Philadelphia, PA

 

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (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. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

 

About the Position

We are seeking a talented and experienced Associated Scientist/Scientist with experience in analytical method development and validation, as well as a strong understanding of tech transfer processes of analytics to CDMO partners.  Reporting to Principal Scientist, Analytical Development, the primary responsibilities of this position include planning and implementation the technology transfer, analytical oversight and assurance of consistent method performance, and investigation and resolution of deviation, for the characterization, quality control, and stability assessment of drug substance intermediates (e.g. lentiviral vector) and drug product analysis at external CDMOs.

 

Responsibilities:

• Participate in evaluation and implementation of new analytical technologies and partners.
• Manage the technology transfer effort of analytical methods to CDMOs. Draft and execute a method transfer plan, review method transfer qualification protocol and data to ensure seamless integration and reproducibility of methods in different laboratory settings.
• Assist in reviewing and approving analytical data, reports, and documentation generated by CDMOs. Ensure accuracy, compliance, and adherence to established protocols and procedures that comply with relevant regulatory guidelines and industry best practices.
• Act as a subject matter expert to identify and troubleshoot analytical issues during tech transfer, propose and implement appropriate solutions to ensure project timelines are met.
• Perform assays for in-process and final lentiviral vector product, CART cells and CAAR T cells.
• Assist in development, optimization, and qualification of analytical methods for the analysis of drug substances intermediates and drug products.
• Assist to author method development and validation report and other technical documents for technical correctness and regulatory compliance.
• Collaborate with regulatory affairs and quality teams to ensure analytical data and documentation meet the requirements of regulatory submissions and inspections.

 

 

Qualifications:

• A bachelor’s degree with 3-5 years’ experience or master's degree with 1-2 years’ experience in relevant science discipline, with 2-5+ years’ experience with tech transfer processes, including documentation, communication, and troubleshooting.
• Strong background in development, optimization, and qualification of analytical methods.
• Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously.
• Detail-oriented with strong problem-solving abilities and a proactive approach to overcoming challenges.
• Familiarity with relevant regulatory guidelines and industry best practices (e.g., ICH, FDA, EMA) for analytical method development and qualification.
• In-depth knowledge of analytical techniques, instruments, and technologies commonly used in gene-modified cell therapy products.
• Excellent communication skills, both written and verbal, with the ability to effectively collaborate with cross-functional teams and present technical information to various audiences.
• Strong team orientation and passion for continuous self-development.
• Experience in the biotech industry or in a startup 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.

 

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.