisco and our world-leading collaboration partner to innovate at the cutting-edge of CRISPR based editing for ex vivo therapies. You will have an opportunity to learn the existing analytical methods and qualify them for GMP implementation and to develop new methods as needed for the engineered cells from our manufacturing process. The candidate will have hands-on technical experience with development of analytical methods for characterization of cells, preferably in the context of T-cell or stem-cell based therapies. This lab-based position will involve experimental planning/execution, support of technology transfer and establishment in a GMP facility (CMO) for release and characterization of nonclinical and clinical supplies.   This is an exciting opportunity for paving the path to a novel cell therapy with great potential for innovation, professional growth, and for driving company success.

Responsibilities

  • Design and execute method development and qualification in support of process development, product release and stability, product characterization and investigation, for gene-edited T-cells
  • Assist in the development of standard operating procedures, analytical test methods, analytical sampling plans involving immunoassays, and molecular biology techniques
  • Summarize and present scientific data and report progress in functional and/or cross-functional forums (e.g. CMC team) and liaison with the research teams
  • Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports
  • Contribute to transfer of the analytical methods to a CMO and manage implementation and qualification activities leading to successful use of methods in QC to release and characterize GMP T-cell product
  • Author and/or review process documentation including study protocols, reports, SOPs, batch records, material and product specifications, forms and deviation support documents
  • Support and contribute to relevant and impactful innovation programs to enhance T-cell analytical technologies

Required Skills

  • B.S. /M.S. in a relevant scientific discipline (e.g. Immunology, Molecular Biology, Cell Biology, Biology) with 3-5 years relevant experience, preferably in industry
  • Hands-on analytical method development and qualification experience with molecular techniques such as quantitative PCR (qPCR), and immunoassays
  • Prior experience with cell-based assays for product characterization and flow cytometry for cell characterization
  • Prior experience with assay transfer and interactions with external partners and contract organizations in a GMP compliant setting (biopharma industry)
  • Strong interpersonal skills including verbal and written communication skills are essential in this collaborative work environment
  • Willingness to travel approximately 20% of the time to engage with R&D teams and external CMOs

Preferred Skills & Qualifications

  • Working knowledge of viral vectors for gene delivery and/or various gene editing techniques
  • Prior experience working with T-cells or other primary cells
  • Understanding and experience with analytical assay validation

 

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