Casebia Therapeutics

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

Job Number: 21201

Location: Cambridge, MA

Job Description

Casebia Therapeutics is seeking a Development Associate/ Senior Development Associate, depending on experience,  to join the process development team to develop the manufacturing process for our first gene-edited T-cell products 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 research process and transform it to a robust, scaleable GMP manufacturing process. The candidate will have strong hands-on technical experience in cell culture process development, ideally with some T-cell experience and exposure to T-cell manufacturing. This lab-based position will lead experimental planning/execution, and support technology transfer and establishment in a GMP facility (CMO) for manufacture 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 a key role for driving company success.

Responsibilities

  • Develop experimental plans, execute independently or part of a team, interpret scientific results through appropriate data analysis for experiments to define (unit operations, equipment, hold steps), characterize (control strategy including parameter ranges & in-process controls) and scale-up the manufacturing process to generate gene-edited T-cells
  • Contribute to transfer of the manufacturing process to a CMO and manage process development and manufacturing activities (including completion of process fit exercise, person in plant requirements as needed) leading to successful GMP manufacturing
  • Summarize and present scientific data and report progress in functional and cross-functional forums (e.g. CMC team) and act as liaison with the research teams
  • Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports
  • Author and/or review process documentation including study protocols, reports, SOPs, batch records, material and product specifications, forms, deviation support documents
  • Support and contribute to relevant and impactful innovation programs to enhance T-cell manufacturing technologies/ capabilities and work-processes

Required Skills

  • B.S./ M.S. in a relevant scientific discipline (e.g. Biological, Biomedical, or Chemical Engineering, Cell Biology, Biology) with 3-5 years relevant experience (industry preferred)
  • Strong knowledge and hands-on experience with mammalian cell culture and manufacturing process development for biological products (cell therapy, viral vaccines etc.)
  • Experience with technology transfer and managing work with external partners and contract organizations for GMP clinical supply manufacture
  • Experience working with viral vectors for gene delivery and/or various gene editing techniques is required
  • Working knowledge of analytical instrumentation/methods employed for cell characterization (e.g. FACS, qPCR)
  • Strong interpersonal skills including verbal and written communication 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

  • Experience working with T-cells or other primary cultures/ stem cells
  • Hands on experience with development and/or clinical manufacture of cell therapies
  • Experience in media development, disposable processing technologies and automation of manufacturing processes

 

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