Job Title: Scientist/Senior Scientist, T-Cell Therapy Analytical Sciences
Job Number: 19219
Location: Cambridge, MA
Casebia Therapeutics is seeking a Scientist/Senior Scientist 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 manufacturing process. The candidate will have a strong background in immunology and 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 position includes both lab and management responsibilities and will participate in analytical development strategy and lead experimental planning/execution, 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 a key role for driving company success.
- Manage analytical development hands-on for gene-edited ex vivo T-cell therapy products for structural and functional characterization of products to be used in the clinic.
- 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
- Summarize and present scientific data and report progress on behalf of the team in cross-functional forums (e.g. CMC team) and liaison with the research teams
- Lead definition of the quality target product profile working with stakeholders in discovery, pre-clinical, and translational functions and use to develop critical quality attributes for product
- Contribute to development of assays on the drug product that can predict safety and efficacy outcomes considering input material variability etc.
- Contribute to CMC teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups
- 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.
- Assist in the development of standard operating procedures, analytical test methods, analytical sampling plans involving immunoassays, and molecular biology techniques
- Author and/or review process documentation including study protocols, reports, SOPs, batch records, material and product specifications, forms and deviation support documents
- Contribute to regulatory interactions and filings and responses to regulatory questions
- Support and contribute to relevant and impactful innovation programs to enhance T-cell analytical technologies in the areas of cell phenotyping, potency measurement, sorting technologies to characterize sub-populations, single cell approaches, aligned with emerging business drivers and regulatory expectations
- Hires, trains, supervises and mentors junior staff members
- PhD in a relevant scientific discipline (e.g. Immunology, Molecular Biology, Cell Biology, Biology) with 3-5 years relevant experience, including experience in industry
- Strong foundational knowledge in immunology and hands-on experience with T-cells or similar cell types
- Analytical method development and qualification experience in molecular biology and cell biology techniques for cell characterization such as quantitative PCR (qPCR), immunoassay, and flow cytometry
- Demonstrate a strong skill set and knowledge in analytical assay development and assay optimization. Understanding and experience of analytical assay validation is a plus
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, analytical method development, technology transfer, method qualification/validation, and process development
- Experience with assay transfer and managing work with external partners and contract organizations in a GMP compliant setting
- Previous experience managing/mentoring associate scientists in a laboratory setting is a preferred.
- Experience working with viral vectors for gene delivery and/or various gene editing techniques
- Demonstrated scientific aptitude through authorship of peer-reviewed publications
- Ability to manage priorities, influence without authority, and drive to decisions in a fast-paced environment to achieve deliverables in a timely fashion
- Strong interpersonal skills including verbal and written communication skills are essential in this collaborative work environment
- Ability to collaborate effectively in a team-oriented environment; driven and highly organized
- Willingness to travel approximately 20% of the time to engage with R&D teams and external CMOs.
Preferred Skills & Qualifications
- Experience in developing and executing cellular characterization assays with cell therapy products, including T cells, is a plus
- Experience authoring sections of regulatory documents preferred.
- Awareness of GMP manufacturing environment for cell therapy products, including closed-systems, single-use / disposable technology, sterile / aseptic processing, and process qualification
- Awareness of GMP and CMC regulations for gene and cell therapy, including Advanced Therapy Medicinal Product (ATMP) regulations