Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases, including SLE/lupus nephritis and myositis and which uses a CD-19 binder that has an encouraging clinical tolerability profile. The second strategy is Cabaletta Bio’s proprietary CAART, or chimeric autoantibody receptor T cells, strategy, which is designed to cause antigen-specific B cell depletion of well-defined, disease-causing B cells. Our lead product candidate developed using the CAART strategy is being evaluated in a clinical trial for patients with mucosal pemphigus vulgaris (mPV) and our second product candidate is expected to initiate a clinical trial later this year in muscle-specific tyrosine kinase (MuSK) myasthenia gravis. Cabaletta Bio’s headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and Twitter.
Uniquely Differentiated. Rapid. Elegant.
At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.
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About the position
The Associate Principal Scientist / Principal Scientist, Process Development is responsible for developing, optimizing, and validating processes to manufacture cell-based therapeutics, from early research through clinical trials and commercialization. Key activities for this role will include development of the cellular manufacturing processes (including the next gen), process scale-up, optimization, process characterization, and verification of clinical and commercial manufacturing processes.
- Contribute to the development of early and late-stage clinical manufacturing processes and commercial cell therapy manufacturing processes.
- Evaluate new technologies, develop novel cell therapy approaches, including cell sourcing, expansion, manipulation, and characterization. Contribute to the successful translation of novel cell therapies from early-stage research to clinical applications.
- Serves as a technical lead for process development projects, responsible for experimental design of process development studies, applying Quality by Design principles and Design of Experiment methodologies where appropriate.
- Optimize and scale-up cell culture processes, analyze data, and interpret results, author technical reports and derive standard operating procedures. Define process operating ranges, acceptable ranges for process understanding and performance optimization, perform gap analysis/failure mode effect and analysis (FMEA).
- Contributing to technology transfer, process characterization, process validation, and troubleshooting.
- Demonstrate strong oral and written communication skills, contribute to scientific conferences and presentations to share the knowledge with the broader scientific community.
- Design and implement process monitoring and control strategies, conducting process characterization studies, and identifying critical process parameters to ensure product quality and consistency.
- Collaborate with cross-functional teams, including analytical, pre-clinical, translational, quality assurance and regulatory, to establish robust and scalable manufacturing processes that comply with cGMP and regulatory requirements. Contributes to CMC enabling studies.
- Author and review of technical documentation to support early-stage activities (development reports and supporting documentation for regulatory filings) as well as draft manufacturing documentation to support tech transfer.
- Guide and mentor junior scientists for trouble shooting, deviation investigation, and product impact assessment for projects employing developed technology/processes.
- Contribute to the strategic planning and decision-making related to process development initiatives, ensuring the timeline, budget and quality standards are met
- Maintain accurate and detailed laboratory notebook (including electronic notebook), summarize and present data in group and cross-functional meetings.
- Ph.D. in Biological Sciences or related fields with 4+ years’ experience (Associate Principal Scientist) or 6+ years (Principal Scientist) working within biologics process development and manufacturing under cGMP processes, or masters with 6-7 years of relevant experience, bachelors with 8-10 years relevant experience.
- Experience and working knowledge of T-cells or immunological cell therapies are required.
- Biotech industry experience supporting allogeneic and /or autologous cell therapy process development/process scale-up /optimization/manufacturing; experience with process characterization and late-stage development is highly desirable.
- SME for process development and process instrumentation engineering activities including, but not limited to, target cell isolation platforms, automated cell washing, electroporation systems, culture expansion, cryopreservation.
- Experience with functionally closed systems or early technology evaluations for large-scale autologous or allogenic CAR-T cell processing is highly desirable.
- Experience with and knowledge of analytical methods used in the characterization and understanding of cell therapy products. Flow cytometry experience is highly desired.
- Experience with non-viral gene editing techniques (e.g., CRISPR) in primary T cells with instrumentation and methods that can be implemented in manufacturing is a plus.
- Good working knowledge of cGMP manufacturing of biological process and ICH regulations. Experience drafting manufacturing documentation and supporting documentation for regulatory filings is strongly desired. Experience with clinical phase appropriate regulatory requirements in manufacturing from early to registrational trials is a plus.
- Demonstrated ability for critical thinking and innovation, able to understand and communicate risks, and develop and execute contingency plans.
- Experience leading a team as a strong scientific leader, reviewing and interpreting the collective data sets and troubleshooting.
- Ability to develop strong partnerships as part of a team and work collaboratively with cross-functional groups, including members of the CMC, Preclinical, Discovery teams, and project management, to meet project deliverables.
- Ability to coordinate and prioritize parallel tasks across multiple projects. Highly organized and efficient, able to work independently.
- Strong problem-solving skills are required. Project management experience is a plus.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Strong team orientation and passion for continuous self-development.
- Detail-oriented with excellent problem-solving, technical writing and verbal communication skills.
- Strong team orientation and passion for continuous self-development.
- Experience in industry or in ap industrial setting is preferred.
Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.
For more information, please visit https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.