Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.

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Associate Principal Scientist, Analytical Development

About the Position

Reporting to 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 Include

  • Leads 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
  • Performs gap assessments of analytical methods in support of BLA readiness
  • Supports and execute an analytical strategic plan in support of product development and lifecycle management activities
  • Establishes the reference material and other relevant programs for late stage product development
  • Reviews or authors analytical development, qualification and validation reports
  • Contributes to technical reports, CMC documentation, and clinical and commercial regulatory filings as needed.
  • Analyzes and interpret experimental data, troubleshoot technical challenges, and propose solutions to drive continuous improvement in analytical methods.
  • Executes quality control assays to analyze lentiviral vectors, and cell products as needed.
  • Prepares, evaluates, and presents data internally to cross functional teams.
  • Generates and communicates research findings through presentations, and scientific publications.
  • Provides technical guidance, mentorship, and training to junior scientists within the team.

Required 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.

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How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

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.