Philadelphia, PA

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 with high unmet need, including systemic lupus erythematosus (SLE), myositis, systemic sclerosis, and generalized myasthenia gravis, and which uses a CD-19 binder that has an encouraging clinical tolerability profile. In addition to our CARTA candidate, CABA-201, we have a clinical-stage pipeline of Chimeric AutoAntibody Receptor T (CAART) cells targeted to the cells responsible for autoantibody-mediated autoimmune diseases.  Cabaletta Bio’s headquarters 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:

Reporting to the Senior Director, GCP Compliance, the GLP Quality Control Specialist is responsible for ensuring compliance with Good Laboratory Practices (GLP) within the organization. This role involves developing, implementing, and maintaining quality control processes to uphold the highest standards in laboratory activities. The GLP Quality Control Specialist will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all laboratory practices adhere to relevant regulatory requirements.

 

Responsibilities:

• Ensure that all Internal, Central and Local Clinical laboratory activities comply with Good Laboratory Practices (GLP) regulations and guidelines. Stay current with regulatory requirements and industry standards related to GLP.

 

• Develop, implement, and maintain quality control procedures to monitor and assess laboratory processes. Conduct regular reviews to identify areas for improvement and initiate corrective actions as needed.

 

• Assist in the planning  and conducting of internal audits to assess compliance with GLP standards. Coordinate external inspections and audits from regulatory agencies, ensuring preparedness and timely responses to findings.

 

• Oversee the creation, review, and approval of laboratory documentation, including SOPs (Standard Operating Procedures), protocols, and reports. Ensure that documentation is accurate, complete, and in compliance with GLP requirements. Ensure all TMF Lab related documentation are filed in a timely and accurate manner.

 

• Assist in providing training and guidance to laboratory personnel on GLP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures.

 

• Identify and assess potential risks related to GLP compliance. Develop and implement risk mitigation strategies to minimize the likelihood of compliance issues.

 

• Drive continuous improvement initiatives within the quality control function. Collaborate with relevant stakeholders to implement changes that enhance overall laboratory efficiency and quality.

 

• Effectively communicate with cross-functional teams, management, and regulatory agencies regarding quality control matters. Provide regular updates on compliance status, issues, and improvements.

 

Qualifications:

• Bachelors Degree in a scientific discipline
• Minimum of 2 years hands-on experience in biopharmaceutical operations, technical operations and/or quality operations
• Minimum of 1 year experience with Document Control within a GXP  environment, with specific familiarity with Trial Master File and Quality Management System controlled documents
• Extensive knowledge of GLP, GCP, ICH and FDA biologics regulations
• Demonstrated knowledge of document control systems, preferably electronic systems
• Demonstrated understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File
• Cell and gene therapy experience preferred

• Must be highly organized, an effective and proactive communicator verbally and in writing, have disciplined practices of maintaining electronic records in real-time, and be able to work independently.
• Strong team orientation and passion for continuous self-development.
• Experience in 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.