Associate Scientist, Analytical Development

Associate Scientist Analytical Development On-site Philadelphia PA

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable perhaps curative treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas including rheumatology neurology and dermatology. Cabaletta Bios headquarters and labs are located in Philadelphia PA. For more information please visit and connect with us on LinkedIn.

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 this way we are not only working to improve the lives of patients but of everyone involved. #CabalettaCrew.

Were 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

Position Summary

Reporting to Director Analytical Development this experienced and motivated Associate Scientist will join Analytical Development Team participating in a variety of analytical activities involved in lifecycle method management - method development and qualification analytical testing support for projects at Process Development and CDMOs CDMO testing oversight (assay performance trending troubleshooting/root cause analysis) for pre-clinical and clinical programs.

The successful candidate has opportunities to collaborate closely with CMC Quality & Compliance Supply Chain and external partners.

Responsibilities

• Participate in the development optimization and qualification/validation of analytical methods as required to evaluate safety purity identity potency of lentiviral vectors cell therapy product and other advanced modalities in compliance with relevant regulatory guidelines

• Perform analytical testing supporting method development and qualification activities.
• Participate in technical oversight and serve as subject matter expert (SME) to CDMOs and external laboratories.

• Assist monitoring/trending of assay performance investigation of assay deviations out-of-specification out-of-trend and out-of-expectation results at Analytical Development and external partners.
• Provide analytical expertise to Process Development Manufacturing Sciences and Technology (MSAT) Quality & Compliance and Quality Control

• Author and review method protocols reports and supporting documentation ensuring compliance with GMP GDP and applicable regulatory requirements.

• Present in technical meetings and drive resolution of analytical-related issues.

Qualifications

• Bachelors or masters degree in biology or closely related discipline with 2-4 years of experience.

• Proficient in aseptic techniques for cell culture and cell-based assays.
• Strong experience in analytic techniques including flow cytometry qPCR/dPCR ELISA HPLC etc.
• Demonstrated experience with analytical method qualification and validation.
• Experience working with CDMOs and contract testing laboratories in biologics cell and gene therapy fields.
• Familiar with GMP compliance.

• Demonstrated scientific problem-solving critical-thinking and communication/ interpersonal skills with attention to detail and strong organizational skills and ability to manage multiple priorities in a fast-paced environment.

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 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.

#LI-ONSITE