Associate Principal Scientist, Analytical Development

 

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first 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 Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com 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 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®

 

Position Description:               

 

This role is located in Center City, Philadelphia.

Reporting to the Sr. Director, Analytical Development, the talented and experienced Associate Principal Scientist contributes to development, qualification and validation of phase-appropriate analytical test methods for rese-cel products. The successful candidate will play a critical role in establishing and executing strategies for extended product characterization, ensuring robust, reproducible, and regulatory-compliant analytical methods to support process performance qualification (PPQ) and commercialization. They must address the complexity of living CART cell products, requiring innovative approaches to identify and monitor critical quality attributes (CQAs) and critical process parameters (CPPs) to ensure product consistency, product safety and efficacy and regulatory compliance.

The individual will provide technical expertise and leadership to Analytical Development Team to develop analytical frameworks related to method validation, lifecycle method management, stability program, reference material program, raw material testing for late stage clinical requirements. To achieve this, the individual will work closely with Quality & Compliance, Process Development, Manufacturing & Science Technology and Regulatory Affairs

 

Responsibilities:

  • Lead the development, optimization, and qualification/validation of analytical methods, as required to evaluate safety, purity, identity, potency of lentiviral vectors and cell therapy products, in compliance with relevant regulatory guidelines
  • Lead development of analytical methods for extended product characterization
  • Perform gap assessments of analytical methods in support of BLA readiness
  • Support and execute an analytical strategic plan in support of product development and lifecycle management activities
  • Establish the reference material and other relevant programs for late stage product development
  • Review or author analytical development, qualification and validation reports
  • Contribute to technical reports, CMC documentation, and clinical and commercial regulatory filings as needed.
  • Analyze and interpret experimental data, troubleshoot technical challenges, and propose solutions to drive continuous improvement in analytical methods.
  • Execute quality control assays to analyze lentiviral vectors, and cell products as needed.
  • Prepare, evaluate, and present data internally to cross functional teams.
  • Generate and communicate research findings through presentations, and scientific publications.
  • Provide technical guidance, mentorship, and training to junior scientists within the team.

 

Qualifications:

  • MS or PhD degree in a relevant science discipline with a minimum of 3-5 or 2-4 years of industry experience respectively in analytical development for cell therapy or biologics. 1-2 years of experience in late stage product development is preferred.
  • Expertise in development and validation of analytical assays for the characterization of cell-based products, including flow cytometry, ELISA/MSD, qPCR/dPCR/ddPCR, cell-based assays, potency assays and other advanced technologies.
  • Experience in analytical method lifecycle management, gap assessment and analytical method comparability.
  • Strong understanding of relevant regulatory guidelines and industry best practices (e.g., ICH, FDA, EMA) for analytical method qualification/validation.
  • Demonstrated communication (oral and writing) and interpersonal skills, with the ability to collaborate effectively in a multidisciplinary team environment and present technical information clearly and concisely.
  • Demonstrated analytical and problem-solving skills, with the ability to analyze complex data sets, identify trends, and propose data-driven solutions.
  • Demonstrated strong leadership qualities with a passion for mentoring and developing junior team members.
  • 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.

 

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